Professional Documents
Culture Documents
Guideline
Pressure Ulcer Treatment
Technical Report
National Pressure Ulcer Advisory Panel & European Pressure
Ulcer Advisory Panel
2009
Table of Contents
Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2
Suggest Citation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3
Limitations and Appropriate Use of This Guideline . . . . . . . .. . . . . . . . . . . 3
Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Guideline Developers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Executive Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Methodology for Guideline Development. . . . . . . . . . . . . . . . . . . . . . . . .. 20
International NPUAP-EPUAP Pressure Ulcer Classification System . . . . 29
Foreword
The International Pressure Ulcer Guideline summarizes recommendations and
supporting evidence for pressure ulcer prevention and treatment. It was
developed as a 4-year collaborative effort between the European Pressure
Ulcer Advisory Panel (EPUAP) and American National Pressure Ulcer Advisory
Panel (NPUAP). It provides a detailed analysis and discussion of available
research, critical evaluations of the assumptions and knowledge of the field, a
description of the methodology used to develop the guideline, and the
acknowledgments of editors, authors, and other contributors.
The Clinical Practice Guideline is intended for professionals interested in both
the recommendations for pressure ulcer care and the scientific evidence
supporting those recommendations. A Quick Reference Guide version is also
available that contains excerpts from the Clinical Practice Guideline. The Quick
Reference Guide version is intended for busy clinicians who need a quick
reference in caring for individuals with pressure ulcers and/or who are at risk
for developing pressure ulcers. Users should not rely on these excerpts alone.
This Pressure Ulcer Treatment Technical Report includes the evidence tables
used as a basis for guideline development. It is intended for researchers,
educators and clinicians who wish to more fully explore the research
supporting the treatment recommendations and evidence summaries
presented in the Clinical Practice Guideline.
Printed copies of the English editions of the Clinical Practice Guideline and
Quick Reference Guide are available through the NPUAP website
(www.npuap.org). The Quick Reference Guide has been translated into several
languages; translations are available on the EPUAP website (www.epuap.org).
The Prevention Technical Report and Treatment Technical Report are only
available in electronic version from NPUAP (www.npuap.org) and EPUAP.
The goal of this international collaboration was to develop evidence-based
recommendations for the prevention and treatment of pressure ulcers that
could be used by health care professionals throughout the world. An explicit
scientific methodology was used to identify and evaluate available research.
In the absence of definitive evidence, expert opinion (often supported by
indirect evidence and other guidelines) was used to make recommendations.
Suggested Citation
The EPUAP and NPUAP welcome the use and adaptation of this guideline at a
national and local level. However, we request citation as to the source, using
the following format:
National Pressure Ulcer Advisory Panel and European Pressure Ulcer Advisory
Panel. Pressure Ulcer Treatment: Technical Report. Washington DC: National
Pressure Ulcer Advisory Panel; 2009. Available at www.npuap.org.
Abstract
This guideline is the result of a collaborative effort between the American
National Pressure Ulcer Advisory Panel (NPUAP) and European Pressure Ulcer
Advisory Panel (EPUAP). A comprehensive literature review was conducted on
pressure ulcer prevention and treatment. A rigorous scientific methodology
was used to analyze available research and to make evidence-based
recommendations for the prevention and treatment of pressure ulcers. Drafts
of the guideline were made available to 903 individuals and 146
societies/organizations registered as stakeholders in 63 countries on 6
continents. All stakeholder comments were carefully considered by guideline
developers. Explicit recommendations and summaries of supporting evidence
are provided for the following aspects of pressure ulcer prevention: etiology,
risk assessment, skin assessment, nutrition, repositioning, support surfaces,
and special pressure ulcer preventive needs of patients in the operating room.
Recommendations and research were also summarized for a wide variety of
topics related to pressure ulcer treatment: classification of pressure ulcers,
assessment and monitoring of healing, the role of nutrition in healing, pain
assessment and management, support surfaces, principles of wound bed
preparation (i.e., cleansing, debridement, dressing selection, assessment and
treatment of infection), biophysical agents (e.g., electrical stimulation,
negative pressure wound therapy), surgery, and management in individuals
receiving palliative care. The NPUAP and EPUAP also agreed on an
international classification system for pressure ulcers with the hope that it
will be adopted internationally and therefore help reduce discrepancies in
international reporting of pressure ulcer incidence and prevalence.
NPUAP
Janet Cuddigan, PhD, RN CWCN
(NPUAP Co-Chair & Editor-in-Chief)
University of Nebraska Medical Center, Omaha, NE, USA
Diane K. Langemo, PhD, RN, FAAN
(NPUAP Co-Chair)
University of North Dakota, Grand Forks, ND, USA
Mona M. Baharestani, PhD, ANP, CWON, CWS
East Tennessee State University, Johnson City, TN, USA
James H. Quillen
Veterans Affairs Medical Center, Johnson City, TN, USA
Consultants
Steven Black, MD, FACS served as a medical consultant to the Guideline Development
Group. Dr. Black is a plastic surgeon at The Nebraska Medical Center, Omaha, NE, USA.
Phillip Smith, MD served as a consultant on the assessment and management of
infection. Dr. Smith is a Professor in Internal Medicine and Chief of the Infectious
Diseases Section at the University of Nebraska Medical Center in Omaha, NE, USA. He
is a Fellow of the American College of Physicians and the Infectious Diseases Society of
America.
Treatment
Classification of Pressure Ulcers: Joyce Black (Leader), Janet Cuddigan, Tom Defloor &
Courtney Lyder Assessment & Monitoring of Healing: Janet Cuddigan (Leader),
Susan Garber & Diane Langemo Role of Nutrition in Pressure Ulcer Healing: Mary
Ellen Posthauer (Leader), Becky Dorner, David Thomas & Steven Black Pain
Assessment & Management: Diane Langemo (Leader) & Barbara Bates-Jensen
Support Surfaces for Treatment of Pressure Ulcers: Evan Call (Leader), Joyce Black,
Acknowledgments
The European Pressure Ulcer Advisory Panel (EPUAP) and National Pressure
Ulcer Advisory Panel (NPUAP) gratefully acknowledge the contributions of the
following individuals and groups for financially supporting the presentation
and dissemination of the guideline. All financial contributions were made
after the guideline was developed and in no way influenced the development
of the guideline or its content. Financial contributions are being used for the
printing and dissemination of the guideline. The following companies
provided unrestricted education grants:
NPUAP Donors
Platinum Level Contributor ($20,000 or greater)
Kinetic Concepts, Inc
Gold Level Contributor ($10,000 to $19,999)
American Medical Technologies, Inc
Silver Level Contributors ($1,000 to $9,999)
Coloplast
EHOB, Incorporated
Genesis HealthCare
HCR ManorCare
Executive Summary
Significance
Pressure ulcers are painful, costly, and often preventable complications that
threaten many individuals in hospitals, nursing homes, and home care. They
remain a frequently occurring health care problem throughout the world. A
European pilot survey undertaken by the European Pressure Ulcer Advisory
Panel (EPUAP), which included 5947 patients located in Belgium, Italy,
Portugal, Sweden, and the United Kingdom, found an overall prevalence of
18.1%, although there was some variation between countries (1). In 2001, The
National Pressure Ulcer Advisory Panel (NPUAP) estimated that pressure ulcer
prevalence in American hospitals was 15% and the incidence 7% (2).
More recent national studies fail to demonstrate sustained significant
declines in American hospitals or other health care settings (3, 4). Prevalence
and incidence rates are often higher in unique populations such as those
receiving palliative care in home hospice (5, 6), those with spinal cord injuries
(7), and in critical care units (8). Pressure ulcers represent a major burden of
sickness and reduced quality of life for patients and their carers (911).
Increased morbidity and mortality associated with pressure ulcer
development in hospitalized patients is documented in multiple studies (12
15). Hospital lengths of stay, readmission rates, and hospital charges are
greater in patients who develop pressure ulcers than in those remaining
ulcer-free (1214, 16). The development of a single pressure ulcer in U.S.
hospitals can increase a patients length of stay five-fold and increase hospital
charges by $2,00011,000 (12). Recent European cost-models to highlight the
cost of illness associated with pressure ulcers have indicated that the total
costs may consume between 1% in the Netherlands (17) and 4% in the United
Kingdom (18) of health care expenditure.
Guideline Development
The European Pressure Ulcer Advisory Panel (EPUAP) and the American
National Pressure Ulcer Advisory Panel (NPUAP) collaborated to develop
guidelines on the prevention and treatment of pressure ulcers. The EPUAP
took the lead on the pressure ulcer prevention guideline in collaboration with
the NPUAP, and the NPUAP took the lead on the pressure ulcer treatment
guideline in collaboration with the EPUAP. The guidelines were produced by a
multidisciplinary Guideline Development Group (GDG) and several Small
Working Groups (SWGs) consisting of members of both EPUAP and NPUAP.
The GDG determined and monitored the guideline development process. The
entire process of developing the guideline could be followed by stakeholders
on a website (www.pressureulcerguideline.org).
The first step in the guideline development process was identifying the
evidence. The GDG conducted an extensive review of the literature on
pressure ulcer prevention and treatment in several electronic databases using
a sensitive search strategy. All retrieved references were screened by the
GDG on predetermined inclusion criteria. In a second step, the retrieved
evidence was evaluated, and thereafter the full papers were divided
according to topic and sent to the relevant SWGs. The members of the SWGs
10
Guideline Recommendations
Guidelines are systematically developed statements to assist practitioner
and patient decisions about appropriate health care for specific clinical
conditions. The recommendations may not be appropriate for use in all
circumstances. The decisions to adopt any particular recommendation must
be made by the health care professional in light of available resources and
the circumstances presented by the individual patient. Nothing contained
in this book is to be considered medical advice for specific cases. This book
and any recommendations herein are intended for educational and
informational purposes only. Generic names of products are provided.
Nothing in this guideline is intended as an endorsement of a specific
product.
Prevention
The prevention guideline comprises seven topics: etiology, risk assessment,
skin assessment, nutrition, positioning, support surfaces, and special
populations: operating room patients.
Etiology
The etiology section is an introductory section to the prevention guideline.
The procedure for the development of this section was different from that
for the other guideline sections. As etiology research is more basic science,
only a few studies were retrieved with the literature search strategy.
Therefore, this section started from the current state of the art and
knowledge on etiology and gives a brief overview consisting of four items:
mechanical load/magnitude and time, tissue reactions at different types of
11
12
13
14
Treatment
Recommendations and research were also summarized for a
comprehensive array of topics related to pressure ulcer treatment.
Pressure Ulcer Classification
Pressure ulcer treatment begins with an accurate diagnosis and classification
of pressure ulcers. A validated pressure ulcer classification system should be
used. Professionals should be educated about the appearance of different
types of tissue, differentiating pressure ulcers from other types of wounds
and skin conditions, and special techniques for assessing darkly pigmented
skin. Inter-rater reliability should be confirmed. Pressure ulcers on mucous
membranes should not be classified using existing classification systems.
Assessment and Monitoring of Healing
An initial holistic assessment should be performed on all patients with
pressure ulcers. Reassess the patient and treatment plan if the ulcer fails to
show signs of healing within two weeks. The pressure ulcer should be
assessed at least weekly; specific strategies for assessment are provided.
Simple documentation of pressure ulcer status is not enough. The
professional should continuously monitor progress toward healing,
adjusting treatment plans as needed. Two tools for monitoring pressure
ulcer healing are recommended.
Role of Nutrition in Pressure Ulcer Healing
Nutritional status should be assessed for all individuals with pressure ulcers
initially, with a change in condition, and when the ulcer is not showing signs
of healing. Specific recommendations are provided to address the caloric,
protein, fluid, vitamin, and mineral intake necessary to support healing.
Pain Assessment and Management
Pressure ulcer-related pain is a common complication that is often undertreated. Pain should be evaluated in all patients with pressure ulcers,
including infants, children, and cognitively impaired adults. Specific
recommendations are provided for preventing pain, managing general pain,
reducing debridement pain, and managing chronic pain.
15
16
17
References
(1) Vanderwee K, Clark M, Dealey C, Gunningberg L, Defloor T. Pressure ulcer
prevalence in Europe: a pilot study. J Eval Clin Pract. 2007;13(2):227-32.
(2) National Pressure Ulcer Advisory Panel. Pressure ulcers in America: prevalence,
incidence, and implications for the future. Cuddigan J, Ayello E, Sussman C, editors.
Reston, VA: NPUAP; 2001.
(3) Russo CA, Elixhauser A. Hospitalizations related to pressure sores, 2003.
Healthcare Cost and Utilization Project. Rockville, MD: Agency for Healthcare
Research and Quality; 2007.
(4) VanGilder C, MacFarlane GD, Meyer S. Results of nine international pressure
ulcer prevalence surveys: 1989 to 2005. Ostomy Wound Manage. 2008;54(2):40-54.
(5) Reifsnyder J, Magee HS. Development of pressure ulcers in patients receiving
home hospice care. Wounds. 2005;17(4):74-9.
(6) Tippett AW. Wounds at the end of life. Wounds. 2005;17(4):91-8.
(7) Cardenas DD, Hoffman JM, Kirshblum S, McKinley W. Etiology and incidence of rehospitalization after traumatic spinal cord injury: a multicenter analysis. Arch Phys
Med Rehabil. 2004;85(11):1757-63.
(8) Shahin ESM, Dassen T, Halfens RJG. Pressure ulcer prevalence and incidence
in intensive care patients: a literature review. Nursing In Critical Care.
2008;13(2):71-9.
(9) Franks PJ, Moffatt CJ, Ellison DA, Connolly M, Fielden S, Groarke L, et al. Quality
of life in venous ulceration: A randomized trial of two bandage systems. Phlebology.
1999;14:95-9.
(10) Hopkins A, Dealey C, Bale S, Defloor T, Worboys F. Patient stories of living
with a pressure ulcer. J Adv Nurs.2006;56(4):345-53.
(11) Nixon J, Nelson EA, Cranny G, Iglesias CP, Hawkins K, Cullum NA, et al. Pressure
relieving support surfaces: a randomised evaluation. Health Technol Assess.
2006;10(22):iii-x, 1.
18
19
20
Participants
Guideline Development Group. The EPUAP and NPUAP nominated six
representatives each to form the Guideline Development Group (GDG).
The EPUAP and NPUAP each had six votes during joint deliberations, with
the majority deciding. Examination of the evidence and consensus building
preceded all votes. Minority opinions were represented in meeting
minutes.
The GDG determined and monitored the guideline development process. As
an initial step, the GDG reviewed the literature on guideline development
methodologies and internationally developed criteria evaluating the quality of
guidelines. The group agreed upon a methodology that was sufficiently clear
to be reliably and consistently followed by the small working groups of
international experts reviewing the evidence and drafting the
recommendations, yet rigorous in meeting quality standards. This guideline
development methodology is described in detail below.
GDG members and others involved in the actual development of the
guideline were screened for potential conflicts of interest. Representatives of
industry were excluded from developmental groups but were invited to
participate as stakeholders.
Small Working Groups. The guideline content was broken down into topics,
and Small Working Groups (SWGs) were formed to review the evidence
available for each topic. Guideline development was an iterative process,
with GDG and SWG members maintaining close communication. Evidence
summaries and draft recommendations developed by the SWGs were
reviewed by the GDG for (1) comprehensiveness and accuracy of literature
reviews, (2) methodological rigor in evidence analysis and application to
clinical practice, and (3) clarity and appropriate- ness of recommendations
for an international audience.
21
Methods
The steps of the guideline development process are delineated below. For
simplicity and clarity, the process is described as linear and sequential;
however, the actual process was iterative, with multiple drafts developed and
progressively improved based on ongoing communication among GDG
members, SWG members, and stakeholders.
Step 1: Identifying the Evidence
Databases. To identify the scientific literature on pressure ulcer prevention
and treatment, several electronic data- bases were consulted, such as
PubMed, CINAHL, EMBASE, The Cochrane Database of Systematic Reviews,
The Cochrane Central Register of Controlled Trials, Health Technology
22
23
24
25
26
Conclusion
The EPUAP and NPUAP Guideline Development Group is pleased to present
the EPUAP-NPUAP Pressure Ulcer Prevention and Treatment Guideline. The
27
References
(1) Critical Appraisal: Notes and Checklists. Edinburgh: Scottish Intercollegiate
Guidelines Network; [cited September 24, 2009]; Available from: http://
www.sign.ac.uk /methodology/ checklists.html.
(2) Sackett DL. Rules of evidence and clinical recommendations on the use of
antithrombotic agents. Chest. 1989;95(2 Suppl):2S-4s.
(3) Straus SE, Richardson WS, Glasziou P, Haynes RB. Evidence-based medicine: How
to practice and teach EBM. Third ed. Toronto: Elsevier Churchill Livingstone; 2005.
28
29
30
31
Beeckman D, Schoonhoven
L, Boucqu H, Van Maele
G, Defloor T. Pressure
ulcers: e-learning to
improve classification by
nurses and nursing
students. J Clin Nurs.
2008;17(13):1697-707.
Type of Study
Sample
Intervention(s)
Nursing students
Qualified nurses from 7
hospitals, 7 nursing
homes, 1 home care
agency and 5 schools of
nursing
Classified 20 photographs of
normal skin (1), blanchable
erythema (1), stage I (3), II
(3), III (3), IV (3), moisture
lesions (3) and combined
ulcers (3) (both moisture
and pressure)
Beeckman D, Schoonhoven
L, Fletcher J, Furtado Kt,
Gunningberg L, Heyman H,
et al. EPUAP classification
system for pressure ulcers:
European reliability study.
J Adv Nurs.
2007;60(6):682-91.
Survey of 1452
nurses from 5
European countries
familiar with EPUAP
PrU classification
system
Describe the
accuracy of
registered general
nurses on pressure
ulcer grades using
EPUAP grading
N = 52
32
Self-assessment of expertise of
identifying ulcers
Results
Limitations
Type of Study
Sample
Intervention(s)
7 researchers, 20 staff
members and 17
pressure ulcer nurses
system
What was the effect
of education on the
accuracy?
Defloor T, Schoonhoven L.
Inter-rater reliability of the
EPUAP pressure ulcer
classification system using
photographs. J Clin Nurs.
2004;13(8):952-9.
Defloor T, Schoonhoven L,
Vanderwee K, Weststrate
J, Myny D. Reliability of the
European Pressure Ulcer
Advisory Panel
classification system. J Adv
Nurs. 2006;54(2):189-98.
Development and
validity testing of a
series of
photographs of
pressure ulcers and
moisture lesions
using the EPUAP to
establish a "gold
standard" for
accuracy of diagnosis
examine the
interrater and
intra-rater reliability
of classifying
pressure ulcers
according to the
EPUAP classification
system when using
photographs
of pressure ulcers
and incontinence
lesions
Phase 1: 65 photos
were presented in a
random order to 473
nurses who were
participating at a
Congress for Wound
Care in Belgium, the
Netherlands and
Finland.
Phase 2: Eighty-six
nurses from a university
hospital in Belgium
participated in the
A set of 56 photographs of
normal skin, blanchable
erythema, pressure ulcers
and incontinence lesions
was used.
If erythema was visible on a
photograph, a second
photograph was also
shown. On this second
photograph a transparent
pressure disk was pressed
onto the erythema so that
the extent to which the
33
Results
Limitations
Type of Study
Data from 20
hospitals. Hospitals
deviated from our
specification of n =15
PrUs and p =6 raters
Hart S, Bergquist S,
Gajewski B, Dunton N.
Reliability testing of the
National Database of
Nursing Quality Indicators
pressure ulcer indicator. J
Nurs Care Qual. 2006;21(3
(Print)):256.
256 individuals at 48
randomly sampled
National Database of
Nursing Quality
Indicators (NDNQI)
member hospitals.
Approximately 54%
(n = 26) of the
participating
hospitals were
academic medical
Sample
Intervention(s)
To construct a model to
estimate the reliability
of rating PrUs from
patients in NDNQI
hospitals. Stages I to IV
are ordinal and
unstageable, because it
combines III and IV (and
in this case DTI) does
not fit this numeric
relationship
Part 1 of the test asked
participants to identify
whether the wound was
a pressure, venous,
arterial, or diabetic foot
ulcer.
For part 2, individual
participants were asked
to stage the pressure
ulcer in each of the
17 photographs or to
34
Results
Limitations
Type of Study
Sample
Intervention(s)
centers or teaching
hospitals and 33%/
held Magnet status.
classify it as
unstageable.
Participants were
instructed to use
NPUAP guidelines when
staging the wound or
classifying it as
unstageable.
For part 3 of the test,
participants were asked
to read 5 scenarios and
determine from each
whether the patient's
pressure ulcer was
nosocomial or
community acquired.
35
Results
Limitations
Type of Study
Sample
Intervention(s)
36
Results
Limitations
Type of Study
Sample
12 lesions with
blanchable erythema
classified as moisture
lesions
A total of 143
patients consented
to participate in the
pilot study (April to
July 1998) and the
main study
(September 1998 to
May 1999), including
93 elective and 50
acute patients.
To detect differences in
mean blood flow
perfusion units)
between clinical skin
grades Skin lesions
classified as:
0 No skin changes
1a Redness to skin
(blanching)
1b Redness to skin
(nonblanching)
1b Redness to skin
(nonblanching) plus one
or more:
Pain
Induration
Heat
Edema
Discoloration
(specify)
2 Partial thickness
wound involving
epidermis/dermis only
3 Full thickness wound
involving subcutaneous
tissue
4 Full thickness wound
through subcutaneous
tissue to muscle or
bone
5 Black eschar
Intervention(s)
37
Results
Limitations
Type of Study
Sample
Intervention(s)
0 No skin changes
1a Redness to skin
(blanching)
1b Redness to skin (nonblanching)
2 Partial thickness wound
involving
epidermis/dermis only (i.e.
skin break or blister)
3 Full thickness wound
involving subcutaneous
tissue
4 Full thickness wound
through subcutaneous
tissue to muscle or bone
5 Black eschar
Plus a minimum
sample size of 42 scans
was estimated using
pilot study data. This
was based on an
analysis of variance
with 95 percent power
at the 5 percent
significance level.
Nixon J, Thorpe H, Barrow
H, Phillips A, Andrea
Nelson E, Mason SA, et al.
Reliability of pressure ulcer
classification and
diagnosis. J Adv Nurs.
2005;50(6):613-23.
38
Results
Limitations
Type of Study
Sample
Stud. 2007;44(8):1316-23.
Intervention(s)
grade 3: Deep loss of skin,
muscles and tendons are
visible and possibly
affected; Pressure ulcer
grade 4: Deep loss of skin
with affection of bones.
Random assignment
of 66 nurses to a
decision tree to
classify pressure
ulcers. Nurses
randomly selected
from 100 at the
General University
Hospital of Elche,
Alicante, Spain. All
had a similar level of
experience and often
cared for patients
with chronic wounds.
At baseline participants
were given a sealed
envelope containing
three clinical case
studies, each of which
briefly described the
health status of a
patient and his or her
pressure ulcer, and
included photographs
of the site and aspect of
the wounds.
Results
Limitations
Case II**
Case III***
ConNo.
(%)
Exp.
No. (%)
Con No.
(%)
Exp. No.
(%)
Con No.
(%)
Exp. No.
(%)
Accurate
29 (85.3)
25 (78.1)
18 (52.9)
21 (65.6)
21 (61.8)
14 (43.8)
Inaccurate
5 (14.7)
7 (21.9)
16 (47.1)
11 (34.4)
13 (38.2)
18 (56.2)
There was no statistically significant difference between the grades selected by the two groups.
Overall accuracy rates were:
Case I: 81.8% (54/66)
Case II: 59.1% (39/66)
Case III: 53.0% (35/66)
39
Type of Study
Sample
Intervention(s)
Results
Retrospective
analysis.
Measurement of 10
fully healed stage IV
pressure ulcers in the
pelvic area of 9 patients
were examined
retrospectively.
Prospective study
40
Limitations
Type of Study
Secondary analysis.
Sample
Intervention(s)
calculated by means of
bedside measurements and
Jeltrate volume calculated
weight.
48 patients:
25 men and 22 women.
With 56 full thickness
stage III and IV that
were dressed with
hydrocolloid dressing
for mean of 56 days
prior to the study
enrollment.
41
Results
bedside measurements and volumes
determined by Jeltrate impression
(r=.892). Jeltrate impression volumes
tended to yield smaller
measurements than calculated
volumes, especially in larger than 10
cm3 wounds. There was tendency for
Jeltrate impression volume to over
predict calculated volumes in smaller
wounds less than 10 cm3.
Kaplan-Meier time until 100 % healing
time curve showed that the median
time to healing was 69 days. Healing
can be expected to be seen in 25% of
the patients after 50 days, where 75%
of patients can be expected to heal
after 243 days. A 50% reduction in
wound size can be expected after 15
days, where half of all wounds
exhibited an 80 % reduction in ulcer
area after 40 days.
Nutrition status at baseline
significantly influence the time to
healing. Patients with satisfactory/
poor nutritional status at baseline
took a mean of 20 days longer to heal
as compared to patient who had a
good nutritional status (P=0.01).
Patients who were confused/
disoriented healed after a median of
86 days (mean 139, SE 28.7).
Median time to reach 100% healing
for completely immobile patients was
86 days (M 124, SE 27.5) compared to
53 days (M 49, SE 6.5) for patient with
restricted mobility, the differences
was not statistically significant
(p=0.1).
The mean time to healing pressure
ulcers in patients 60 -69 years old was
34.9 days (SE 3.7). Patients< 60 years
of age healed after a mean of 56.4 (SE
6.6) and patients 70 to 79 and >= 80
years of age heal after 78.5 (SE 10.1)
Limitations
Type of Study
Sample
Intervention(s)
Results
Limitations
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Exploratory
descriptive study,
inter-rater reliability
study.
16 wound care
professional staff; 11
registered nurses and
five physicians.
Controlled
experimental study.
42
Results
Limitations
It must be emphasized
that these predictive
values rely on the
availability of a very
accurate measurement
system.
Type of Study
Sample
Intervention(s)
the wound are scanned in a
fixed order, the computer
calculated the dimensions,
area and volume, of the
defect.
Descriptive study
A questionnaire was
developed using
recommendation on wound
assessment from the
Agency of Health Care
Policy and Research clinical
practice guideline on
pressure ulcer treatment.
The participants were
allowed to add additional
information, and were
asked to include a copy of
current wound
documentation form.
Gethin G, Cowman S.
Wound measurement
comparing the use of
acetate tracings and
Visitrak digital planimetry.
J Clin Nurs.
Retrospective
comparative study.
25 acetate wound
tracings of superficial
lower limb wounds
which are < 10 cm2, and
25 acetate tracings of
superficial lower limb
43
Results
was found to provide better
prediction of the time to complete
healing than percentage change of
the edge length.
it was found that if the percentage
change in area in the third week was
multiplied by the factor 0.11 it would
have predicted the total time to
complete healing to within one week
in just under 50% of the ulcers.
Pressure ulcer is the most commonly
treated (97%) type of wound in U.S
home health care agencies.
The average number of wounds seen
by an agency is 152/month.
The documentation forms used by
these agencies most commonly asked
clinician to document: date, site, or
location of the wound, size by length
and width, tissue type and color, the
surrounding skin description, type
and amount and of drainage, and
odor of the wound.
74% of respondents do wound
assessment at least weekly, 26% do it
less frequently or inconsistently.
54% of respondents monitor healing
by: change in length and width,
drainage, wound bed, wound edges,
pain, and odor.
90% of the agencies use the NPUAP
guidelines in their wound
assessment.
The comparison of questionnaire
responses and documentation data
revealed a general lack of universal
documentation standards, especially
in: documented medications, pain,
compliance, and peri-wound area.
The difference between area
measurements was not clinically
significant between the two
measures (t=0.995, d.f.= 24,
p=0.330). In the wound group<10
cm2, the mean wound measurement
Limitations
Type of Study
2006;15(4):422-7.
Descriptive
correlational study.
Sample
Intervention(s)
44
Results
Limitations
range of practitioners or
centers because the
study was conducted in
one center where a high
degree of skill is available
in wound measuring. The
study did not study cavity
wounds or wounds in
difficult areas, and the
depth gauge of the cavity
wounds was not
evaluated using the
Visitrak.
Type of Study
Sample
Intervention(s)
Haghpanah S, Bogie K,
Wang X, Banks PG, Ho CH.
Reliability of electronic
versus manual wound
measurement techniques.
Arch Phys Med Rehabil.
2006;87(10):1396-402.
Repeated measures.
4 trained blinded
observers, drawn from
the clinical and research
staff of the spinal cord
injury unit.
Comparative study.
66 raters,
representative of a
verity of skill levels in
wound measurement.
32 upper-division
undergraduate nursing
students, 27 staff
45
Results
smaller.
For large wounds inter-observer
variation was significant for all
measurement techniques and intraobserver variation was not significant
for any measurement technique.
For small wounds intra-observer
variation was not significant for linear
and Visitrak but was significant for
VeV, were inter-observer variation
showed the reveres result.
The linear measurement technique
the lowest accuracy for all
measurement techniques and all
observers; it showed very high RMSE
values for both large (mean =110)
and small wounds (mean = 29). For
large wounds Visitrak and VeV
showed the lowest RMSE values, with
VeV slightly better (mean= 22) than
Visitrak.(mean = 27). For small
wounds Visitrak and VeV showed the
lowest RMSE values, with Visitrak
even lower (mean = 3) than VeV
(mean = 5).
There was a significant evidence
(P<0.001) than counting squares took
longer than VISITRAK Digital to
measure each of the template areas.
There was a significant evidence
(P<0.01) that the counting squares
method of the estimating the
template area was more variable
than VISITRAK Digital estimating the
template area was more variable
than VISITRAK Digital for each of the
templates.
1-The smallest relative bias was
associated with the SPG method. The
ruler length and width measurement
reflected the largest bias regardless
of wound shape.
2-The SPG area had the smallest SEM
for each wound shape. Both length
Limitations
Type of Study
Care.1998;11(7):337-43.
Sample
Intervention(s)
Majeske C. Reliability of
wound surface area
measurements. Phys Ther.
1992;72(2):138-41.
Descriptive
comparative study.
31 patients with
unhealed venous stasis
ulcer.
Descriptive
comparative study.
14 patients were
studied. 7 patients had
healing pilonidal sinuses
and 7 patients had
abdominal wall cavity
wound arising from
46
Results
and width methods best measured
circular wounds, followed by the Lshaped and the pear shaped wounds.
Tracing worked best for the pearshaped wounds, whereas SPG area
had the smallest SEM for the Lshaped wound.
3-The inter-rater reliability of average
rating was high for all techniques.
The clinically relevant reliabilities for
single rating were low(.3-.53), except
for the SPG area technique (.87).
4-Intra-rater reliability was high for
the tracing method and low for the
SPg area method, with the two length
and width method between the
tracing and the SPG area methods.
The overall results of this study
indicate that: the computer (SPG)
area technique was found to be the
most accurate and least biased for
two-dimensional wound
measurement.
Intra-tester reliability for each
therapist using the 4 methods of
calculating wound area was high, all
correlation coefficient were .99.
Inter-tester reliability was high the
ICC value ranged from .97-.99.
Limitations
Type of Study
Sample
Intervention(s)
surgical procedures.
Descriptive
exploratory study.
Sugama J, Matsui Y,
Sanada H, Konya C, Okuwa
M, Kitagawa A. A study of
the efficiency and
convenience of an
advanced portable Wound
Measurement System
(VISITRAK). J Clin Nurs.
2007;16(7):1265-9.
Descriptive
correlational study.
47
Results
(0.79. P = 0.001). comparing the
parameters during healing follow-up;
the volume, area, and circumference
measurement followed a similar
pattern in all the patients until
wound closer, with the correlation
between area and circumferences
was 0.94 (p<0.001), and the between
volume and circumference was 0.80
(p<0.01).
The mean scores of the PUSH were
different indicating a sensitivity to
change and scores were consistent
with outcome (P: 63). So in
conclusion the PUSH tool represents
an excellent starting point to validate
healing of venous ulcer (P: 64).
Limitations
Type of Study
Sample
Descriptive study
Inter-rater reliability
study.
Intervention(s)
each assessor with a digital
planimetry.
Convenience of the
VISITRAK was assessed by
recording the time it took to
calculate wound area in the
time taken to trace the
wound and measure the
area by VISITRAK
measurement system, and
the time required for
scanning and measurement
using the digital planimetry.
Two types of wound images
were entered to the
program: 1) securing a
wound tracing to the
computer screen and
recording the outline with
the mouse-controlled
graphics cursor, 2) working
with an image file derived
from a digital camera or
camcorder, saved onto
operation of the program.
Calibration and
measurement were done.
Each polygons outlines was
traced a total of 10 times
and the results entered into
SPSS for windows (release
10.0) spreadsheet. Group
means, standard deviations,
and coefficients of variation
(standard deviation divided
by the mean) were then
calculated. The significant of
difference between the true
and the measured result
was investigated using t-test
(p<0.05).
The new technique is a
variation of the Stereophotogrammetry method of
wound measurement. The
48
Results
Limitations
Type of Study
Cross-sectional
comparative study.
Sample
Intervention(s)
Total of 73 patients
with chronic wounds:
36 were with venous
stasis ulcers and 37 with
decubitus ulcers.
49
Results
Limitations
Type of Study
Sample
Intervention(s)
Benati G, Delvecchio S,
Cilla D, Pedone V. Impact
on pressure ulcer healing
of an arginine-enriched
nutritional solution in
patients with severe
cognitive impairment. Arch
Gerontol Geriatr.
2001;7:43-7.
Randomized, cohort,
clinical trial
2 week intervention
Received oral nutritional
supplementation enriched
with protein (37 g/d) or
protein plus arginine (7.5
g/d), zinc (25 mg/d), and
antioxidant vitamins
A: Normal hospital diet
B: Hospital diet + High
protein calorie solution
C: Hospital Diet +ONS is
caloric, isonitrogenous
enriched in Arginine,
vitamins and trace elements
with antioxidant effects
Control: Standard diet, 1800
cal/day
Nutrition Intervention for
15 days: 2 ONS/day, each
providing 200 kcal, 30%
protein, 20% fat, 50%
carbohydrate, 1.8 mg zinc,
15 mg vitamin C
(Jacquemaire-Sante;
Nutricia; Clintec-Sopharga)
Bourdel-Marchasson I,
Barateau M, Rondeau V,
Dequae-Merchadou L,
Salles-Montaudon N,
Emeriau JP, et al. A multicenter trial of the effects
of oral nutritional
supplementation in
critically ill older
inpatients. GAGE Group.
Groupe Aquitain
Geriatrique d'Evaluation.
Nutrition. 2000;16(1):1-5.
19 wards stratified: 9
wards randomly
selected for ONS
intervention
n=672; 377 in control;
295 in ONS
>60% female; Age =83.3
years; BW=55.2-60.2 kg
Control group at higher
risk of PrU per Norton
and Kuntzmann score
ONS group at higher
risk of PrU per serum
albumin levels
Results
Group C: Pressure sore status tool
(PSST) scores for patients on the oral
supplementation exhibited rapid
improvement in pressure ulcer
healing, compared to patients on the
standard hospital diet with no
supplementation. Patients receiving
the protein + arginine + zinc +
antioxidant supplement had the
lowest PSST scores.
Sample size
No statistical analysis
Randomization by center
not individual
Different baseline risks of
study groups
No information on other
medical interventions
Evidence Level = I
Desneves KJ, Todorovic BE,
Cassar A, Crowe TC.
Treatment with
supplementary arginine,
vitamin C and zinc in
patients with pressure
ulcers: a randomized
controlled trial. Clin Nutr
2005; 24:979-987.
Randomized clinical
trial
Determine
nutritional status of
patients dx with preexisting PrU &
determine whether
nutrients putatively
implicated in PrU
n=16
Age: 37-92 years; BMI =
16.4-28.1
Stage 2, 3, 4 PrU
3 week intervention
A: Standard hospital diet
B: Standard diet + 2 highprotein/energy ONS (500
kcal, 18 g protein, 72 mg
vitamin C, 7.5 mg zinc;
Resource Fruit Beverage,
Novartis)
C: Standard diet + 2 highprotein/energy
Body weight
Blood biochemistry
Pressure ulcer severity: PUSH scores
Food and fluid intake
50
Sample size
Evidence Level = II
Guenter P, Malyszek R,
Bliss DZ, Steffe T, O'Hara D,
LaVan F, et al. Survey of
nutritional status in newly
hospitalized patients with
stage III or stage IV
pressure ulcers. Adv Skin
Wound Care. 2000;13(4 Pt
1):164-8.
Type of Study
Sample
healing (arginine,
vitamin C, zinc) will
improve rate of PrU
healing
Open Intervention
Study Multicenter,
open intervention,
non-placebo
controlled clinical
study
No intervention
Body weight
Blood biochemistry
Nutritional intake
Type of PrU
Effectiveness of oral
nutritional
supplement that is
rich in protein,
enriched in arginine,
vitamin C, and zinc,
on healing of
pressure ulcers
Descriptive
Study(Prospective
and Retrospective)
Intervention(s)
Examine the
nutritional status of
newly hospitalized
patients with Stage
III or Stage IV PrU
51
Results
Significant (p<0.05) improvements in
SH scores in Diet C compared to
baseline (9.4 vs. 4.4 at week 2, 2.6 at
week 3)
Significantly (p<0.05) lower PUSH
scores at week 3 in Diet C (2.6) vs.
Diets A (7.0) & B (6.0)
Diet A: significant (p<0.05)
improvements in PrU healing
Diet C: 2.5 fold greater improvement
in pressure ulcer healing after 3
weeks compared to other 2 diet
groups
No differences in energy & protein
intakes across groups
Significantly (p<0.05) higher intakes
of arginine, vitamin C, zinc in Diet C
After 3 Weeks:
Significant reductions (29%) in wound
area from 23.6 cm2 to 19.2 cm2
(p<0.001)
Median healing of 0.34 cm2 per day
Trend in reduction of amount of
exudates in infected ulcers (p=0.012)
Significant reduction in incidence of
necrotic tissue (p=0.001)
No significant change in body weight,
BMI
ONS consumption = 1.9 packs/day
37% perceived adequate oral intake,
29% took 75-100%, 34% took 50-75%
of required energy intakes
No effect of intervention, i.e.
improvements in nutritional status of
depleted patients
Majority of patients were elderly
(58%), & females (53%). Stage III
sacral ulcers most common (74.2%).
Most patients were below UBW, had
low serum prealbumin and albumin
levels (88% and 92%). 75% of patients
had moderately low or severely low
serum prealbumin levels. 59% of
patients had low or severely low
serum albumin levels. Nutritional
Type of Study
Sample
Intervention(s)
Results
intakes were inadequate to meet
needs of patients, met 55% of needs
Evidence Level = V
Horn SD, Bender SA,
Ferguson ML, Smout RJ,
Bergstrom N, Taler G, et al.
The National Pressure
Ulcer Long-Term Care
Study: pressure ulcer
development in long-term
care residents. J Am
Geriatr Soc.
2004;52(3):359-67.
Retrospective, cohort
study
Identify resident,
treatment, facility
characteristics
associated with PrU
development in longterm care residents
95 LTC in US
1524 residents, >18 y,
>14 d LOS, at risk of
developing PrU, Braden
Score <17 on entry
No intervention
Over 12 weeks:
Resident characteristics
Treatment characteristics
Staffing ratios
Facility characteristics
PrU development during study
n=103; placebo=52;
ONS=51
Age: 81 years; BMI=24
Published randomized
controlled trials
Evidence Level = V
Also in Table on
Assessment
Houwing RH, Rozendaal M,
Wouters-Wesseling W,
Beulens JWJ, Buskens E,
Haalboom JR. A
randomised, double-blind
assessment of the effect of
nutritional
supplementation on the
prevention of pressure
ulcers in hip-fracture
patients. Clin Nutr.
2003;22(4):401-5.
Double-blind,
randomized,
placebo-controlled
clinical trial
Effect of nutritional
supplementation on
incidence of PrU in
hip-fracture patients
at risk of developing
PrU
Evidence Level = II
Langer G, Schloemer G,
Knerr A, Kuss O, Behrens J.
Nutritional interventions
for preventing and treating
pressure ulcers. Cochrane
Database Syst Rev.2003;(4)
CD003216.
Systematic review
Evaluate
effectiveness of
enteral and
parenteral nutrition
on the prevention
and treatment of
52
Convenience sample
No data on type of
nutritional interventions
and its impact on PrU
Small studies
Methodological issues
Type of Study
Sample
Intervention(s)
pressure ulcers
Langkamp-Henken B,
Herrlinger Garcia KA,
Stechmiller JK, Nickerson
Troy JA, Lewis B, Moffatt L.
Arginine supplementation
is well tolerated but does
not enhance mitogeninduced lymphocyte
proliferation in elderly
nursing home residents
with pressure ulcers. JPEN
J Parenter Enteral Nutr.
2000;24(5):280Evidence Level = II
Lee SK, Posthauer ME,
Dorner B, Redovian V,
Maloney MJ. Pressure
ulcer healing with a
concentrated, fortified,
collagen protein
hydrolysate supplement: a
randomized controlled
trial. Adv Skin Wound Care.
2006;19(2):92-6.
Evidence Level = II
Randomized clinical
trial
Determine level of
arginine
supplementation
that is orally and
metabolically
tolerated and
effective in
enhancing immune
function in elderly
patients with PrU
Randomized,
prospective, doubleblind, placebocontrolled
multicenter trial
Compared PrUs
scores at 8 weeks in
long-term care
residents with PrU
given standard care
plus a concentrated,
fortified, collagen
protein hydrolysate
supplement vs.
residents given
standard care plus
placebo
Prospective, noncomparative,
observational, cohort
0 g Arg: n=10, 82 y
8.5 g Arg: n=11; 81 y
17 g Arg: n=11; 87 y
2 LCTs
4 weeks of supplementation
Arginine supplementation: 0
g, 8.5 g, 17 g
23 long-term-care
facilities in 4 states
n=89; 71 completed
study
n=56 intervention; n=33
placebo
Stage 2, 3, 4 PrU
8 week intervention
Standard care plus
concentrated, fortified,
collagen protein hydrolysate
(15 g in 45 mL unit dose,
ProStat, Medical Nutrition
USA) vs. placebo
n=9
Age=71 y; BMI=23.3
53
Results
Not possible to draw a firm
conclusion on the effect of enteral
and parenteral nutrition on the
prevention and treatment of PrU
Dietary supplementation may
prevent PrU in acutely ill older
people, more research is needed to
identify effective dietary
interventions
%IBW, serum albumin levels did not
change over the 4-week
supplementation period
Total energy and protein intake and
% weight change were not different
among Arg supplementation groups
Significant increase in plasma
Arginine with supplementation
Good oral and metabolic tolerance
Arginine supplementation did not
enhance proliferative responses
4 weeks of Arginine supplementation
resulted in significant (p<0.05)
decrease in lymphocyte proliferation
in supplement groups 17 g vs. 8.5 g
75 PrU in intervention & 33 in control
group
After 8 weeks:
PUSH scores decreased for all
patients; twice rate of healing in
intervention group vs. control
Significantly better PUSH scores in
intervention group vs. placebo (3.55
vs. 3.22, p<0.05)
Randomization process;
group differences at
baseline
Data variability & analysis
Convenience sample
No information on
patient medical status,
nutrient & other medical
intervention data
Study design
Type of Study
study
Evidence Level = V
Investigate the
micronutrient status,
food intake and role
of ONS in elderly
patients with chronic
low-limb ulcers and
PrU
Identify nutritional
risk factors of
delayed wound
healing
Systematic review
Systematically review
the evidence
examining
interventions to
prevent PrU
Case studies
Examined effect of
oxandrolone and
glutamine of PrU
healing in spinal cord
injury patients with
PrU
Randomized clinical
trial
Determine if arginine
supplementation
enhances in vitro and
in vivo measures of
immune function in
nursing home elderly
with PrU
Sample
Intervention(s)
Results
31-95% of energy intake
ONS were willingly consumed (2.4
units/d), meeting 35% of energy &
40% of protein requirements
Selenium & zinc requirements were
not met
Complete wound healing achieved in
all cases; 7 of 9 having straight
healing
5 RCTs targeted
impaired nutrition
interventions
1475 patients: 66% in
acute care, 34% in LTC
varied
PrU prevention
Study designs,
randomization, blinding,
interventions
Wound healing
Study design
Sample size
4 week Arginine
supplementation
8.5 g L-Arginine
Isonitrogenous supplement
(22.4 g Promod containing
0.4 g arginine)
3 servings/d of 50 mL each
10 week follow-up
No information on PrU
healing, incidence
54
Type of Study
Sample
Intervention(s)
Evidence Level = II
Systematic review,
Meta-analysis
Determine effect of
enteral nutritional
support on PrU
incidence, healing
QOL, complications,
mortality, nutritional
status
ONSTube Feeding
PrU incidence
Healing
QOL
Complications
Mortality
Dietary intake
Nutritional status
Evidence Level = I
Results
groups at week 10 vs. week 4 &
baseline; Arg-suppl group maintained
while isonitrogenous group
decreased lymphocyte proliferation
response
No significant change in NO between
or within group
No significant diff in BMI. body
weight, prealbumin, MNA between
groups at weeks 4 and 10
ONS (200-500 kcal, high protein,
consumed for 2 to 26 weeks)
associated with significantly lower
incidence (25% lower) of PrU in at
risk patients vs. routine care. Metaanalysis of all 5 RCTs showed
significantly lower incidence of PrU
development in at-risk patients vs.
routine care. Compared to standard
formulas, disease specific products
(high-protein) use exhibited trend
towards improved healing of existing
PrU.
Quality of evidence is
"poor", need additional
research to substantiate
findings
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Randomized clinical
trial
Investigate whether
postoperative
nutrition of head and
neck cancer patients
using an arginineenhanced formula
could improve
nutritional variables
as well as clinical
outcomes
55
Results
Limitations
Not PrU
Pompeo M.
Misconceptions about
protein requirements for
wound healing: results of a
prospective study. Ostomy
Wound Manage.
2007;53(8):30
Type of Study
Prospective,
descriptive study
Evaluate the
hypothesis that
wound patients
require higher levels
of protein than is
commonly
recommended & that
wound size and
severity affect
protein requirements
Sample
Intervention(s)
PUSH score
Protein status
56
Results
Length of postoperative stay was
better in group I than II.
47% of wound group vs. 32% in nonwound group had diabetes.
12% of wound group vs. 21% nonwound group had normal PreAlb
levels at admission.
LOS was longer for wound group vs.
non-wound group (36.9 vs. 29.7
days).
42% of wound group & 46% of nonwound group normalized &/or
increased PreAlb levels.
Feeding failure more common in
wound group
Patients improving protein status
received significantly (p=0.001)
higher dietary protein: 1.85 g/kg/d in
wound group & 1.47 g/kg/d in nonwound group.
Lower PUSH and total surface area on
admission seen in wound group that
did not improve protein status
Trend between higher wound burden
and max amount of protein provided
seen in patients whose PreAlb
improved.
Limitations
Descriptive study;
sampling
Limited information on
tube feed protocol
Type of Study
Sample
Intervention(s)
Retrospective
study
N=17, (9 females, 8
males)
Inclusion: diagnosis of
incurable malignancy,
Grade 2+ pressure ulcers
Results
Limitations
57
Non-respondent group
would have limited
ability to participate.
Primary conclusions can
be applied to
respondent group
rather than nonrespondent group.
Type of Study
Systematic Review
Sample
Intervention(s)
Systematic review
58
Results
Limitations
significantly correlated
with generalized pain
intensity on VAS (r=.59,
p<.1) & generalized pain
intensity assessed by FRS
(r=.53, p<.1). Localized
VAS significantly
correlated with max PrU
stage (r=0.37, p<.01).
Those receiving analgesics
for PrU pain reported
significantly greater than
those not receiving
analgesics (p<0.05) &
those receiving narcotics
reported significantly
greater pain than those
not receiving narcotics
(.02). Patients with PrU
experience pain, & many
perceive it as severe, &
most did not receive
analgesics for PrU pain.
Stage IV PrU subjects had
greater pain than those
with lower stage PrU. Was
high degree of agreement
between FRS and VAS.
Is strong evidence to
support a positive effect
of topical (dia)morphine
for painful PrUs. Is some
evidence to support
positive effect of
benzydamine gel and
Eutectic Mixture of Local
Anaesthetic (EMLA)
cream. The reviewers
recommend to consider
both benzydamine gel and
EMLA as specific relieving
interventions in patients
with severe pressure
related pain, e.g., in
preparation of wound
Type of Study
Sample
Intervention(s)
59
Results
Limitations
Recommend using
MPQ, VAS & FRS to
diagnose PrU pain, using
MS gel, benzydamine
gel or EMLA for pain
relief.
Type of Study
Sample
Intervention(s)
Results
Limitations
wounds.
Flock P. Pilot study to
determine the effectiveness
of diamorphine gel to control
pressure ulcer pain. J Pain
Symptom Manage.
2003;25(6):547-54.
Evidence Level = II
Randomized,
double-blind,
placebocontrolled
crossover pilot
trial. Patients
served as own
controls.
Franks PJ Winterberg H,
Moffatt CJ. (2002). Healthrelated quality of life and
pressure ulceration
assessment inpatients treated
in the community. Wound
Rep Regen. 10:133-40.
Random assignment to 1 of 2
treatment sequences: 3 days of
IntraSite gel followed by 3 days of
diamorphine gel, or vice versa.
IntraSite gel is ready-mixed HDG &
used as placebo. Diamorphine gel
(0.1% weight to weight mixture) was
mixed with IntraSite gel. Gels applied
1x/day & covered with standard
dressing. All patients had pressure
relieving cushions & mattresses &
encouraged to change positions
frequently. Pre-trial, PrU location, size
& stage were documented.
60
Type of Study
Secondary data
analyses as part of
a cross-sectional
study (reanalysis
of Dallam et al.
study)
Sample
Evidence Level = V
Intervention(s)
Descriptive
Pressure ulcers
61
Results
give informed consent and
some were not able to
complete the SF-36.
The study demonstrated
the utility of the FRS in
hospitalized elderly
patients who have more
cognitive impairment and
sensory deficits relative to
a community population.
The study also established
that results obtained from
the FRS can be
transformed nonlinearly
to VAS with a high degree
of reliability.
After 24 hours of
treatment, 29 of 30 PrUs
were pain free with
complete relief achieved
in all 30 by 48 hours.
Limitations
Type of Study
Sample
Intervention(s)
Results
Limitations
Evidence Level = V
Prentice WM, Roth LJ, Kelly P.
Topical benzydamine cream
and the relief of pressure
pain. Palliat Med.
2004;18(6):520-4.
Randomized,
double-blind,
placebocontrolled trial
Evidence Level = I
Exploratory,
descriptive and
cross-sectional
quantitative study
62
Type of Study
Prospective Crosssectional
Intervention(s)
Sample
Descriptive,
comparative study
63
Results
may contribute to
breaking the myth of the
absence of pain in
pressure ulcers,
permitting healthcare
workers to understand
this problem in order to
improve pain
management for patients
with pressure ulcers.
28% had wound pain
unrelated to dressing
change, average wound
duration 4.1 months
(range 1-15 months), near
SSD in that those with
Stage III-IV PrU to
experience >pain (35.9%)
than other (16.7%).
28 (87.5%) of patients
reported pain at dressing
change & 27 (84.4%)
experienced pain at rest,
& 4 (12.5%) reported no
pain. Of the 28 with pain,
75% rated it mild to
discomforting, 18% as
horrible or excruciating.
12 reported pain as
continuous, occurring at
rest & dressing change.
92% of subjects with Stage
II PrU reported pain, 100%
with Stage III had pain,
and 75% of Stage IV
reported pain. Only 2 (6%)
of subjects had received
pain med for their PrU
pain. Patients with Stage
Limitations
Small sample,
correlational design, no
causal direction can be
ascertained, sample not
homogenous with mix
of wounds.
Type of Study
Randomized,
double-blind,
placebocontrolled,
crossover pilot
study
Evidence Level = I
Sample
Intervention(s)
Results
II, III & IV PrU experience
pain which is often severe
& constant. The number
of word descriptors used
to describe pain directly
in relation to PrU Stage.
Patients with Stage III-IV
reported more constant
pain, Stage II more
transient pain. Individual
pain assessment should be
included as a standard
part of the initial
assessment of PrUs, &
therefore be assessed on a
regular basis, not just at
dressing change or other
manipulations of the
wound. P. 119.
All patients reported
lower VAS scores with
MSO4 compared to
placebo & no local or
systemic adverse effects
attributable to MSO4 (47
v. 15). NSD inpatients use
of rescue analgesics
during 2 treatment arms.
Study suggests MS added
topically is effective in
producing local analgesia,
is well tolerated, & no
negative effects.
Limitations
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Qualitative pilot
study, Heideggarian
phenomenology
with interpretative
phenomenological
64
Results
Limitations
Type of Study
Sample
analysis.
Meta-analysis,
Intervention(s)
65
Results
Limitations
Type of Study
Descriptive
Case series
Sample
Inclusion: persistent
pain, venous leg ulcer,
appropriate statistical
analyses.
11 patients with painful
leg ulcers
Descriptive
phenomenological
Preliminary
N=32 consecutive
Intervention(s)
Results
Limitations
on 100 mm scale.
66
Measurement of
patients pain is
subjective & subject to
interpretation &
influence of other
uncontrolled variables.
Uni-dimensional rating
scales, e.g., VAS, fail to
reflect multiple
dimensions of pain. Pain
rating differs with time of
day, stress, season, and
mood.
18 of the 32 patients
Type of Study
Sample
Intervention(s)
V, Tarnovskaya A, Brem H.
Pathogenesis and treatment
of pain in patients with
chronic wounds. Surg Tech
Int. 2003;11:168-79.
exploratory study
Results
Limitations
(VAS)
experienced pain. On a
scale of 0-10, the average
pain experience by these
patients was 5.08. Pain is
decreased when an
integrated wound
management team is
involved in treatment,
based on results
tabulated from the forms
of patients with multiple
pain scores. The
decrease in pain was
generally correlated with
a decrease in wound
surface area and an
increase in the patients
MFIM. The correlation
implies that pain
management facilitates
healing of the wound and
healing results in less
pain. Pain assessment
form is unbiased,
accurate method that
should be used to
measure change of pain
in patients with chronic
wounds. Study had a
small sample size.
Subjects age not
mentioned.
Modified Functional
Independence
Measurement (MFIM)
indicates a patients
ability to perform basic
self-care and locomotion,
and is measured on a
scale of 0-70, with 70
signifying complete
independence and 0
signifying complete
dependence.
Note: MFIM form and
Pain Assessment form are
included in the article.
Gottrup F, Jrgensen B,
Karlsmark T, Sibbald RG,
Rimdeika R, Harding K, et al.
Less pain with Biatain-Ibu:
initial findings from a
randomised, controlled,
double-blind clinical
investigation on painful
venous leg ulcers. Int Wound
J. 2007;4 Suppl 1:24-34.
Double-blind RCT
N=122
Ibuprofen Group=62
Control=70
Venous ulcers
67
Patients in ibuprofen
group experienced
significantly > relief from
persistent pain (p=.0003)
days 1-5; wound pain
intensity significantly in
ibuprofen group days 1-5
(p<.0003), 6.8 baseline to
4.1 (40%).
Dressing change pain
intensity in ibuprofen
group on introduction of
Type of Study
Case series
Randomized,
prospective
parallel-group
study.
Heideggerian
phenomenology.
Inclusion criteria:
>65 years, Stage IIIIV PrU > month,
able to consent.
Sample
Intervention(s)
Inclusion: adults,
chronic wounds
N=43
EMLA Group=22
Control Group=21
Inclusion: venous leg
ulcer, systolic ankle
pressure >80mmHg
Exclusion: ulcers <1cm2,
or >50cm2 , history of
sensitivity to local
amide type anesthetics,
treatment with EMLA
cream during previous
month, ongoing local
antibiotic or proteolytic
enzyme treatments.
N=8 (7 from UK & 1
from Belgium) from 4
centers & with 4 data
collectors
68
Results
non-ibuprofen dressing
(days 43-47). Sig diff pain
intensity (p<.05) at
dressing removal for
ibuprofen group from
baseline NBS values of
0.3 to 0.9 (300%)
compared to constant
levels in non-ibuprofen
group with average NBS
of 2.0 baseline. No diff in
dressing change pain
days 1-5.
On 1st day, lowest scores
were 1-10 with all
Patients having overall
score of 75 (average 6.8).
Overall score 29 on day
10. Level of pain reduced
23% overall following 1st
application & by 61% on
final application of
dressing.
Treatment with EMLA
cream significantly pain
from cleansing &
frequency of postcleansing pain. Analgesic
effect remained
unchanged with
successive treatments.
NSSD in local reactions or
adverse effects on
granulation tissue, ulcer
area or bacterial flora
between groups.
Limitations
No statistical analysis
used.
Treatment times
insufficient for healing to
occur.
Multiple interviewers;
translation of stories;
obtaining sample due to
age limitation presence
of comorbidities; many
had had flap repair;
Type of Study
Sample
Intervention(s)
Exclusion criteria:
SCI
Single-blinded cross
over study
N=10
Inclusion: adult, painful
venous leg ulcer >8
week duration, received
compression therapy
for at least 4 week prior
to study
Case review
Exclusion: presence of
clinical infection or
cellulitis of peri-ulcer
skin, disease that
interferes with healing.
69
Pain relief
Results
Limitations
Observation periods
were short. Application
of gel to open wound is
difficult, especially with
much exudates, & much
of drug may be flushed
away. Need to identify
how morphine absorbed
through healthy skin, as
is poor thru intact
epidermis, but when
epidermis removed,
bioavailability is 75%. Is
morphine absorbed
systemically rather than
locally?
Type of Study
Sample
Intervention(s)
Heideggerian
hermeneutical
phenomenology
with PrUs
Spiegelbergs
phenomenological
method
descriptive,
qualitative
N=8, Non-probability,
purposive sample, 4
with PrU & 4 with
previous PrU (Stage IIIV). Four had SCI & 5
had surgical flap
reconstruction; 2 had
MS, 1 was bipolar,
alcoholic, & 1
degenerative
neuromuscular
disorder. Males=7,
female=1, mean age
35.7 year, range 27-52
year. 6 of 8 had
multiple PrU, all 4
current Patients with
PrU were Stage IV
Randomized,
double-blind,
placebo-controlled
study
N=69;
EMLA group=36
Placebo Group=33
70
Limitations
receptors become
activated within hours.
Morphine & diamorphine
appear to do equally well.
Three consecutive
patterns and 8 themes
identified.
Results
7 themes emerged:
perceived etiology of PrU,
life impact & changes
(physical, financial &
social), psycho-spiritual
impact (body image
changes, struggle with
stereotypes,
desire/struggle for
control & independence,
spiritual impact), extreme
painfulness with PrU
(pain Intensity &
duration, analgesic use),
need for knowledge &
understanding
(knowledge of
prevention, physiologic
processes & lack of
knowledge), need for &
effect of numerous
stressful treatments (selfcare, treatment regimens
& multiple surgeries,
complications, length of
healing time), & grieving
process (denial,
depression, anger,
bargaining, acceptance).
NSD between groups on
demographics. EMLA
cream sig VAS pain
scores for debridement
Limited to Caucasians,
young or middle age, in
Midwest area of US.
Need replication in other
ethnic groups & urban
areas. Not followed
longitudinally.
Type of Study
mechanical debridement of
venous leg ulcers: a doubleblind, placebo-controlled
study. J Am Acad Dermatol.
1999;40(2 Pt 1):208-13.
Comparative open
prospective parallel
& blockrandomized study.
Total 18 month
study period.
Sample
Intervention(s)
N=619
Inclusion: 18 or >, not
pregnant or lactating,
chronic wound with
delayed healing & modhigh exudates
Exclusion: depth <0.5cm
N=10, Purposeful
sampling of acute care
patients with a PrU, 7
female & 3 male, 30-90
years of age. 8 had preexisting PrU & 2 PrU
developed in hospital.
71
Limitations
assessments.
8% were PrUs.
Phenomenological,
qualitative study
Results
Limited to 10 subjects.
Type of Study
Open comparative
prospective blockrandomized design.
Pilot study.
Vast majority
venous ulcers.
Sample
Intervention(s)
N=24
Pain intensity measured bid on 10point NBS (Numeric Box Scale), pain
relief on 5-point VRS & diary with
am & pm recordings.
Results
Langemo, & Szor.
Emotions of frustration,
depression, anger & rage
also reported. The pain
experience from a PrU
permeates their
existence.
For ibuprofen group,
additive am scores sig
(p=.04) & pm scores sig
(p=.02), sig correlation
between am & pm scores
(r=.85, p<.0001), & with
pooled am & pm scores
(p=.0217). Sig in acute
wound pain intensity
after last dressing
removal (p=.04).
Sig in ulcer area in
ibuprofen group (p=0.05)
& ibuprofen group also
had > granulation tissue.
Limitations
Exclusion: known
contraindication or
allergy to ibuprofen or
NSAID, females
pregnant or lactating,
ulcer down to tendon,
muscle or bone, or
symptoms of bacterial
burden.
Qualitative semistructured
interviews
Inclusion criteria:
Exclusion criteria:
Ibuprofen Group=12
LBP Group=12
Purposive sample, N=23
hospitalized patients
(M=5, F=18), 33-92
years (median 78
years). Highest PrU
locations heel &
sacrum. PrU stages II-V.
72
Impossible to separate
effect of PrU from
chronic condition.
Type of Study
Pre- Post,
Prospective open
label comparative
study.
Sample
N=46
50% male, 50% female
Inclusion: heavily
exudating leg ulcer
Exclusion: sensitivity to
GFD-N, history poor
adherence, arterial
ulcer, required wound
filler on enrollment
Intervention(s)
73
Results
health care prof for
getting PrU, 8 blamed it
on comorbidities, , 3 on
poor hygiene practices or
lack of knowledge. 91%
had PrU pain, & 2 who
didnt either had neuro
condition or were
unaware of PrU. PrU
associated with pain,
fluid leakage & smell,
discomfort, & mobility
difficulties.
Mean pain VAS intensity
rating >50% for 1st clinic
dressing change
compared to pre-study
(4.7 v 23, p<.001) & on
removal (3.9 v 1.7,
p<.001). Peri-wound skin
condition better for 31%
(p=0.006). GFD-N
dressing associated with
SSD in ulcer pain with
dressing in place & during
removal. Of 46 subjects,
11% healed the ulcer &
78% improved in 4 or <
weeks.
GFD-N was safe, effective
& convenient for wound
healing, exudates
management,
pain/comfort & ease of
use.
Limitations
Type of Study
Sample
Intervention(s)
Evaluation of 4
alternating pressure
air cushions (APAC).
10 healthy volunteers
None
Review of published
papers on pressure
reducing and
pressure relieving
mattresses
Evaluation of 29
seating cushions
and sheepskin.
20 healthy volunteers
None
Repeated measures
of 2 sitting push-up
protocol
20 normal, 20
paraplegic and 20
tetraplegic subjects
Multicenter RCT,
open, fixed sample,
parallel-group trial
11 hospital based
research centers in UK
Results
Limitations
Healthy subjects. No
patients with PrUs. No
follow-up.
74
Healthy subjects. No
patients with PrUs. No
follow-up.
No statistically significant
difference in proportions
of patient developing
PrU, healing time.
Reduced LOS on mattress
resulted in some cost
savings
No length of follow-up
given.
Type of Study
Sample
Intervention(s)
Retrospective
664 NH residents
3 mattress groups
New product
evaluation, 3month study period
Unblinded,
randomized,
prospective trial
Results
Limited follow-up
No information about
number of subjects, lack
of sample size.
1-experimental devices
2-standard devices
Development of nonblanching
erythema
Experimental device
proved better for
preventing blanching
erythema but not
significant for nonblanching erythema
75
Limitations
Type of Study
Sample
Intervention(s)
Results
Limitations
Pilot project to
develop a decision
tree for support
surface selection
Care. 2003;16(6):317-27.
Warren JB, Yoder LH, Young
McCaughan S. Development
of a decision tree for support
surfaces: a tool for nursing.
Medsurg Nurs. 1999;8(4):23945.
Type of Study
Sample
Intervention(s)
Observational study
NA
A convenience sample
of 54 healthy children
from the community
ranging in age from
infancy through 18
years was selected.
The total sample size
consisted of 54
children: 24 girls and 30
boys. Their ages ranged
from 3 months to 16
years. Their weight
ranged from 6.43 kg to
98.1 kg, and their
height
ranged from 59.5 cm to
185 cm
NA
Descriptive Study
design
Results
Of the four children who
used this system, no child
experienced
skin damage while being
nursed on theTransair
Pediatric Mattress.
The responses received in
each case were entirely
positive.
The standard hospital
mattress yielded the
highest interface
pressures.
The Delta Foam overlay
alone or in combination
with the Gel-E-Donut
pillow produced the
lowest occipital pressures
in all age groups.
The Delta foam overlay
produced comparable
pressures to the Efica lowair-loss bed when
measuring the coccyx and
heel interface pressures.
The Delta Foam overlay
76
Limitations
Very small sample size
No control group
Non Randomized
Type of Study
Sample
Intervention(s)
Results
Limitations
alone or in combination
with the Gel-E-Donut
pillow is a cost effective
and therapeutic choice for
pressure redistribution as
demonstrated in this study
of healthy children.
Observational study
13 healthy children
ranging in age from 10
weeks to 13.5 years
were selected for this
study.
The mean age was
7years 3 months.
NA
77
Small sample
No control group
No randomization
Type of Study
Sample
Intervention(s)
Results
changes with increasing
age from the occipital area
to the sacral area.
Therefore different
pressure redistribution
considerations are
necessary in treating
pediatric patients than in
managing pressure under
adults.
78
Limitations
Table 6. Cleansing
Direct Evidence
References
Type of Study
Sample
Intervention(s)
Subjects divided
into 2 groups:
Normal Saline (NS)
group April 2000March 2002,
cleanser (CL) group
April 2001-March
2002. No blinding
or randomization.
Descriptive study of
17 long-term care
(LTC) patients
(patients) with
stage III/IV ulcers
17 ulcers: 7 sacrum, 7
trochanter, 3 ischial
Systematic review
Reference
Type of Study
Systematic review
with
recommendations
Results
Limitations
Irrespective of stage,
healing time shorter with
pH balanced cleanser
especially in stage II
No studies compared
cleansing with no
cleansing
Sample
Intervention(s)
Results
Limitations
Evidence Level = V
Quality: Good
Also in Table 10 Infection
Moore ZEH, Cowman S.
Wound cleansing for pressure
ulcers. Cochrane Database
Syst Rev. 2005(4):CD004983.
Evidence Level = I
Quality: Strong
Indirect Evidence
79
Type of Study
Sample
Intervention(s)
2006;14(1):20-3.
Quality: Good
Systematic review
with
recommendations
Random/quasi
random
Electronic databases
Rates of infection/healing
Randomized/quasi
random
Searched electronic
databases
Objective/subjective measures of
wound infection or healing
Quality: Strong
Fernandez R, Griffiths R.
Water for wound cleansing.
Cochrane Database Syst Rev.
80
Results
cooled water is a viable
alternative (grade C).
Irrigation with povidone
iodine is recommended for
contaminated wounds
(Grade B) but no evidence
of the time it should be
left in place (Grade E).
Showering of chronic
wounds undertaken with
caution (Grade C).
Whirlpool may improve
healing rate in PrU (Grade
C). Soaking in povidoneiodine is not effective in
reducing bacterial counts
(Grade B).
Use potable water for
irrigation when saline
unavailable; run tap for 15
sec. Boiled and cooled
water effective in absence
of saline or potable water.
Same recommendations as
above for povidone iodine
in contaminated wounds
(B). Soaking in 1%
povidone iodine not
effective in reducing
bacterial counts (B). 13 psi
irrigation pressure
effective in reducing
infection and
inflammation in
lacerations and traumatic
wounds (B).
No difference in rates of
infection/healing between
tap water/saline in
cleansing of acute/chronic
wounds
5 trials, 3 compared
cleansing with no
cleansing, 1 compared
Limitations
Multiple types of
wounds. Recommend
reading full report at:
http://www.joannabriggs
.edu.au/pdf/BPISEng_10_
2.pdf
Method quality of
studies, more studies
needed
Type of Study
Sample
Intervention(s)
2008(1).
Quality: Strong
Results
Limitations
pool data
Systematic review
of randomized &
clinical controlled
trials
Electronic databases
In-vivo study
involving goats
Animal musculoskeletal
model, used acute
wounds, bacteria may not
be representative of what
is found in chronic
pressure wounds
Prospective
randomized trial
over 14 months
14 wounds infected-- 7 in
saline group and 7 in
water group
Quality: Fair
Svoboda SJ, Bice TG, Gooden
HA, Brooks DE, Thomas DB,
Wenke JC. Comparison of
bulb syringe and pulsed
lavage irrigation with use of a
bioluminescent
musculoskeletal wound
model. J Bone Joint Surg Am.
2006;88A(10):2167-74.
Quality: Good
Valente JH, Forti RJ,
Freundlich LF, Zandieh SO,
Crain EF. Wound irrigation in
children: saline solution or
tap water? Ann Emerg Med.
81
Wounds appeared to
contain biofilm, sample
small, 1 PrU
Type of Study
2003;41(5):609-16.
Quality: Strong
Wilson JR, Mills JG, Prather
ID, Dimitrijevich SD. A toxicity
index of skin and wound
cleansers used on in vitro
fibroblasts and keratinocytes.
Adv Skin Wound Care.
2005;18(7):373-8.
In vitro cellular
model with
fibroblasts &
keratinocytes
Sample
Intervention(s)
patients enrolled
17 cleansers and 3
liquid bath soaps
Quality: Good
82
Results
In-vitro monolayers of
normal human skin cells
(fibroblasts, keratinocytes)
are reliable models for
screening for toxicity of
cleansers
Limitations
to group, water not
tested for particulate
matter
In vitro, so difficult to
translate into pressure
ulcer wounds
Table 7. Debridement
Direct Evidence
References
Alvarez OM, FernandezObregon A, Rogers RS,
Bergamo L, Masso J, Black M.
A prospective, randomized,
comparative study of
collagenase and papain-urea
for pressure ulcer
debridement. Wounds.
2002;14(8):293-301.
Evidence Level = II
Type of Study
Sample
Intervention(s)
Prospective,
randomized,
parallel, group, tricenter, open-label,
clinical trial
18 years of age
Nonviable tissue
attached to ulcer
base
If ulcer located on
feet, must have
ABI 0.75 or
normal PVR to r/o
arterial disease
Exclusion:
Clinical signs of
infection
Cellulitis
Osteomyelitis
Inadequate
nutrition
Uncontrolled DM
Renal, hepatic,
hematological,
neurologic, or
immunological dz.
Patients on
corticosteroids,
immunosuppressive
agents, radiation or
chemo within 1 month
prior to study entry
Treatment protocol:
-If thick hard eschar is present, crosshatch with # 10 blade
-Cleanse with NS
-No forceful irrigation
-Apply study medication over entire
surface of nonviable tissue (1 x daily
using a tongue depressor (approximate
thickness of a nickel, 2 mm) (* If the
dressing dislodged or soiled, only 1
additional application of test agent
allowed)
-Apply lightly fluffed NS moistened
gauze
-Cover with dry gauze
-All subjects were placed on pressure
redistribution sleep surfaces & chair
cushions (selection was determined by
the investigational team & dependent
upon ulcer location & consistent with
the AHCPR Guidelines)
-Subjects confined to bed were
83
Adherent yellow/gray/white
slough
Edges (undermining)
Odor
Wound pain
Exudate
Peripheral tissue
Results
Limitations
-No demographical
differences between
groups
-No significant difference
(p 0.05) between groups
with respect to ulcer size
& amount of nonviable
tissue @ baseline
-Ointment application was
considered easy &
convenient
-Papain-urea ointment
was significantly more
effective (p0.0167) in
debriding at all 3 time
points
-Reduction in area of
nonviable tissue covering
wounds over time was
significantly greater
(p0.0167) for papain-urea
at all 3 evaluations
-Visual scores showed that
granulation was
significantly (p0.0167)
greater for papain-urea
- Neither were associated
with pain or discomfort
Type of Study
Sample
Intervention(s)
repositioned: q 2 hours using pillows &
foam wedges whenever possible
-Written turning schedules & diaries
were kept on all subjects
-1 investigator or CSC at each site
performed all evaluations
-If infected, infection had to be
resolved prior to enrollment
Randomized,
controlled, blinded
trial
Evidence Level = II
Burgos A, Gimenez, J,
Moreno, E, Lanberto, E, et al.
Cost, efficacy, efficiency and
tolerability of collagenase
Multi-center,
randomized, nonblind, parallel study
conducted at seven
Thirty-seven patients
were randomized using
a computer-generated
randomized list into
Daily
Induration
Edema
Erythema
Amount granulation
Amount re-epithelialization
(using surface area wound
tracings)
84
Limitations
No statistical significance
between groups, in:
Time to debride
Pain experienced
Odor
Development of
maceration
Results
No discussion on
debridement
outcomes
No discussion on
Type of Study
Sample
Intervention(s)
hospitals in Spain
blocks of 4 patients to
receive either:
1. Collagenase
ointment
(Iruxol)
2. Hydrocolloid
(Varhesive)
Inclusion:
Patients aged 55
years or older
(n=18)
-Applied once daily in a 1 to 2 mm thick
layer to the wound bed
Exclusion:
End-stage organ
disease
Localized or
systemic s/s of
infection (fever,
local erythema,
regional lymph
node swelling)
Hypersensitivity to
collagenase
Results
Indirect Measurement:
-An identification label was placed
at each ulcer margin and ulcers
were photographed according to a
standardized method at 50 cm
from the focus and the contour of
each ulcer was transferred to a
transparent acetate
Reasons for
discontinuation included,
death due to unrelated
cause (n=4), hospital
discharge (n=4) and
transfer to another
hospital (n=3), protocol
violation (n=2),
deterioration of general
patient condition (n=1)
(and for the HCD arm lack
of efficacy (n=1)
85
Limitations
standardization of
care as it pertains
to pressure
redistribution and
nutritional
interventions
No blinding
Arnell scoring not
defined
Type of Study
Sample
Intervention(s)
Results
were not statistically
significant
-After 12 weeks 83.3% of
subjects receiving
collagenase exhibited a
reduction in ulcer area, vs.
73.7% of those treated
with HCD, the difference
did not reach stat
significance
-Complete healing was
achieved in six (16.2%) of
patients, 3 in each
treatment arm
-Efficacy analyses reported
an ulcer reduction of
44.2% in the collagenase
group and 27.9% in the
HCD group
-Cost analyses between
the two group was stat
significant (p0.0001)
-Efficacy analyses showed
no stat significant
differences between the
groups
-Pain intensity was stat
significantly decreased in
those receiving
collagenase (p=0.001)
-Granulation tissue
(p0.0005) & exudates
(p 0.0005) in both
treatment groups
-1 subject in the
collagenase group
developed dermatitis and
1 in the HCD presented
with erythema and
exudates
-Treatment efficacy cost
tended to be lower in the
collagenase group than in
the HCD
-Tolerability of both
86
Limitations
Type of Study
Randomized
controlled trial
Evidence Level = II
Open, multicenter,
multinational,
parallel group,
prospective
randomized, study
Sample
Intervention(s)
Hospitalized inpatients
Stage II or IV
Exclusion:
Cardiac
arrhythmias
Use of lifemonitoring
equipment
Mechanical debridement
Same as Group 1
1 outcome measure:
- % reduction in the area of nonviable tissue during the 21 day
period (measured by Wilcoxon
Rank Sum Test)
When a patient
presented with more
than one PrU, only the
largest ulcer was
assessed as part of this
study; other ulcers were
Improved-n=5 (28%
of patients)
No - n=2 (11% of
patients)
Deterioration- n= 11
(61% of patients)
Group 2 (Whirlpool):
Improved-n=14 (58%
of patients)
No - n=1 (4% of
patients)
Deterioration- n= 9
(38% of patients)
2 outcome measure:
-Median % reduction in wound
surface area
87
Results
Limitations
Type of Study
Sample
treated with the same
randomized dressing if
considered clinically
appropriate by the
investigator
Intervention(s)
Results
Limitations
statistically significant
(p=0.03); 35% reduction in
hydrogel treated PrU
compared to 7%in the
dextranomer treated
group
- 8 (12%) of Hydrogel
treated ulcers
deteriorated and 13 (19%)
of dextranomer treated
ulcer deteriorated
-The only reported
dressing related adverse
event was in the
dextranomer treated
group and that was pain
with dressing application
-Assessments at days 7,14
& 21 found the amorphous
hydrogel to be easier to
apply and remove than the
dextranomer paste and
was associated with less
pain
Patient outcomes:
Hydrogel (n=67)
-53 (79%) completed
study; 14 (21%) were
withdrawn; 1 Adverse
incident, 2 died and 11 lost
to follow-up
Dextranomer paste (n=68)
-43 (63%) ) completed
study; 25 (37%) were
withdrawn; 4 Adverse
events, 2 died and 19 were
lost to follow-up
Randomized,
double-blind,
controlled trial
Grade IV PrU
Group A; (n=11)
Enzyme in KY Jelly
Administered 1x daily
88
Group A:
-Mean (11.8 days); SD 2.9
Enzyme in KY Jelly Group
Type of Study
Care. 1996;5(7):310-1.
Evidence Level = II
Matzen S, Peschardt A,
Alsbjorn B. A new amorphous
hydrocolloid for the
treatment of pressure sores:
a randomised controlled
study. Scand J Plast Reconstr
Surg Hand Surg.
1999;33(1):13-5.
Evidence Level= II
Also in Table 9 Dressings
Randomized,
controlled study
Sample
Intervention(s)
Treatment with
Streptokinase
/streptodornase
(Enzyme) within 4
weeks
Terminally ill
Unable to consent
1 x daily
Thin film
Inclusion:
Stage III & IV
PrUs
Non-infected
Sacral &
trochanteric
Exclusion:
Location other
than sacral or
trochanteric
Patients with
diseases or
taking drugs
known to impair
healing
Results
Limitations
Group B:
-Mean (8.1 days); SD 1.8,
KY Jelly alone
No statistical significance
between groups
89
Type of Study
Sample
Intervention(s)
Results
Limitations
the wounds
- No statistically significant
difference between the
two treatment arms
related to odor, pain
during treatment, comfort
during use, nor length of
time dressings required
(days)
-(20 patients in total
withdrew); 9 patients in
the hydrogel group
withdrew (because of
other illness (n=5); death
(n=2); missing
appointment (n=1) and a
wish to discontinue
participation (n=1)); 11
patients in the control arm
withdrew; because of
insufficient effect of
treatment (n=6); other
illness (n=3); death (n=1);
wish to discontinue
participation (n=1)
-Results of intent to treat
population was analyzed
Prospective,
Randomized, trial
90
1 outcome parameter:
-Complete healing
2 outcome parameter:
-Weeks required to achieve
healing
Type of Study
Evidence Level = II
(Examined healing and cost,
not debridement)
Sample
Intervention(s)
the heel
Exclusion:
Life expectancy
6 months
Collagenase-containing ointment
(Novuxol) (n=12)
Cleanse with NS
Once daily ointment
application
Cover with paraffin gauze
(Jelonet)
Absorbent gauze
Results
Limitations
-Number of treatment
failures not discussed
Prospective study
10 nursing home
residents with Stage II
(n=3) and Stage III (n=7)
PrUs that had failed to
heal during a 3-month
period.
91
Type of Study
Prospective,
randomized,
double-blind
Sample
N=135 subjects
Inclusion:
If several PrUs,
worst one chosen
Between 2-14.5
cm diameter (to
allow photo
assessment)
Exclusion:
Drug or ETOH
dependence
h/o
hypersensitivity to
collagenase or
F/DNAse
Planned co-
Intervention(s)
Collagenase (n=66)
2x/day
2x/day
92
Results
No statistical significance
between groups
Limitations
warranted.
-Pre-established scales
developed specifically
for this evaluation were
used in this instrument,
but formal reliability &
validity testing was not
performed.
-Retrospective review of
the medical chart for
the 3 month historical
control presents
limitations.
-Although wound
measurements,
treatment regimes, &
nursing notes provided
useful information for
control data
inexpensively, the
historical perspective
lacks direct comparison
of placebo & test
articles between
subjects
-Physicians selected
support surface &
turning intervals ( no
standardization)
-Reliability of measures
-Potential bias
Type of Study
Sample
Intervention(s)
Results
Limitations
Maggot treatment
Conventional Treatment
% Necrotic wounds
debrided (MDT 80%;
vs. Conventional
48%)
Weeks to 50%
debridement (MDT
1.4 vs. Conventional
4)
Weeks to 100%
debridement (MDT 8
vs. 17)
in % granulation
13% vs. 3.3%)
Average time to
complete healing
(MDT 12 weeks vs.
13.4 weeks)
% Healed (MDT 39% vs.
21%)
Results
Limitations
A multiple regression
model was fitted with
-Retrospective study
with historical
medication with
(antiseptics,
antibiotics,
occlusive dressing,
hydrogels or
HCDs)
Location not
permitting parallel
positioning of
reference scale
Clinical series,
retrospective
analysis
Convenience sample
(N=67 subjects; with 92
PrUs); initially cohort of
103 subjects
Inclusion:
Wounds with
complex nonplanar topography
Wounds
photographed
without scale
markers
f/u 2 weeks
Exclusion:
Underlying
osteomyelitis
Rapidly advancing
infection
Weak
methodology
Extremely limited
access to
treatment
MDT patient
characteristics (SCI
(p0.05)
DM (P0.05)
(favored
Conventional
treatment)
No description of
Conventional
treatment.
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Retrospective with
historical control
93
Type of Study
Sample
Intervention(s)
Inclusion:
Patients whose
wounds were
treated with
Versajet by the
Plastic Surgery
Department in
2003
Patients whose
wounds were
treated with
conventional
sharp
debridement
(scalpel, curette
and electro
cautery) by the
senior surgeon in
2002
Acute and
chronic wounds
Results
Limitations
unmatched controls
-Versajet 51% acute
wounds & 49% chronic;
Conventional treatment
36% acute & 64%
chronic
-Median wound area
was 88 cm2 in Versajet
Group compared to 213
cm2 in the Conventional
Group (p=0.016)
Exclusion:
Wounds treated with
debridement methods
other than scalpel,
curette, electro cautery
or Versajet
94
Type of Study
(Not specified by
authors)
Non-randomized
trial with
convenience
sampling
Sample
N= 469 hospitalized
patients with chronic
vascular leg ulcers in
Italy; 142 treated with
Versajet Hydrosurgery
System & 327 treated
with moist dressings
(Control)
Inclusion:
Chronic vascular
leg ulcer (e.g.
Arterial, venous,
mixed etiology,
vasculitis, posttraumatic,
iatrogenic,
microangiopathy)
> 70% of ulcer
surface covered
by necrotic tissue
or thick fibrin
slough with or
without exudates
Presence of
hypertrophic
granulation tissue
Exposed tendon or bone
Intervention(s)
Outcomes Measured:
-Time to complete debridement
-Effect on bacterial burden
-Procedure-related pain with Visual
Analogue Scale
-Bleeding complications
Patients were followed until
wound closure
The effects of the 2 debriding
methods were followed in 3
patients who had large bilateral
ulcers (1 ulcer treated with
Hydrosurgical device & the other
the control). Before treatment &
after 24 & 48 hours of treatment
2ml of exudates were collected
and the levels of IL-I, IL-6, TNF-,
ICAM-1, VCAM-1, MMP-9, IL-10
were measured
Results
chronic (64%) and PrUs
(32%)
Hydrosurgical Group:
-In 108 patients, 1
operative procedure was
sufficient to achieve an
adequately debrided
wound bed; 2 procedures
were required in 27 cases
& 3 procedures in 7 cases.
-Average time to achieve
complete ulcer
debridement wound bed
was 1.3 0.6 days,
compared to 4.3 3.9
days with the control
group
Hospitalization reduced
by a mean of 3 days
Bacterial burden from
106 to 103
-MD rated the patients
pain levels VAS 4.3 . 9
;(87.8% of patients found
the pain to be comparable
to that of cleansing with
NS and gauze); only 10.5%
considered the procedure
painful and required local
anesthesia
-Healing rate 82%
-Minor bleeding stopped
spontaneously
-Patient satisfaction score
2.8 0.1
Control Group:
-VAS score rated by MD or
Nurse 5.3 2.1; none of
the patients required
general, nor local
anesthesia
- Minor bleeding stopped
-Healing rate 88%
95
Limitations
-Non-randomized
-? MD & Nurses rated
pain for the patients
-Pre & post treatment
bacterial levels not
provided for control
arm
-No statistical
comparisons
Type of Study
Randomized,
prospective,
double-blind,
multi-center trial
Concurrently,
controlled ,
prospective
parallel pilot study
(nonrandomized)
Sample
Intervention(s)
96
Results
Limitations
Type of Study
Sample
Intervention(s)
Inclusion:
Ulcers > 3
months duration
Ulcers refractory
to conventional
treatment
Ulcers with
absent
granulation tissue
or the presence
of nonviable
tissue
Ulcers containing
yellow/white
slough with or
without
fibrous/scar
tissue
Ulcers with
copious amount
of exudates
Venous disease
confirmed
clinically and/or
by color flow
duplex imaging
(CDI)
No evidence of
peripheral
vascular disease,
either on clinical
97
Results
Limitations
variability in response.
-The Study group at
baseline had no
granulation tissue and
presented with slough,
while the control at
baseline had wound
beds with 15-20%
granulation and no
slough, nor non-viable
tissue
Type of Study
Sample
Intervention(s)
examination or
on CDI
Exclusion:
ABPI < 0.8
Patients with
small (< 2.5 cm2 )
or very large
(>100 cm2 )
Ulcers which are
clinically infected
with or without
microbiological
confirmation
Ulcers associated
with mixed
etiology (e.g.
Arterio-venous
ulcers)
Ulcers secondary
to systemic
causes such as
diabetes mellitus,
connective tissue
diseases (e.g.
Rheumatoid
arthritis) and
metabolic
diseases
Suspicion of
malignancy
within the ulcer
Patients with concurrent
unrelated malignancy
98
Results
Limitations
Table 8. Dressings
References
Amione P, Ricci E, Topo F, Izzo
L, Pirovano R, Rega V, et al.
Comparison of Allevyn
Adhesive and Biatain
Adhesive in the management
of pressure ulcers. J Wound
Care. 2005;14(8 (Print)):36570.
Brown-Etris M, Milne C,
Orsted H, Gates JL, Netsch D,
Punchello M, et al. A
prospective, randomized,
multisite clinical evaluation of
a transparent absorbent
acrylic dressing and a
hydrocolloid dressing in the
management of Stage II and
shallow Stage III pressure
ulcers. Adv Skin Wound Care.
2008;21(4):169-74.
Type of Study
Sample
Intervention(s)
Prospective
multicenter study
to examine the
delamination of
dressings (defined
as dressing falling
apart during wear
or removal or
presence of
dressing residue in
ulcer)
Retro
Prospective
randomized
comparative
multisite clinical
evaluation.
A total of 72 patients
with stage II and shallow
stage III, minimally
draining pressure ulcer
were enrolled in the
study. 35 patients
received the Tegaderm
absorbent Clear Acrylic
Dressing (TAAD), and 37
received the hydrocolloid
dressing.
Evidence Level = I
99
Results
Limitations
The majority of
investigators assessment
favored the TAAD.
Consideration given
included the ability to
center dressings over the
ulcer (p = .005), ability to
assess the ulcer before
(p<.001) and after (p<.00)
absorption, barrier
properties (p=.039),
patient comfort during
removal (p<.001), overall
patient comfort (p<.001),
conformability before
(p=.026) and after (p=.001)
absorption, ease of
removal (p<.001), residue
Type of Study
Sample
Intervention(s)
Results
in the wound (p=.002),
residue on peri-wound
skin (p<.001), and odor
after absorption (p=.016).
Overall satisfaction
favored the TAAD
(p<.001), and a high value
was placed on its
transparent feature (p<
.001). Mean (SD) wear
time for the TAAD was 5.7
(2.55) days compared with
4.7 (2.29) days for the HD
(p=.086). This one day
difference in wear time
was clinically noticeable by
the investigators (p=.086).
Wound closer for the 2
dressing groups was nearly
identical (p=.9627).
Clinical evaluation
70-day evaluation of
18 ulcers on 13 elderly
subjects with stage 1, II,
and III pressure ulcers.
The mean length of time
these ulcers had been
present prior
to the trial dressing was
144 days with 50% of the
ulcers [n - 9)
present for 75 days or
longer.
Physicians selected
patients for the study.
Inclusion:
4 weeks duration of
wound; therapy adjusted
based on severity of
symptoms and course of
healing.
No exclusion criteria
100
Limitations
Type of Study
Sample
Intervention(s)
Wound odor
Portion of necrotic tissue
Portion of fibrous adhesion
Wound status = healed, improved,
unchanged aggravated
Cosmetic result = excellent, good,
moderate, unsatisfactory
Compliance with therapy = much
better, better, equal or worse
Results
Limitations
No differences in
healing time were
detected between
collagen and
hydrocolloid. Collagen
treatment was more
expensive than
hydrocolloid treatment.
Stratification of initial
ulcer depth or stage
should be considered.
Randomized,
single-blind,
controlled
65 patients-residents
with stage II or III
pressure ulcers: 35 were
allocated to topical
collagen dressing and 30
were allocated to topical
hydrocolloid e.
Evidence Level = II
101
Type of Study
Sample
Cost-effectiveness
study.
Prospective
random
assignment to
Treatment groups
Intervention(s)
24 males
21 had complete SCI 4
were incomplete injury
Location of ulcer
Rate of healing (cm2 of surface
area/days to heal), healing time to
epithelialization
and treatment time
Healing time was computed at
discharge in nonhealed wounds by
subtracted by current size of the
ulcer from the baseline
Sacral ulcers
6 in control
7 in treatment
Ischial ulcers
3 in control
102
Results
=.409) in time to complete
healing between collagen
and hydrocolloid
treatment.
There were no significant
differences between
collagen for any primary
and secondary efficacy
endpoint. Baseline
measures of ulcer stage,
depth, duration, and area
were only covariates
associated with complete
healing within 8 weeks
(p<.10). only ulcer depth
(odd ratio = 0.56, 95% CI =
0.38-.81, p =.002)
remained a significant
predictor of complete
healing within 8 weeks.
Hydrocolloid was the most
cost effective treatment. It
was approximately 50%
more cost-effective than
gauze. Comparing cost
effectiveness of two
modern hydrocolloids,
Granuflex was 50% more
cost effective than
Comfeel.
Limitations
No information about
clinical effectiveness at
all. *
Type of Study
Sample
Intervention(s)
Results
Limitations
6 in treatment
Heel ulcers
2 in control
6 in treatment
Trochanter
4 in control
3 in treatment
Iliac crest
4 in control
0 in treatment
Knee
2 in control
1 in treatment
Head of fibula
2 in control
0 in treatment
Lateral malleolus
2 in treatment
0 in control
Dorsal foot
0 in treatment
1 in control
Kloth LC, Berman JE, DumitMinkel S, Sutton CH, Papanek
PE, Wurzel J. Effects of a
normothermic dressing on
pressure ulcer healing. Adv
Skin Wound Care.
2000;13(2):69-74.
4 weeks
Surface area
Prospective,
randomized
VA and 7 LYC
40 inpatients with 43
Stage II and IV PrU
Between 3 11 weeks of
treatment
Wound healing
No differences initial
wound surface area
Length of time wounds
treated considered the
NNWT was significantly
better
Matzen S, Peschardt A,
Randomized
Hydrogel 17
Time of healing
103
Type of Study
Sample
Intervention(s)
control study
hydrogel v wet
saline gauze
Wet saline 15
Wounds sacrum or
trochanter areas
Stage II-IV non-infected
Measurements 1X/week
8 week, open
randomized.
multicenter
controlled study
38 residents
18 randomized to soft
silicone dressing, 20 in
the hydropolymer
dressing
Randomized open
label mutecentered parallel
group
Results
Limitations
dbridement than
hydrogel
Rate of healing was
significantly better
hydrogel
Evidence Level = II
Meaume S, Van De
Looverbosch D, Heyman H,
Romanelli M, Ciangherotti A,
Charpin S. A study to
compare a new self-adherent
soft silicone dressing with a
self-adherent polymer
dressing in stage II pressure
ulcers. Ostomy Wound
Manage. 2003;49(9):44-51.
Evidence Level = II
Meaume S, Vallet D, Morere
M, Tot L. Evaluation of a
silver-releasing hydroalginate
dressing in chronic wounds
with signs of local infection. J
Wound Care. 2005;14(9):4119.
Aqua Cell
104
Type of Study
Sample
Intervention(s)
(median 17.0)
Control 17.4 +/- 3.7
Results
Limitations
Systematic
reviews of 7 RCTs
in burns and
infected surgical
wounds
Honey compared to
amniotic membrane,
potato peels (N =20) and
polyurethane film
Time to healing
Infection rate
105
Infected postoperative
wounds comparing honey
to antiseptics and
syste4mic antibiotics
showed much shorter
times for healing,
eradication of infection
and shorter hospital stay
for honey. Portion of
wounds healed without
dehiscence or resuturing
was 22/26 (85%)
compared to 12/24 with
antiseptic.
Moderate to severe burns
showed honey to be less
effective than tangential
excision and grafting. Half
of the patients treated
with honey eventually
needed eventual skin
grafting.
Patients with partial or
superficial burns treated
with honey were
significantly shorter times
to healing than film
dressings, amniotic
Type of Study
Sample
Intervention(s)
Results
Limitations
RCT
Prospective,
Descriptive
Takahashi J, Yokota O,
Fujisawa Y, Sasaki K, Ishizu H,
Aoki T, et al. An evaluation of
polyvinylidene film dressing
for treatment of pressure
ulcers in older people. J
Wound Care.
2006;15(10):449.
Prospective, open
label,
nonrandomized
control trial of
food wrap (a semi
occlusive dressing)
53 patients from 2
geriatric wards in Japan
of Stage III or IV PrU,
using only the most
severe ulcer for inclusion.
Only yellow PrU studied
because they are highly
exudating
Evidence Level = II
26 control
27 experimental
1 treated in the
experimental group got
well and dropped out; 18
subjects dropped out (7
in the experimental and 9
106
Comparison of groups at
baseline not provided
From Reviewers:
When the adverse
events were reported in
this study, the
denominator was the
enrolled number, not
the number who
completed the study.
The experimental
Type of Study
Sample
Intervention(s)
Results
Limitations
dressing relied on
autolytic debridement
which
immunocompromised
patients may not have
RCT
107
Results in wound
Type of Study
LaMaster K, Tennyson T.
Acemannan hydrogel dressing
versus saline dressing for
pressure ulcers. A
randomized, controlled trial.
Adv Wound Care.
1998;11(6):273-6.
Sample
Intervention(s)
HHC enrolled , 11
dropped
Retrospective
chart review of
1891 patients with
4200 wounds.
3969 wounds
Limitations
11 subjects dropped; 4
experimental and 2
control died, 1 subject in
each group showed
worsening of the study
ulcer and was
terminated, 1 subject in
each group was
hospitalized and
dropped, 1 subject in
control group was
dropped for protocol
violation
Therefore 30 subjects
were analyzed
Viamontes L, Temple D,
Wytall D, Walker A. An
evaluation of an adhesive
hydrocellular foam dressing
and a self-adherent soft
Results
108
Type of Study
were pressure
ulcers (95%), 18
(>1%) stage I;
1856 (47%) stage
II; 1539 (39%)
stage III; 194 (5%)
stage IV.
Purpose was to
compare
performance of
foam and silicone
dressings
Random
assignment
polymen
(polymeric
membrane
dressing vs.
antibiotic
ointment and dry
dressing
RCT over 5 weeks
Sample
Intervention(s)
Results
Limitations
4 weeks
Outcomes rate of healing
PUSH measurements
Acetate tracings for area
Mobility levels assessed via Braden
subscale
109
Type of Study
Sample
Intervention(s)
repositioning program
Results
Limitations
score compared to in
control group of 6.55 +/2.12. p < .001
VAC compared to
wet-dry
Randomized trial
22 patient grade 3
(Europe) pelvic region
Reference
Type of Study
Sample
Intervention(s)
Baxter H. A comparison of
two hydrocolloid sheet
dressings. Br J Community
Nurs. 2000;5(11):572.
Clinical essay.
Complete healing in 5
ulcers in 5 weeks in
Treatment group, no PrU
in control group healed
completely
No difference
Indirect Evidence
110
Results
Limitations
Bergemann R, Lauterbach
KW, Vanscheidt W, Neander
Type of Study
Cost analysis
prospective
Sample
Intervention(s)
111
Results
Limitations
dressings comfortable
and acceptable with
pain reduction reported
in superficial pressure
sours and trauma
wounds.
Gauze is expensive
when time is factored
Type of Study
Sample
Intervention(s)
Experimental
112
Results
Limitations
into cost.
Acticoat is a low
adherent primary
wound dressing,
nanocrystals release at
70 mg/l. Has the most
rapid effect
AquaCel Ag is a
hydrofiber with ionic
silver, dressing is
absorbent
Contreet is a
polyurethane foam,
silver is released when
Type of Study
Sample
Intervention(s)
Results
Limitations
dressing contacts
exudate. Slower onset
of action than Acticoat
Actisorb Ag is activated
charcoal with metallic
silver, broad spectrum
including fungi and
bacteria. Odor is
reduced with activated
charcoal.
Urgotul SSD is a
hydrocolloid with silver
sulfadiazine
Avance is a
polyurethane foam with
a silver complex.
Silver stains the wound,
but is removable with
cleansing. No known
bacterial resistance.
Subset of human
patients with
experimentally
created wounds in
a larger study that
included
hydrocolloid and
saline dressings
This was
comparing balsam
of Peru, castor oil
and trypsin
ointment
(Xenaderm) and
balsam of Peru,
castor oil and
trypsin spray
(Granulex)
Literature review.
36 randomized
controlled studies focus
on saline, hydrocolloid,
and human skin
construct.
Decisions regarding
ulcer treatment
protocols should not be
relayed solely on the
initial cost of materials.
113
Type of Study
Sample
Case study
1 case study
Case studies
5 of mixed wounds, 2
were PrU on sacrum
Perspective
randomized 5
week controlled,
open label,
multicenter study
Compared gauze
dressing with
antimicrobial to
control gauze
without antimicrobial in PrU,
surgical wounds
and diabetic foot
wounds
2121 patients with
wounds; 20.7%
PrU
Intervention(s)
Results
Limitations
Hydrocolloid dressing is
the most cost effective
when considering the
labor intensive of
dressing changes 3-4
times per day.
WTD cost $2.50 for
dressings and $20 for
nursing = 675 (we
recomputed for 9 days =
$607.50
MWH $8.00 for product
plus $20 for nursing =
$84
114
From abstract
Type of Study
chronic wounds. Br J
Community Nurs. 2003;8(11
Suppl):18-22.
Observed for 12
weeks after
changing to Tielle
Uncontrolled ,
prospective openlabel study
Case studies
Case review of 10
patients (but chart
data only lists 7
patients)
Sample
Intervention(s)
Results
Limitations
Wound volume
Duration
Time in days to heal
Volume of healing over time
115
Type of Study
Sample
Intervention(s)
Results
Ave starting volume 196
mm3
Ave max volume 957
mm3
Duration prior was 7.0
months
Ave time to heal
wounds was 35 days
Wound volume decreased
by 564 mm3 (due to
increase in initial wound
size after treating)
116
Limitations
Type of Study
Sample
Randomized
clinical trial
26 patients: 15 patients
with 25 PrU treated with
honey vs. 11 patients
with 25 PrU treated with
ethoxy-diaminoacridine
plus nitrofurazone
Retrospective
Descriptive study
of 17 long-term
care patients with
stage III/IV ulcers
17 ulcers: 7 sacrum, 7
trochanter, 3 ischial
Intervention(s)
Results
Culturing PrU
from surgically cleansed
sites allows for isolation of
bacteria species &
antibiotic susceptibility
Good
Also in Table 9 - dressings
Heym B, Rimareix F, LortatJacob A, Nicolas-Chanoine
MH. Bacteriological
investigation of infected
pressure ulcers in spinal cordinjured patients and impact
on antibiotic therapy. Spinal
Cord. 2004;42(4):230-4.
Limitations
Study not blinded,
limited to stage II-III,
variability in potency of
antimicrobial effects
with unprocessed
honey, not clear if
cleanser ethoxydiaminoacridine alone
could have affected
results
Aggressive cleansing &
debridement of ulcer
during OR might have
effected results
Fair
117
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Results
Limitations
Prospective,
nonrandomized
18 PrU wounds
2004 Delphi
Survey to id
clinical signs of
wound infection in
6 wound types
Prospective,
nonrandom
Development and
reliability testing
of clinical signs
and symptoms
Standardize assessment-2
independent assessments for 31
patients using CSSC, percent
agreement & Kappa
Good
Cutting KF, White RJ,
Mahoney P, Harding KG.
Clinical identification of
wound infection: a Delphi
approach in European Wound
Management. Identifying
criteria for wound infection
EWMA Position Document.
London2005. p. 6-9.
Strong- beginning to correlate
clinical features with micro
lab results
Davies CE, Hill KE, Newcombe
RG, Stephens P, Wilson MJ,
Harding KG, et al. A
prospective study of the
microbiology of chronic
venous leg ulcers to
reevaluate the clinical
predictive value of tissue
biopsies and swabs. Wound
Repair Regen. 2007;15(1):1722.
Strong
Gardner SE, Frantz RA, Troia
C, Eastman S, MacDonald M,
Buresh K, et al. A tool to
assess clinical signs and
118
Type of Study
symptoms of localized
infection in chronic wounds:
development and reliability.
Ostomy Wound Manage.
2001;47(1):40-7.
Strong
Gardner SE, Frantz RA,
Saltzman CL, Dodgson KJ.
Staphylococcus aureus is
associated with high
microbial load in chronic
wounds. Wounds.
2004;16(8):251-7.
Sample
Intervention(s)
Observational
cross-sectional
Observational
cross-sectional
Observational
cross-sectional
Observational,
cross-sectional
Strong
Gardner SE, Frantz RA,
Saltzman CL, Hillis SL, Park H,
Scherubel M. Diagnostic
validity of three swab
Limitations
Strong
Results
119
Type of Study
Sample
Intervention(s)
Results
Limitations
Cross-sectional
design
Nonexperimental,
descriptive
10 chronic wounds
Prospective,
nonrandomized
44 PrU wounds
Results
Limitations
Many assumptions
made, article
availability. Bias with
Type of Study
Sample
Intervention(s)
Search of 6
databases
41 articles
120
Type of Study
Sample
Intervention(s)
Results
Limitations
Good
Bergin SM, Wraight P. Silver
based wound dressings and
topical agents for treating
diabetic foot ulcers. Cochrane
Database Syst Rev. 2007(2).
Randomized trials
& nonrandomized
Randomized and
pseudorandomized
(alternate
allocation)
This is a protocol
Questionnaire
including
observational
about infection
status of wound
Varying levels of RN
wound education
No burns/leg ulcers
looked at wounds
healing by 2ndary
intention, RNS of
varying experience,
unknown if PrU
included
Retrospective data
base from general
practice databases
N/A
Searched 16 databases
23 studies
Strong
Bradley M, Nelson EA,
Pettigrew M, Cullum N,
Sheldon T. Dressings for
pressure sores. Cochrane
Database Syst Rev.
1998;3:CD001179.
Strong
Cutting KF. Identification of
infection in granulating
wounds by registered nurses.
J Clin Nurs. 1998;7(6):539-46.
Fair
Training is key to
identification of subtle signs
of infection
Howell-Jones RS, Price PE,
Howard AJ, Thomas DW.
Antibiotic prescribing for
chronic skin wounds in
primary care. Wound Repair
Regen. 2006;14(4):387-93.
Good- need to look at
antibiotic prescribing
practices role, duration, role
in resistance
Nelson EA, O'Meara S, Golder
121
Type of Study
Sample
Intervention(s)
Results
Limitations
dissimilar
Strong
Jull AB, Rodgers A, Walker N.
Honey as a topical treatment
for wounds. Cochrane
Database Syst Rev.
2004;2:CD005083.
Strong
O'Meara S, Cullum N, Majid
M, Sheldon T. Systematic
reviews of wound care
management: (3)
antimicrobial agents for
chronic wounds; (4) diabetic
foot ulceration. Health
Technol Assess. 2000;4(21):1237.
Strong
OMeara S, Cullum N, Majid
M, Sheldon T. Executive
Summary: Systematic reviews
of wound care management:
(3) antimicrobial agents for
chronic wounds; (4) diabetic
foot ulceration. Health
Technol Assess. 2000;4(21).
Strong
Randomized and
pseudorandomized
(alternate
allocation)
This is a protocol
30 studies, 25
with random, 9
evaluations of
systemic agents
and 21 topical
agents
18 databases Relevant
journals, confer, & bibs
were hand searched
Methodological
problems with most
common being sample
size
Random &
nonrandom trials
with concurrent
control group
which evaluate
intervention for
prevention or
treatment of
diabetic ulcers or
topical
antimicrobial for
chronic wounds
(including PrU)
RCTs and CCTs
19 databases including
Medline, CINAHL,
Embase & Cochrane.
Relevant journals, confer,
& bibs were hand
searched
Diabetic-39 trials
Antimicrobials- 30 with 25 of
randomized design. 9 evaluations of
systemic antibiotics, 21 of topical
agents
Antimicrobials-PrU: no evidence in
favor of topical antimicrobials for
PrU prevention, oxyquinolone
ointment significantly more
effective than standard emollient
for treatment of PrU in 1 study, no
significant difference between
hydrocolloid and povidone iodine
ointment or between gentian
violet and povidone iodine/sugar
ointment
Methodological quality
poor
3 studies
122
Type of Study
Sample
Intervention(s)
Results
Limitations
In-vitro
experimental
7 dressings:
Aquacel Ag,
Acticoat, Silvercel,
Contreet foam, polymem
silver, urogotul, silvasorb
Technique used
measured total
amount of silver in
solution and cannot
differ. between active
and inactive forms
Randomized and
pseudorandomized
(alternate
allocation),
published and
unpublished
This is a protocol
Systematic review
4 weeks of follow-up
Insufficient evidence to
recommend use of silvercontaining dressings or
topical agents for
treatment of infected or
contaminated chronic
wounds,
Greater reduction in ulcer
size was observed with
silver-containing foam but
no significant difference in
rates of complete healing
after 4 weeks
2006;23(4):341-7.
Strong
Parsons D, Bowler PG, Myles
V, Jones S. Silver
antimicrobial dressings in
wound management: a
comparison of antibacterial,
physical, and chemical
characteristics. Wounds.
2005;17(8):222-32.
Good
Ubbink DT, Vermeulen H,
Storm-Versloot MN. Topical
silver for preventing infected
wounds. (Protocol). Cochrane
Database Syst Rev. 2007;ID:
CD006478(2) DOI:
10.1002/14651858.CD006478
).
Strong
Vermeulen H, van Hattem JM,
Storm-Versloot MN, Ubbink
DT. Topical silver for treating
infected wounds. Cochrane
Database Syst Rev.
2007(1):CD005486.
Strong
123
Type of Study
Sample
Intervention(s)
RCT
RCT
N= 185 controls N ?
SCI with PrU
Pressure ulcers
N=8
Results
Limitations
Interrupted DC
Asymetric Biphasic
Wound healing
No significant difference
between topical HBO
alone and topical HBO
with electrical stimulation
Larger, controlled
study to determine
efficacy needed
Recommendation
based on data from all
chronic wound types
Prospective,
uncontrolled
Systematic Review
Induced ES ( PRFS)
Meta-analysis
15 studies
Systematic Review
Meta-analysis
124
Type of Study
Sample
Intervention(s)
healing: a meta-analysis.
Wound Repair Regen.
1999;7(6):495-503.
Stefanovska A, Vodovnik L,
Benko H, Turk R. Treatment
of chronic wounds by means
of electric and
electromagnetic fields. Part 2.
Value of FES parameters for
pressure sore treatment.
Med Biol Eng Comput.
1993;31(3):213-20.
RCT
N=185
Results
Limitations
Electrical stimulation
produces a substantial
improvement in the
healing of chronic wounds,
further research is needed
to identify which electrical
stimulation devices are
most effective and which
wounds respond best to
this treatment
Healing rate improved by
60% compared to controls
Type of Study
Sample
Intervention(s)
Pressure ulcers
RCT
N = 164
Small RCT
a control group
(n = 9), a US/UVC group
(n = 5), and a laser group
(n=6).
20 patients
Spinal cord unit/hospital
125
Results
Limitations
No significant effects
overall; sub-analysis
tendency toward
enhanced healing;
significantly larger
reduction in pressure
ulcers among patients with
low BMI
May be beneficial to
healing in individuals
with low BMI
Difficult to draw
conclusion as 2
treatment types
combined and
compared against
laser
Ultrasound-ultraviolet-C
may decrease healing time
Schubert V. Effects of
phototherapy on pressure
ulcer healing in elderly
patients after a falling
trauma. A prospective,
randomized, controlled study.
Photodermatol
Photoimmunol Photomed.
2001;17(1):32-8.
Thai TP, Keast DH, Campbell
KE, Woodbury MG, Houghton
PE. Effect of ultraviolet light C
on bacterial colonization in
chronic wounds. Ostomy
Wound Manage.
2005;51(10):32-45.
Type of Study
Pressure ulcers
Sample
Intervention(s)
N = 74
Results
Limitations
enhance healing in a
number of studies (10)
in chronic wounds and
UVC has been shown
to enhance healing
and decrease bacterial
levels in a small
number of studies
with a small number
of participants
Homogenous group by
age
A statistically significant
reduction of predominant
bacteria was noted
following a single UVC
treatment (P <0.0001, n =
22) (see Figure 3).
Furthermore, significant
reductions of MRSA (P
<0.05), S. aureus (P <0.01),
and other types of bacteria
(combination of P.
Pseudomonas aeruginosa
and Streptococcus group B
and G, (P <0.05) were
noted.
Prospective RCT
Pre-test, post-test
UVC treatment
study
22 individuals with
chronic wounds including
pressure ulcers (n = 7)
126
Type of Study
Sample
Intervention(s)
RCT
N =33; 23 completed 4
weeks; 16 completed 8
weeks of study
Warming Therapy
Prospective Noncomparative
clinical outcomes
trial
Results
Limitations
No conclusion can be
Reached specific to PrU
healing. MIST appears
to improve healing of
chronic wounds. Trend
is that this can be
applied to PrU as well
as other chronic
wounds with expected
good outcomes.
Validated measurements
and statistical methods
were used
Treatment=27
Control=28
Diabetic Foot
Ulcers
127
SWC
Type of Study
Sample
Intervention(s)
RCT
6 studies
Prospective ,
parallel group RCT
Non-healing leg
and foot ulcers
associated with
chronic critical
limb ischemia
Small RCT
a control group
(n = 9), a US/UVC group
(n = 5), and a laser group
(n=6).
6 studies of US
effect of healing
on chronic leg
ulcers
20 patients
Results
Limitations
Significant effect of US
on venous ulcers
demonstrated. Best
response noted from
low FQ 30kHz
Addition of MIST
statistically improved
healing of chronic
ischemic leg ulcers.
Study well designed ;
application to PrU
healing is probable not
proven
Also not proven: effect
on wound pain or
bacterial burden
Difficult to draw
conclusion as 2
treatment types
combined and
compared against laser
Ultrasound-ultraviolet-C
may decrease healing time
and may allow faster
return to rehabilitation
program, work, and leisure
activities for patients with
spinal cord injury who
have pressure ulcers.
RCT
Pressure ulcers:
16 Stage IV
72 lesser stage II
& III;
Stage II ulcers had
Treatment=45
Control=43
Sham US;
Cleansing: NS or chlorhexidine 0.1%
3.28 MHz ; SATA intensity 0.1 W/cm2 ;
treatment to wound edge and wound
bed (cover with Tegaderm and fill
volume with NS to transmit US)
Cleansing: NS or chlorhexidine 0.1%
128
Measurements: closure
rates: 0.18 mc2 / week for
US group; 0.31 cm2 /week
sham.
Points based on subjective
evaluation: US .71
points/week; sham .46
points/week
Type of Study
Sample
Intervention(s)
Results
Pressure ulcers
N = 40; 29 completed
study
Limitations
deaths from nontreatment related
causes.
Conclusion: cannot
demonstrate significant
beneficial effects for
infected or clean PrU
but treatment group
showed some better
clinical outcomes
Comment: due to
mixed stages, critically
ill elderly patients and
use of ATB and
Chlorhexidine for some
patients, this study has
significant flaws.
Small sample size
PSST
Results
Limitations
Prospective, RCT
Type of Study
Sample
Intervention(s)
Prospective
randomized trial
6 weeks duration
129
Age of sample:
NPWT mean age 41.7
years Cadexomer mean
age 54.4 years
Ulcer distribution:
Ischial = 9
Type of Study
Sample
Intervention(s)
Inclusion criteria:
Albumin2.0, age 21-80,
ulcer volume 10-150 ml
measured by plastic
wound impression
Exclusion criteria
Fistula, cancer,
pregnancy. lactation,
Graves disease, iodine
allergy, burns, sepsis,
uncontrolled DM,
orthopedic hardware,
renal or pulmonary
disease, use of steroids
Results
Limitations
Sacral = 17
Lateral malleolar = 4
Trochanteric = 1
Heel =4
130
Type of Study
Sample
Intervention(s)
Results
Limitations
No difference in capillary
numbers in either group
Prospective
randomized trial
comparing NPWT
to wet to moist
gauze dressings
covered with a
thin film to
simulate closed
therapy without
suction
Likely to be cooperative
All patients were offered
surgical closure of any
remaining wounds
131
3 wounds in NPWT
showed improved
osteomyelitis
CXId wounds (N not
stated) showed no
improvement in
osteomyelitis by biopsy or
MRI (p =0.25)
18 wounds were
randomized to treatment
group, each wound was
randomized. 3 patients
had wounds with both
therapies
Inflammation was
increased in WMG even
though no infection
present at start of
therapy
Group comparison
Age (p = ns)
NPWT mean 56
WMG mean 49
Gender (% Male) (p = ns)
NPWT 66%
WMG 44%
Wound depth (% change
in depth)
NPWT = 66%
WMG = 20%
(p 0.00001)
Wound length (% change
in length)
NS change (no detail
provided)
Wound width (% change in
width)
Actual numbers not
given
(p 0.02)
Type of Study
Sample
Intervention(s)
Results
Limitations
Retrospective
record review (N
=1262) of KCI
records for
qualification for
therapy in
patients who had
failed prior
interventions.
Data were
complete on 1032
records which was
more than 17,000
data entries
Prospective RCT
Wound age
Wound location
Prior dressings
Wound description
(color, dressing type odor and
amount)
Support surface
Reason for stopping NPWT
Wound healing rate computed
(cm2/day)
Wound volume (cm3/day)
Wound volume change (cm3/days)
132
Group comparison
Age p = NS
NPWT = 49 (25-73)
Dressing = 53 (34-77)
Gender
p = NS
Type of Study
Sample
Intervention(s)
wet)
Results
NPWT = 7 males
Dressings = 8 males
Initial mean wound
volume p = NS
NPWT = 50 (3-132)
Dressing = 42 (5-68)
Limitations
mechanical effect of
NPWT pulling on wound
edges
What was the effect of
the Ringers over Normal
saline used in most
wound care?
Oxygen Therapies
Reference
Type of Study
Sample
Pressure ulcers
N=8
Intervention(s)
Prospective,
uncontrolled
133
Results
Limitations
No significant difference
between topical HBO
alone and topical HBO
with electrical stimulation
Type of Study
Sample
Intervention(s)
Hirshberg J, Coleman J,
Marchant B, Rees RS.
TGF-beta3 in the
treatment of pressure
ulcers: a preliminary
report. Adv Skin
Wound Care.
2001;14(2):91-5.
Randomized, blind,
parallel, placebocontrolled trial (pilot
study)
N = 14 patients (6
women and 8 men)
subset of the 270 study
participants
N = 36 patients with
PrU of the foot
Prospective,
randomized, doubleblind trial
N = 44 completed the
study
Evidence level = II
Evidence level = II
134
Results
Limitations
Type of Study
Sample
Intervention(s)
Multicenter,
randomized doubleblinded trial
N = 20
Prospective,
multicenter, doubleblind, parallel group,
placebo-controlled
trial
Indirect evidence
Results
Limitations
135
Type of Study
Sample
Randomized, phase
I/II, double-blind,
placebo-controlled
study
N = 20 each
participant had a stage
III or IV ulcer of area 25
95 cm
Randomized, phase
I/II, double-blind,
placebo-controlled
study
N = 20 - each
participant had a stage
III or IV ulcer of area 25
95 cm
Intervention(s)
Limitations
Volume measurements of
pressure ulcers with alginate
molds were done on days 0, 7,
14, 21 and 29; other
measurements including
maximum depth crater, area of
ulcer opening and histology of
biopsy samples
Evidence level = II
Results
136
None listed
Type of Study
Sample
Plast Surg.
1992;29(3):193-201.
Evidence level = II
Evidence level = II
Intervention(s)
Prospective,
randomized, blind,
placebo-controlled
trial
N = 26 patients entered
the study and 24
patients completed the
study with pressure
sores extending from
the bone to the
subcutaneous tissue
(stage III IV)
137
Results
greater than that observed in the other
treatment groups; the depth of the ulcer on
day 29 was 14.1 7.4% of the day 0 depth in
the 100 g/ml treated patients compared
with 34.9 6.7% in the placebo-treated
patients; the 100 g/ml group had an overall
two-fold decrease in ulcer depth
throughout the treatment period compared
with all other groups; treatment differences
were found between the 100 g/ml dose
group and placebo and 10 g/ml groups (p
0.05); the volume of the ulcer on day 29 for
the 100 g/ml treated patients was 6.4
4.0% of the day 0 volume compared with
21.8 5.6% in the placebo-treated patients;
overall differences in the percentage of
initial volume between groups were not
statistically significant (p = 0.16); however
the data from the 100 g/ml demonstrated
1.6 to 2.2 fold decreases in overall volume
throughout the treatment period; 2 patients
in the 100 g/ml group received complete
healing
No dose adjustments were required and no
patient required discontinuance of the drug
because of toxicity; no statistical difference
was found between initial sizes in the
placebo and the rhu IL-1- treated groups;
no statistical significant differences were
seen in the percentage decreases in wound
volumes over the 29- day treatment
evaluation period were compared among
the various dosage groups or vehicle
placebo;
Limitations
None listed
Type of Study
Sample
Intervention(s)
Results
Limitations
A masked,
randomized pressure
ulcer trial
N = 61 inpatients
completed the 35-day
acute phase of the trial
with pressure ulcers
involving any tissue
from a bony
prominence to the
subcutaneous tissue
(grade III/IV)
None listed
Evidence level = I
138
Type of Study
Sample
Intervention(s)
Results
therapy were compared with patients
receiving placebo vehicles, significantly
more patients treated with cytokine
achieved a more than 85% decrease in ulcer
volume (P = .03); the bFGF-alone group had
significantly more patients than the placebo
alone group with more than 85% closure (P
= .02) and more than 90% closure (P = .04;
the sequential cytokine therapy reached a
significance level of P = .10 compared with
placebo at more than 85% healing; the
patients treated with GM-CSF alone did not
respond significantly better than placebotreated patients at more than 85% closure
(P = 0.22)
139
Limitations
Type of Study
Sample
Intervention(s)
Case Reports
Case Reports
Ao M, Mae O, Namba
Y, Asagoe K.
Perforator-based flap
for coverage of
lumbosacral defects.
Plast Reconstr Surg.
1998;101(4):987-91.
Results
Limitations
Efficient redistribution
of available tissue by
the combined use of
transposition and
advancement
principles resulted in
the repair of relatively
large skin defects with
reduced tension along
the closure.
Authors showed a
variety of flap design is
possible, such as trilobed, quadric-lobed,
step-ladder fashion,
fusiform, or elliptical.
Advantages are rich
vasculature to
facilitate transfer by
means of large flap
based on one or
several perforators
compared with
conventional skin
flaps. Adaptability of
flap design to defect,
easy donor site skin
closure not requiring
140
Type of Study
Sample
Intervention(s)
Results
Aslan G, Tuncali D,
Bingul F, Ates L, Yavuz
N. The "duck"
modification of the
tensor fascia lata flap.
Ann Plast Surg.
2005;54(6):637-9.
27 patients with
trochanter pressure
sores treated for
total of 31 flaps. 15
Right sided, 16 left
sided, 4 bilateral.
Average age 51 years
(range 19 76). All
patients either
quadriplegic (8) or
paraplegic (19).
Average defect
requiring coverage
was 11 X 9 cm (range
9 X 7 to 14 X 11 cm).
Case Reports
Ay A, Aytekin O,
Aytekin A.
Interdigitating
fasciocutaneous
gluteal V-Y
advancement flaps for
reconstruction of
sacral defects. Ann
Plast Surg.
2003;50(6):636-8.
14 patients with
sacral pressure sores
and 1 patient with a
chronic pilonidal
sinus.
4 female and 11
males, mean 38.2
years (range 16-57).
Mean diameter of
sacral defect 13.6
cm. (range 10 cm
17 cm).
Mean follow-up was
6 months (range 6-16
months).
From 1995 to 1997,
30 patients (18
female and 12 male)
were included. 17
were ambulatory, 13
paraplegic and
bedridden. 36 flaps
Case Reports
Case Reports
Three patients lost to follow-up. Of followup patients all flaps healed. One required a
second reconstruction due to necrosis, one
with wound infection closed the site by
secondary healing.
141
Limitations
skin grafting, and nonsacrifice of underlying
muscle.
The flap is reliable and
easily designed.
Formation of dead
space and the coneshaped dog-ear
deformity due to
rotation is prevented.
Better esthetic results
are achieved.
Suture separation is
prevented via a
tension-free closure.
The de-epithelialized
part produces tight
attachment of the flap
to the recipient bed.
No muscle tissue is
included so the flap is
more resistant to
pressure.
Digitizing the middle VY vascio-cutaneous
flap avoids a straight
line closure and the
resulting functional
defect.
Type of Study
the reconstruction of
pressure sores. Plast
Reconstr Surg.
1999;103(7):2071.
were surgically
placed. Some
patients had more
than one ulcer.
20 sacral, 8
trochanter, and 8
ischial ulcers were
included.
18 month
postoperative followup period with
regular checkups.
Between 1998 and
2001, 15 patients (11
male, 4 female) with
decubitus ulcers
surgically repaired
using gluteal fasciocutaneous rotationadvancement flaps
with V-Y closure.
Mean age 48.2 years
(range 34-84).
All ulcers stage IV.
Between 4 to 18 cm.
(mean 9.3).
10 patients with
assorted tissue
defects of the ankle
of foot region,
treated with 11
reverse sural artery
flaps.
Etiology factors were
pressure sores (4)
postsurgical
debridement (3)
trauma (3).
All procedures
performed by same
surgeon.
Borman H, Maral T.
The gluteal
fasciocutaneous
rotation-advancement
flap with V-Y closure in
the management of
sacral pressure sores.
Plast Reconstr Surg.
2002;109(7):2325-9.
Sample
Intervention(s)
Results
Limitations
Case Reports
The technique is
simple, can be
performed quickly, has
minimal associated
morbidity, and yields a
good outcome.
Case Reports
Healed ulcers.
142
Type of Study
Sample
Intervention(s)
63 consecutive
patients undergoing
bilateral gluteus
maximus V-Y
advancement
musculo-cutaneous
flaps with
refinements.
Case Reports
32 patients, 16 men
and 16 women,
operated on
between Nov. 1998
and June 2002 on
pressure sores at
various sites. Mean
age of 53.1 years
(range 5 to 87 years).
All grade III or IV per
Shea classification.
22 sacral, 7 ischial, 6
trochanter. 18
patients plegic, and 5
bedridden.
114 consecutive
patients undergoing
flap coverage of 139
ischial pressure sores
between 1979 and
1995
Case Reports
Case Reports
22 consecutive
elderly patients with
27 pressure sores
operated on
between 1995 and
1998 by the same
surgeon.
Case Reports
Results
Limitations
No significant
functional impairment
related to the flap
procedure was noted.
No inclusion or
exclusion criteria
presented.
Freedom in flap design
and low donor-site
morbidity make the
gluteal perforator flaps
and excellent choice
for pressure sore
coverage.
Detailed information
collected from 112 flaps in 87
unselected patients from the
initial 114 patients. 64 men
and 23 women, mean age
49years (range 16 90).
89% were paraplegic, 4%
quadriplegic, and 7%
ambulatory.
Follow-up ranged from one
month to 9 years, average
10.7 months.
Patients categorized into
three groups based on ulcer
location: sacrum, trochanter,
or ischium.
19 sacral ulcers, 7 trochanter
ulcers, and 1 ischial ulcer.
Four patients had both sacral
and trochanter ulcers and
Patient selection is
critical to the outcome
of surgical treatment
for pressure sores.
Comprehensive
postoperative
rehabilitation is
essential.
143
Type of Study
Surg. 2002;48(6):63340.
Sacral group of 11
men and 8 women,
mean age 61. 14
were nonambulatory, 2 very
poor ambulatory,
and 3 ambulatory.
16 stage IV ulcers
and 3 stage III.
Of the 22 patients, 4
were lost to followup. Average followup of the remaining
18 was 6 months
(range 3 months to 2
years).
Sample
Homma K, Murakami
G, Fujioka H, Fujita T,
Imai A, Ezoe K.
Treatment of ischial
pressure ulcers with a
posteromedial thigh
fasciocutaneous flap.
Plast Reconstr Surg.
2001;108(7):1990.
Case Reports
11 pressure ulcers in 10
paraplegic patients
surgically repaired
Ichioka S, Okabe K,
Tsuji S, Ohura N,
Nakatsuka T. Distal
perforator-based
fasciocutaneous V-Y
flap for treatment of
sacral pressure ulcers.
Plast Reconstr Surg.
2004;114(4):906-9.-5.
Since 1993,
management of 32
patients (21 men and
10 women). Mean
age 62.3 years (range
20-88 years). All
stage IV ulcers, mean
defect size of 10.8
cm, (range 8-16 cm).
All reconstructed
with a unilateral flap.
Average follow-up
period was 54.8
months (range 3-124
months).
Case Reports
Intervention(s)
Results
Limitations
and four women, mean age 66 years, all noambulatory with grade IV ulcers.
No complications, 100% excellent outcomes
at 6 months follow-up.
Ischial patient, a 50 year old paraplegic, had
a grade IV sacral and a grade IV ischial ulcer.
Postoperative dehiscence with revision.
Final outcome excellent healing.
144
It is imperative
postoperative care be
utilized to prevent
recurrence.
Type of Study
Sample
Intervention(s)
Ichioka S, Okabe K,
Tsuji S, Ohura N,
Nakatsuka T. Triple
coverage of ischial
ulcers with
adipofascial turnover
and fasciocutaneous
flaps. Plast Reconstr
Surg. 2004;114(4):9015.
17 male and 5
female patients were
treated. Mean age
46.3 years (range 2784 years). 17
patients were
paraplegic, one was
quadriplegic, four
with cerebral
infarction, spina
bifida, and multiple
sclerosis.
All patients had stage
IV ulcers.
Case Reports
24 fresh cadavers
were dissected.
21 patients
underwent a clinical
study between
January 1999 and
November 2003
where 22 tensor
fasciae latae
perforator flaps were
performed, one
bilaterally.
Mean age 40 (range
19-70 years).
19 patients
paraplegic and 2
paraparetic.
Mean ulcer size was
6.65 X 6.54 cm.
Mean flap size was
7.5 X 13.22 cm.
Ulcer size ranged
from 4 X 5 cm to 5 X
Case Reports
Results
Limitations
145
Jsvay J, Sashegyi M,
Kelemen P, Donth A.
Clinical experience
with the hatchetshaped gluteus
maximus musculocutaneous flap. Ann
Plast Surg.
2005;55(2):179-82.
Type of Study
Sample
Intervention(s)
Results
Limitations
10 cm.
Of the 22 flaps, 17
had 1 or 2
perforators, three
had 3 perforators
and the largest flap
had 21 perforators
intact for a mean of
1.81.
Between January
1998 and December
2003 this method
was used on 54
patients and 71 total
flaps.
Age ranged from 10
weeks to 72 years.
Follow-up period was
10 to 64 months.
Case Reports
Jsvay J, Donth A.
Modified hamstring
musculocutaneous flap
for the coverage of
ischial pressure sores.
Plast Reconstr Surg.
1999;103(6):1715-8.
Report of a V-Y
advancement of the
hamstring muscles
and overlying skin on
one 18 year old
patient born with
spina bifida and
paraplegic since
birth.
Case Report
Case Reports
146
Distally based
superficial sural flap
has advantages of
being easy to perform,
short operating time,
minimal donor site
morbidity, and
Type of Study
for coverage of
defects at the lower
leg and foot.
Mean follow-up was
2 years
15 patients had
trauma to the lower
leg, 3 had post burn
contracture, 2 had
pressure sores.
Flap size from 3 X 4
to 8 X 10 cm.
Ohjimi H, Ogata K,
Setsu Y, Haraga I.
Modification of the
gluteus maximus V-Y
advancement flap for
sacral ulcers: the
gluteal
fasciocutaneous flap
method. Plast
Reconstr Surg.
1996;98(7):1247-52.
24 patients with
sacral ulcers treated
with this variation of
the V-Y flap.
19 had sacral
pressure ulcers, 2
had radiation ulcer.
18 of the group were
ambulatory.
Age range from 20 to
91 years.
Mean defect size was
9 cm (range 5 to 15
cm in transverse
diameter)
Follow-up mean was
24.3 months (range 2
to 60 months).
Average blood loss
was 250 ml during
surgery.
37 paraplegic
patients with 31
ischial pressure sores
of moderate size.
31 consecutive
Sample
Case Reports
Intervention(s)
injuries.
Fasciocutaneous flap was
used in 14 cases and a fascial
flap covered with skin graft in
6 cases.
Treatment of acute trauma
included radical wound
debridement followed by a
distally based superficial sural
flap. In 8 cases the flap was
performed immediately after
debridement, in 12 others
defects were covered within
the first week of injury.
Three had simultaneous
tendon reconstruction and 7
patients with underlying
fractures required bone
fixation.
Defects with average size of
6.7 X 7.6 cm were
reconstructed with unilateral
gluteal fasciocutaneous flaps
Defects of average size of
11.2 X 11.1 cm were
reconstructed with a bilateral
gluteal fasciocutaneous flaps.
Description of experience
Results
Limitations
preservation of major
arteries of the leg.
The gluteal
fasciocutaneous flap
method for sacral
defects decreases
blood loss and
shortens the operating
time during surgery
compare with the
conventional gluteus
maximus musculocutaneous flap
methods.
147
Type of Study
Sample
maximus
musculocutaneous
island flap: an analysis
of 31 flaps. Br J Plast
Surg. 1994;47(6):4314.
ischial wounds.
20 males and 7
females
Age mean of 35 years
(range 15 to 47
years).
All patients suffered
from post-traumatic
paraplegia, 4 of
which had
undergone earlier
attempts at wound
closure.
28 patients with
stage IV sacral or
coccygeal pressure
ulcers.
Mean defect size 4 X
4 cm.
Mean follow-up of 15
months (range 2 to
40 months).
20 males and 8
females age range 14
to 78 years (mean
age 36 years).
Average time from
onset of ulcer and
surgery was 6
months.
21 sacral ulcers, 7
coccygeal ulcers.
Average size of ulcer
at surgery was 4 X 4
cm (range 2 x 2 to 10
X 10cm).
All patients followed
in hospital for
minimum of 8 weeks.
Intervention(s)
148
Results
Limitations
Advantages of the
gluteal maximus
muscle-splitting
myocutaneous flap
include reduced blood
loss, preservation of
most of the gluteus
maximus for future
use, and retained
function of the gluteus
maximus for stair
climbing and singlelimb support in the
ambulatory patient.
Type of Study
Sample
Intervention(s)
Scheufler O, Farhadi J,
Kovach SJ, Kukies S,
Pierer G, Levin LS, et
al. Anatomical basis
and clinical application
of the infragluteal
perforator flap. Plast
Reconstr Surg.
2006;118(6):1389-400.
13 patients, 11 men
and 2 women, mean
age 47 (range 33 to
68 years).
9 ischial ulcers, 3
sacral, 1
trochanteric.
Mean ulcer size at
time of surgery 44.6
cm X 14.2 cm (range
25 to 64 cm).
All ulcers grade IV of
V.
Divided into two
groups, Group A
perforator-based flap
reconstruction and
Group B perforator
flap reconstruction.
Case Reports
Case Reports
Results
Limitations
The
musculocutaneous
vastus lateralis flap is
important in the
treatment of
complicated recurrent
pressure sores and
defects after vascular
occlusion at iliac level.
The disadvantages of
some blood loss and
slightly difficult
dissection are
outweighed by the
advantages of a big arc
149
Tavakoli K, Rutkowski
S, Cope C, Hassall M,
Barnett R, Richards M,
et al. Recurrence rates
of ischial sores in paraand tetraplegics
treated with hamstring
flaps: an 8-year study.
Br J Plast Surg.
1999;52(6):476-9.
Tunbilek G, Nasir S,
Ozkan O, Kayikiolu
A, Mavili E. Partially
de-epithelialized and
buried V-Y
advancement flap for
reconstruction of
sacrococcygeal and
ischial defects. Scand J
Plast Reconstr Surg
Type of Study
Follow-up or 27
patients who
underwent
musculocutaneous
flap closure of their
ischial pressure
sores.
37 ulcers treated
between 1988 and
1993 using a V-Y
advancement
hamstring
musculocutaneous
island flap.
Initial follow-up in
1993, mean period
20 months.
Second follow-up
1997 mean period 62
months (range 18 to
90 months)
Mean age second
follow-up of 43.7
(range 11-77 years).
13 males 10 females
23 patients followed
second round, 4 lost
from initial followup.
16 patients operated
on using this
technique.
Age range 23-67
years.
Defect size range 6
16 cm in diameter.
No previous
treatment of soft
tissue defects.
Sample
Intervention(s)
Results
Limitations
Follow-up or prior
surgeries.
Case Reports
150
Type of Study
Sample
Case Reports
Intervention(s)
151
Results
Limitations
provides an extra
cushion of soft tissue
putting the suture line
directly over the bony
prominences.
Type of Study
Sample
Case Reports
Yamamoto Y,
Tsutsumida A,
Murazumi M, Sugihara
T. Long-term outcome
of pressure sores
treated with flap
coverage. Plast
Reconstr Surg.
1997;100(5):1212-7.
53 paraplegic
patients with 45
ischial and 24 sacral
sores between 1990
and 1995 were
treated with flap
coverage.
48 males and 5
females ages ranging
from 17 75 years
(mean 50).
Two types of flaps
were used:
Type I
:Fasciocutaneous flap
and Type 2.)
myocutaneous flap.
Average follow-up
was 3 years and 6
months (range 4
months to 5 years
and 4 months),
Case Reports.
Intervention(s)
Results
Limitations
Advantages include:
preservation and
inclusion of the
dominant perforator
augments the blood
supply of the
fasciocutaneous flap
and allows the same
amount of
mobilization as the
classic design, The
improved vascularity
renders the flap more
robust and better able
to withstand pressureinduced ischemia, and
in the event of
recurrence, re-rotation
is possible.
Long term follow-up is
essential in order to
lean which flaps are
better suited for
differing types of
reconstructive
surgeries.
straight line.
152
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Akyrek M, Safak T,
Snmez E, Ozkan O,
Keik A. A new flap
design: neural-island
flap. Plast Reconstr
Surg.
2004;114(6):1467-77.
Case Reports
Case Reports
Case Reports
Results
Limitations
6 bilateral myocutaneous
flaps were used for
reconstruction post radical
vulvectomy. 5 were used for
reconstruction after
contracture scar removal.
Follow-up between 5 and 27
months
153
Type of Study
Sample
Results
Limitations
Case Reports
Case Reports
14 patients with 15
defects of the lower
leg, malleolar, and
heel regions. Seven
patients were
vascularly
compromised
seriously.
Age range was 4 -81
years. Defect sites
were heel (6), lower
leg (2), lateral
malleolus (4), and
one calcaneus and
one dorsum of foot..
Defect size range was
3 X 3 cm to 10 X 14
cm.
Between 2003 and
2004. 4 children (3
male, one female)
Intervention(s)
154
Type of Study
Sample
Knox K, Bitzos I,
Granick M, Datiashvili
R, Benevenia J,
Patterson F.
Immediate
reconstruction of
oncologic
hemipelvectomy
defects. Ann Plast
Surg. 2006;57(2):1849.
Llanos S, Caldern W,
Searle S, Quintas M.
Improvement of the
bipedicled fascial flap
with a cutaneous V
and Y island for
Results
Intervention(s)
Case Reports
A random fasciocutaneous
flap with bilateral
adipofascial pedicles using
the stepped incision
technique in combination
with the V-Y advancement
None reported
3 males and 8
females with a mean
age of 43.8 years.
Tumor types
consisted of
chondrosarcoma (6),
Paget osteosarcoma
(1), giant cell tumor
(1), malignant fibrous
histiocytoma (1),
squamous cell
carcinoma (1),
synovial sarcoma (1),
and metastatic
uterine carcinoma
(1).
Case series;
reproduction of
Hayashi, A, et al.,
Stepladder V-Y
advance-ment flap
for repair of postero-
4 cases
155
Limitations
in adults for soft tissue
reconstruction.
Many surgeons still
hesitate to perform PFFs
in children due to
perceived high failure
rates related to the small
diameter of childrens
perforator vessels.
This flap is a viable
alternative to PFFs for
use in children with soft
tissue defects requiring
surgery.
Reconstructive surgery
following large pelvic
resections used as a
management tool to deal
with complications of a
primary closure, and
It can be implemented
for immediate closure
when primary closure is
not possible, when there
is significant dead space,
when vital pelvic
structure or organs are
exposed,
Primary reconstructive
option remains the
pedicled muscle flap.
Type of Study
Sample
Oberlin C, Azoulay B,
Bhatia A. The
posterolateral
Limitations
Three criteria
1) Patients injured the weight
bearing area of the sole and
heal before age 10 and initial
reconstruction using tissue
other than the sole and heel
was performed.
2). Follow-up observation
was possible for more than
10 years
3). Follow-up observation
was possible until age 15 or
older.
Case Reports
Roentgenographic
examination was performed
in two planes. Special
attention was directed to
osseous abnormalities such
as osteophytes and
osteomyelitic sequestrate in
the region of the free flap.
Biomechanical examination
of the foot. Gait and its timestrength characteristics were
analyzed. Foot function was
examined, including the
weight bearing pattern on
rolling of the foot, the
vertical force component,
and the maximum pressure
distribution on standing and
walking.
Both studies were performed
before and after treatment.
Case Reports
36 patients with 37
free flaps included all
who did not develop
trophic ulcers on
their transferred
flaps.
21 patients (37%)
found to have
trophic ulcers.
From 1988 to 1993
14 flaps were
performed in 13
Results
Case Reports
principle.
Intervention(s)
156
Type of Study
patients. 10 mend
and 3 women.
Mean age 54 years
(range 35 to 75
years).
10 patients had heel
injuries the
remaining patients
had skin defects over
the Achilles tendon,
the lateral malleolus,
and the medial
malleolus.
Eight cases of bone
loss, including four
cases of significant
defects in the
calcaneus.
5 patients with
absent lower limb
pulses, one case of
diabetes, one
unspecified
neurologic disorder,
and one paraplegic
Flap mean size was
13.5 cm long by 3 cm
wide (range 9 cm X
2.5 cm to 17 cm X 3
cm)
Donor defect closed
with skin grafts in 11
patients, primarily
closed in 2 patients.
One patient died 3
weeks after bilateral
heel coverage that
had fully healed.
11 fasciocutaneous
flaps were used in 10
patients.
Follow-up of 1 to 3
years.
Sample
Intervention(s)
Results
Limitations
Case Reports
None reported
Flap survival with wound closure
157
Type of Study
24 patients
underwent posterior
thigh
fasciocutaneous flaps
between 1989 and
1992
Follow-up ranged
from 2 to 20 months.
Sample
fasciocutaneous flap,
and a proximally based
fasciocutaneous flap.
Case Reports
Safak T, Akyrek M.
The descending branch
of the superficial
circumflex artery
supplying
anteromedial thigh
skin. Plast Reconstr
Surg.
2004;114(5):1118-22.
10 patients with a
mean age of 45
(range 10 to 60
years) between Oct.
1999 and Jan. 2002
underwent defect
flap repairs.
6 male and 4 female.
6 free flaps and 4
local flaps were used
in the 10 patients.
Case Reports
Yildirim S, Taylan G,
Akz T. Freestyle
perforator-based V-Y
advancement flap for
reconstruction of soft
tissue defects at
various anatomic
26 perforator V-Y
advancement flaps in
24 patients
performed between
July 2004 and
November 2005.
14 female and 10
Case Reports
Intervention(s)
Results
Limitations
A posterior thigh
fascioucutaneous flap
based primarily on the
first and secondary
profunda femoris
perforating arteries
provides versatility and
reusability.
158
Type of Study
males.
Mean age 48.3 years
(range 22 to 77
years).
Defect size range: 3 X
5 cm to 15 X 20 cm.
15 flaps (57.6%) were
elevated based on
two perforators, 7
flaps (26.9%) were
elevated based on
one perforator, and
the remaining 4
(16.8%) were
elevated based on
three perforators.
Mean follow-up as
14.2 months (range 9
to 21 months).
Sample
Intervention(s)
the wound.
159
Results
Limitations
successfully.
Other flaps survived totally (92.4%),
previously described
vascular anatomic
pattern
Type of Study
Sample
Intervention(s)
Abbas SQ.
Diamorphine-Intrasite
dressings for painful
pressure ulcers. J Pain
Symptom Manage.
2004;28(6):532-4.
Retrospective study
17 patients (9 females,
8 males) with a
diagnosis of incurable
malignancy admitted
with Grade 2+ PrUs
over a period of 30
months. Mean age was
68 years (range 47-89).
Retrospective
exploratory study
(March 2002
December 2004).
InterRAI PC comprehensive
assessment form, Cognitive
Performance Scale, ADLHierarchy Scale, MDSDepression Rating Scale, Pain
Scale, Pressure Ulcer, &
prognosis.
Brown G. Long-term
outcomes of fullthickness pressure
ulcers: healing and
mortality. Ostomy
Wound Manage.
2003;49(10):42-50.
Chaplin J. Pressure
sore risk assessment in
palliative care. J Tissue
Viability.
2000;10(1):27-31.
Retrospective
correlational study
for 5 year period
(1998-2002).
Structured review of
computerized medical record
data.
Comparative analysis
of professional
judgment of
experienced
palliative care
nurses.
Methodological
study.
Pressure ulcers
Medical records for 74
inpatients (1 female)
who developed FT
pressure ulcers in a VA
Med Center (acute care,
intensive care, long
term care)
Comparative analysis of
professional judgment
of experienced
palliative care nurses
via who did 529 risk
assessments on 291
patients.
Pressure ulcers
160
Results
Limitations
Significant limitations,
same nurses used
professional judgment &
also rated with the risk
assessment tool. No
attempt to quantify tool
validity. No statistical
analysis of relationship
between judgment & tool
rating. No reliability
Type of Study
Eisenberger A, Zeleznik
J. Pressure ulcer
prevention and
treatment in hospices:
a qualitative analysis. J
Palliat Care.
2003;19(1):9-14.
Qualitative study,
using constant
comparative analysis.
Galvin J. An audit of
Quality improvement
Sample
Participants were 18
directors of clinical
services, 9 were MDs &
9 were RNs, & 10 direct
care nurses (mean 18
years total experience
& mean of 4 years in
hospice). None had
advanced practice
training in wound care.
No hospices would give
out family or patient
names so no interviews
done of these people.
Pressure ulcers
Sample=13 patients
from inpatient hospice
unit admitted over 7
months (mean age 77
years, 10 females).
Seven patients
completed study.
Inclusion criteria: Grade
II or III painful PrU, to
be inpatient for 1 or >
weeks. Exclusion
criteria: Grade I or IV
PrU, non-PrU. 12 on
sacral area, 1 heel, 62%
Stage II, mean size
9cm2.
Intervention(s)
Random assignment to 1 of 2
treatment sequences: 3 days
of IntraSite gel followed by 3
days of diamorphine gel, or
vice versa. IntraSite gel is
ready-mixed HDG & used as
placebo. Diamorphine gel
(0.1% weight to weight
mixture) was mixed with
IntraSite gel. Gels applied
1x/day & covered with
standard dressing. All
patients had pressure
relieving cushions &
mattresses & encourage to
change positions frequently.
Pre-trial, PrU location, size &
stage were documented.
Medical record audit.
161
Results
Limitations
testing of tool. For a
methodological study,
limited evidence/lit
review to support the
tool development. No
info on how many,
education level, age,
experience of any of
nurse raters involved in
the study.
Only US hospices
included. Lacked direct
report from patients &
family caregivers.
Type of Study
Sample
Intervention(s)
pressure ulcer
incidence in a
palliative care setting.
Int J Palliat Nurs.
2002;8(5):214-21.
P & I study.
Two-year continuous
audit of PrU
incidence on 16-bed
specialist palliative
care unit.
Retrospective check
of chart for why PrU
developed, stage
when first noted, and
action(s) taken.
admitted to palliative
care unit over 2 years
(2000-2001) with mean
age 68 (range 35-90).
Researcher-designed data
collection form placed on
chart within 6 hour of
admission for info on any
pressure damage, size,
appearance, treatment,
Waterlow Score, mattress &
seating surfaces, handling
aids. Info r/t PrU updated
weekly & on discharge.
Documented # of patients
with PrU, # developing in
unit, distribution & severity
of PrU, % of patients
discharged with PrU.
Descriptive study
with retrospective &
prospective
components in
outpatient hospice
agency.
Hanson D, Langemo
DK, Olson B, Hunter S,
Sauvage TR, Burd C, et
al. The prevalence and
incidence of pressure
ulcers in the hospice
setting: analysis of two
methodologies. Am J
Hosp Palliat Care.
1991;8(5):18-22.
Pressure ulcers
Pressure ulcers
Hatcliffe S, Dawe R.
Clinical audit:
Monitoring pressure
sores in a palliative
care setting. Int J
Palliat Care Nurs.
1996;2(4):182, 4-6.
Prospective point
prevalence survey
study.
Pressure ulcers
Retrospective study,
from 2003 through
2005
162
Results
Limitations
Retrospective format
limited to accuracy &
completeness of
Type of Study
McDonald A, Lesage P.
Palliative management
of pressure ulcers and
malignant wounds in
patients with
advanced illness. J
Palliat Med.
2006;9(2):285-95.
Review.
Comprehensive
search of MEDLINE,
CINAHL & Cochrane
Databases. Focus on
overview of general
principles of
palliative
management of PrUs
& malignant wounds.
Comparative open
prospective parallel
& block-randomized
study. Total 18mo
study period.
Intervention(s)
without malignant
disease who developed
a PrU. All were treated.
Patients with cancer
ranged from 3 month
94 years (mean=66.2),
patients without cancer
were 28-92 years
(mean=68), with NSD.
N=619
Inclusion: 18 or >, not
pregnant or lactating,
chronic wound with
delayed healing & modhigh exudates
8% were PrUs.
Results
Limitations
documentation.
Pressure ulcers
Exclusion: depth
<0.5cm
Sample
4 home hospice
programs Oct-Dec 2003.
Excluded LTC residents.
N=980
Pressure ulcers
163
Prevalence was
retrospective; incidence
reported and not directly
assessed by researchers
(although agency
pharmacist did reporting)
Reifsnyder J,
Hoplamazian LM,
Maxwell TL. Preventing
& treating pressure
ulcers in hospice
patients. Caring.
2004;23(11):30-7.
Type of Study
Sample
Retrospective (6
month review) &
prospective (3
month) study. Did
pre- and post-pilot as
well as baseline
studies of PrU
prevalence &
incidence in home
hospice patients I
Hospice Pharmacia,
October-December
2003. HP serves
approximately 20%
of all US hospice
patients.
Sopata M, Luczak J,
Ciupinska M. Effect of
bacteriological status
on pressure ulcer
healing in patients
with advanced cancer.
J Wound Care.
2002;11(3):107-10.
Prospective,
randomized trial.
34 patients with
advanced cancer (18 F,
16 M) & Stage II-III PrU,
24-88 (mean 59 year)
years old. Inclusion
criteria advanced
cancer & life
expectancy >8 year,
Exclusion criteria poor
general condition, Hgb
<7mmol/l & albumin
<2.5g/dl, use of
corticosteroids
Cross-sectional &
retrospective records
review. Two studies:
Prevalence study in
2003 (A),
retrospective chart
review in 2004 (B)
Pressure ulcers
Pressure ulcers
Study A: 383 patients in
large suburban hospice
during 2 week period in
2003 of which 2/3 were
nursing home residents.
Study B: Retrospective
med record review of
192 consecutive
patients referred to MD
Intervention(s)
Results
had higher risk on Braden scale & mean
Karnofsky scores significantly lower for
patients with PrU as compared to those
without.
PrU prevalence 14.6% in 6-month
retrospective study; 17.5% baseline; 26.9%
3-month study period. 3-month study PrU
incidence 10%. 50% Stage II. Mortality rate
81.2%; average LOS 84 days (range 1-1123
days) for those who died during study;
median LOS 31 days; average
Karnofsky/Palliative Performance Score 40.
Patients with cancer dx had fewer PrU than
patients without cancer dx (CNS disorders,
dementia). Group with higher PrU
occurrence were those with CVA or
dementia. Distribution of PrU stages similar
in Pre- and Post-pilot studies. Most PrU
Stage II (50%), Stage I=25%, Stage III=12%,
Stage IV=9%.
Randomly allocated to
Lyofoam/polyurethane foam
or Aquagel/HDG dressings &
dressings changed based on
clinical need. Noted efficacy,
treatment times & healing
rates. Study time 8 weeks or
until ulcer healed, and was 3
year study (Jan 1996 Jan
1999). All patients cared for
at Palliative Care Dept.
Dressings changed according
to clinical need. All patients
treated by 1 of 3 nurses.
164
Limitations
Retrospective studies
limited by accuracy &
thoroughness of data
documented. No
statistical analyses
reported for comparing
different time points or
diagnostic categories.
Limited demographic info
on subjects (no gender,
ethnicity/race, etc.). No
specifics given for how P
& I calculated for study.
Use of 4 agencies could
have limited consistency
in data collection &
interpretation.
Small sample size limited
generalizability. Five
patients died after 3rd
week assessment so were
included in analyses.
Retrospective audit
limited by completeness
& accuracy of
documentation. Limited
to patients in one large
metropolitan area, thus
may not be generalizable.
No training of nurse data
collectors, therefore type
Type of Study
Sample
Intervention(s)
Pressure ulcers
Walding M, Andrews
C. Preventing and
managing pressure
sores in palliative care.
Prof Nurse.
1995;11(1):33-4, 7-8.
20-bed inpatient
hospice unit. Preintervention
sample=115. All inpatients participated.
90% of patients have
malignancy.
Pressure ulcers
165
Results
Limitations
Indirect Evidence
Reference
Type of Study
Sample
Intervention(s)
Spiegelbergs
phenomenologic
al method qualitative
Semi-structured, face to
face, audio- taped interview
with wives. Field notes
taken. Each wife asked 8
questions. Demographic
info also obtained.
Qualitative pilot
study,
Heideggarian
phenomenology
with
interpretative
phenomenologic
al analysis.
Six Caucasian
wife/caregiver
to spouses with Stage
III-IV PrU & bedridden
or chair fast. Mean
age 76.5 year (range
69-82), all had
arthritis, 67% HTN,
50% severe back
problems, 50% taking
tranquilizers. Provided
care to husbands 2-10
year. Husbands mean
age 80.6 year (7388.5). All had fecal
incontinence, 50%
B&B incontinence, 2
had a Foley, 1 had
intermittent caths. No
Stage I or II PrUs, none
receiving >20hr/week
HHA. All were bed or
chair-fast &
dependent in ADLs.
Eight older adults from
4 centres, 3 in England
& 1 in Belgium.
Inclusion criteria
included older adults
with stage 3 or 4 PrU;
exclusion criteria were
spinal cord injury &
inability to provide
informed consent. Age
range 68-101.
Participants had other
co-morbidities.
Unstructured interviews
which acknowledged the
contribution of both the
participant & researcher.
166
Results
Limitations
Limited to Caucasian
wives, elderly (>60), NY
area. Need replication in
other ethnic groups &
rural areas. Not
followed longitudinally.
Type of Study
Randomized,
double-blind,
placebocontrolled design
Level
Quality: Strong
Case review
Sample
Intervention(s)
167
Results
restrictions were the worst part.
Impact on s/o & family. PrU also
caused extended hospital stay. Coping
with PrU & the consequences
facilitated thru comparing self with
others who had it worse. Acceptance
of situation with some fatalism, &
positive thinking seen as part of
getting on with their lives.
Sample size of 20/group for 90%
power with 95% confidence, assuming
0-10% rate of success in placebo group
& 50-60% success in metronidazole
group.
NSD between groups on age, weight, &
height; on frequency of treatment for
4 classes of wounds.
Was 100% success rate for
metronidazole group, mostly within 3
days & no adverse events; 76% success
rate in placebo group, & NSD between
groups. Patient & nurse odor ratings
sig correlated (p<.001), NSD in mood
state between groups over time.
Patient. A: (89 y/o) with 3x7cm painful
& inflamed subq upper tibial infiltrate.
Pain 4-8 pre- and 0-2 post. Patient B:
(56 y/o) cutaneous pain with sacral &
colostomy infiltration. Pain pre4-10
and post- 1 until last week of life it was
occasionally 6. Patient C: (71 y/o)
severe oral mucositis, pain pre- 10 &
post- 2-4. Patient D: ((71 y/o) painful
necrotic leg ulcers, pain pre- 10 & post4. Patient E: (69 y/o) with cancer of
larynx, pain pre- 9 & post- 2-4. Patient.
F: (62 y/o) vulvar cancer, pain pre- 6 &
post- 2. Opiod receptors are inactive in
non-inflamed tissue. After onset of
inflammation, opioid receptors
become activated within hours.
Morphine & diamorphine appear to do
Limitations
Assessments were
subjective, as no
objective tools
available. Ethical
challenges related to
odor & use of placebo
group.
Decrease in odor in
placebo group may have
been due to frequency
of dressing changes.
Observation periods
were short. Application
of gel to open wound is
difficult, especially with
much exudates, & much
of drug may be flushed
away. Need to identify
how morphine
absorbed through
healthy skin, as is poor
thru intact epidermis,
but when epidermis
removed, bioavailability is 75%. Is
morphine absorbed
systemically rather than
locally?
Type of Study
Sample
Intervention(s)
Spiegelbergs
phenomenologic
al method
descriptive,
qualitative
Non-probability,
purposive sample of 8
respondents, 4 with
PrU & 4 with previous
PrU (Stage II-IV). Four
had SCI & 5 had
surgical flap
reconstruction; 2 had
MS, 1 was bipolar,
alcoholic, & 1
degenerative
neuromuscular
disorder. Males=7,
female=1, mean age
35.7 year, range 27-52
year. 6 of 8 had
multiple PrU, all 4
current patients with
PrU were Stage IV
N=46
50% male, 50% female
Inclusion: heavily
exudating leg ulcer
Exclusion: sensitivity
to GFD-N, history poor
adherence, arterial
ulcer, required wound
filler on enrollment
Pre- Post,
Prospective open
label
comparative
study.
168
Results
equally well.
7 themes emerged: perceived etiology
of PrU, life impact & changes (physical,
financial & social), psycho-spiritual
impact (body image changes, struggle
with stereotypes, desire/struggle for
control & independence, spiritual
impact), extreme painfulness with PrU
(pain Intensity & duration, analgesic
use), need for knowledge &
understanding (knowledge of
prevention, physiologic processes &
lack of knowledge), need for & effect
of numerous stressful treatment (selfcare, treatment regimens & multiple
surgeries, complications, length of
healing time), & grieving process
(denial, depression, anger, bargaining,
acceptance).
Mean pain VAS intensity rating >50%
for 1st clinic dressing change compared
to pre-study (4.7 v 23, p<.001) & on
removal (3.9 v 1.7, p<.001). Periwound skin condition better for 31%
(p=0.006). GFD-N dressing associated
with SSD in ulcer pain with dressing
in place & during removal. Of 46
subjects, 11% healed the ulcer & 78%
improved in 4 or < wks.
GFD-N was safe, effective &
convenient for wound healing,
exudates management, pain/comfort
& ease of use.
Limitations
Limited to Caucasians,
young or middle age, in
Midwest area of US.
Need replication in
other ethnic groups &
urban areas. Not
followed longitudinally.