Treatment of Tympanic

Membrane Perforation Using

Bacterial Cellulose:
A Randomized Controlled Trial

Counselor:
Kolonel CKM (Purn) dr. Budi Wiranto, Sp. THT-KL

Created by:
Shintia Malinda
30101307080
Abstract
Introduction: Promising treatments for tympanic membrane
perforation closure have been studied. Therapies derived from
tissue engineering probably eliminate the need for conventional
surgery. Bacterial cellulose is presented as an alternative that is
safe, biocompatible, and has low toxicity.

Objectives : To investigate the effect on healing of direct

application of a bacterial cellulose graft on the tympanic
membrane compared to the conventional approach with
autologous fascia.
Methods : Randomized controlled trial. Forty patients with tympanic membrane
perforations secondary to chronic otitis media were included, and were
randomly assigned to an experimental group (20), treated with a bacterial
cellulose graft (BC) and control group (20), treated with autologous temporal
fascia (fascia). We evaluated the surgical time, hospital stay, time of
epithelialization and the rate of tympanic perforation closure. Hospital costs
were compared.

40
patients

randomization

20 in an experimental 20 controls treated

group conventionally
(bacterial cellulose (autologous fascia
membrane graft) graft)
 Results: The closure of perforations was similar in both groups. The
average operation time in the fascia group was 76.50 min versus 14.06 min
bacterial cellulose in the group (p = 0.0001).
The hospital cost by the Brazilian public health system was R$ 600.00 for
the bacterial cellulose group, and R$ 7778.00 for the fascia group (p =
0.0001

Conclusion: The bacterial cellulose promoted the closure of the perforation

of the eardrum, proving to be innovative, safe, effective, minimally invasive
and inexpensive.
 Introduction
Promising treatment for closure of the perforated tympanic
membrane has been studied

An alternative material is

Cellulosic polysaccharide  Gelfoam Atelocollagen

obtained by bacterial synthesis.
 Accelerate cellular growth
and tissue differentiation

safe Low toxicity

Cellulosic polysaccharide
(obtained from bacterial synthesis)
 Comparing

direct administration of
bacterial cellulose graph compared with
(BC) on healing of conventional
tympanic membrane procedures with
perforation autologous fascia
 Methode
• tympanic membrane
perforations caused by
Inclussion otitis media

• Patients with marginal

perfotation,damp or
Exclusion cholesteatomatous
perforations
Places
Time
Otolaryngology Service
in a teaching hospital in
Pernambuco state, Brazil From 2013 to
2014.
 40 patients

randomization

20 in an experimental group
20 controls treated conventionally
(bacterial cellulose membrane
(autologous fascia graft)
graft)
The bacterial cellulose graft is produced and supplied by
PolisaTM, an Experimental Center in the city of Carpina,
Universidade Federal Rural de Pernambuco, Brazil.

Bacterial Cellulose
Technical procedure : Control Group
Patients included in the control group received Myringoplasty
with graft temporal fascia performed under general anesthesia

Graft fascia is given to the medial remains of the tympanic

membrane under the maleus and middle ear

And the position is confirmed with gelfoam

fragments

At the end of the procedure, the incision was

stitched on an anatomical plane, and a swathe was
performed

Cephalexin 500 mg, orally, four times daily for 7 days was
prescribed
Illustration
Technical procedure : Experimental group
local anesthesia with xylocaine infiltration (2%
solution) 5.0 ml with vasoconstrictor

The perforated edge is then given a bacterial

cellulose graft placed on top of the perforation

The tympanic membrane will have self-adhesion.

The patient is discharged immediately after the procedure,

and ordered to return to his / her activities unrestricted.
Antibiotics are not prescribed.
 Long
hospital
treatment

Surgical Duration of
time epithelization

Outcome

Duration of
Side effects
closing

Audiometric
curve 60 days
post-treatment
parametric variables were compared with using Student's t
test, while scores were compared by using a chi-squared
test. Mann-Whitney is used to evaluate the amount of
hospital costs

A 95% confidence interval was used, and the statistical

significance was set at p ≤ 0.05.
R
E
S
U
L
T
 Discussion
Conventional TMP
Steps Tympanic membrane
should be replaced
with connective
tissue that has the
pre- surgical post- properties: elastic,
operative treatment operative strong, and have the
clinical follow-up. ability to vibrate
control

Myringoplasty

Tympanic Reconstruct the voice Infection

Membrane transmission control Improve hearing
Regeneration mechanism
 Perforation
‘’success rate with
location the use of BC
membrane was
surgeon’s Perforation
experience size
90%, compared
80% with
autologous fascia’’
success of
the surgery
Type of graft or of the Tubal
graft
used function

Middle ear
mucosal age
state
 obviates the use of
The use of BC
special materials
Avoids membrane
complications

Cost Gelfoam,
Surgical suture
ear pain, material,
Time antibiotics
bleeding,
hematoma Reduction of 13
times in hospital
reduction of a little costs with the
more than 1 h use of BC
(62.44 min) in BC
membrane

no need for additional tests

(hematology and
no need for incisions, cardiology), hospitalization
removal of fascia, or lifting flaps or general anesthesia.
With the use of bacterial cellulose graft in TMP therapy, it
shows safety, innovative, efficient, effective, minimally
invasive and relatively lower prices.

Conclusion
T.H.A.N.K
Y.O.U