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American Journal of OtolaryngologyHead and Neck Medicine and Surgery 32 (2011) 96 99

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Sutureless tympanoplasty using acellular dermis

Anoop Raj, MBBS, MS, Ankush Sayal, MBBS, MS,
P.K. Rathore, MBBS, MS, Ravi Meher, MBBS, MS, DNB
Department of Otolaryngology and Head, Neck Surgery, MAM College and Assoc. LN Hospital, New Delhi, India
Received 10 August 2009

Abstract

Objective: A prospective randomized unblinded controlled trial was conducted by comparing

acellular dermis with temporalis fascia as graft materials in tympanoplasty (type 1) in terms of
operative time, postoperative pain, graft success rate, and audiologic outcome.
Study design: Forty-two patients with (inactive) chronic suppurative otitis media of tubotympanic
type were randomized, matched, and divided equally into 2 groups of 21 each. One group underwent
tympanoplasty (type 1) via transcanal route using temporalis fascia graft and the other using acellular
dermis. Both groups were compared for operative time, postoperative pain, graft success rate, and
audiologic improvement in hearing.
Results: There was a statistically significant reduction in operative time (P b .05) and postoperative
pain (P b .05) in the acellular dermis group. However, there was no statistical difference in graft
success rate (P N .05) and hearing improvement (P N .05) between both the groups.
Conclusion: Results of tympanoplasty using acellular dermis as graft material are comparable to that
using temporalis fascia in terms of graft uptake and hearing improvement. However, tympanoplasty
using acellular dermis has the advantage of shorter operative time and lesser postoperative pain.
2011 Elsevier Inc. All rights reserved.

1. Introduction
Tympanic membrane perforations are commonly seen
by the otologist. It not only causes loss of hearing but
also the patient has to face the embarrassment of a
persistently or recurrent ear discharges. It can be managed
by reconstruction of the hearing mechanism by grafting
the tympanic membrane perforation. The surgery is called
tympanoplasty, which not only gives the patient a dry ear
but also improves the hearing. Since first described by
Berthold [1] in 1878, a host of materials have been used
for tympanic membrane grafting. These include skin,
vein, fascia, perichondrium, dura, fat, and so on [2]. All

Corresponding author. Department of Otolaryngology and Head,

Neck Surgery, MAM College and Assoc. LN Hospital, New Delhi, J-1 (2nd
Floor), Green Park Extension, New Delhi-110016, India. Tel.: +91
9910264564, 011 26191663.
E-mail address: ankushsayal@yahoo.com (A. Sayal).
0196-0709/$ see front matter 2011 Elsevier Inc. All rights reserved.
doi:10.1016/j.amjoto.2009.10.007

these autologous grafts have excellent success rates of

closing the perforation. The most commonly used
autologous graft material is temporalis fascia. However,
this has its own limitations. To harvest it, an incision has
to be made, which often leaves an externally visible scar.
Also, it is difficult to harvest this material in revision
surgery where the fascia has already been used in the
previous operation.
Acellular dermis is an allograft obtained from cadaveric
or donor skin banks that has been processed to reduce its
immunogenicity by decellularizing it and screening it for
HIV, hepatitis B and C, syphilis, human T-lymphotropic
virus type 1, and others. The processing leaves the
basement membrane and the extracellular matrix intact.
Because the tissue is acellular, it does not produce any
antigenic inflammatory response after implantation. The
implanted dermal matrix provides a template for migration,
repopulation, and revascularization of the patient's own
fibroblasts and endothelial cells. It is available in a freezedried form and has to be rehydrated before use (Fig. 1).

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2.1. Operative procedure

Fig. 1. Photograph of acellular dermis 2 4 cm in size.

Originally described for wound grafting in patients with

burns [3,4], acellular dermis is also being used for facial
tissue augmentation, intraoral resurfacing, periodontal and
maxillofacial surgeries [5], and repair of nasal septal
perforation [6]. Use of acellular dermis in ear surgery as a
graft material can reduce donor site morbidity significantly.
A review of literature on the use of acellular dermis as the
graft material in tympanoplasty was done, and we found
that our study was the only prospective study comparing
acellular dermis with temporalis fascia as graft material in
terms of operative time, postoperative pain, graft success
rate, and hearing improvement.

2. Materials and methods

Patients were recruited over 18 months from November
2007 to April 2009 from the otolaryngology clinics. The
study protocol and consent forms were approved by the
research review committee. The study was unblinded.
During the recruitment phase, patients with (inactive)
chronic otitis media of tubotympanic type were screened
and only those patients in the age group of 18 to 50 years
with medium-sized (involving approximately 25%50% of
the tympanic membrane area based on otoscopic examination), central (involving all the quadrants) perforations
were included in the study. After application of the
exclusion criteria (previously failed tympanoplasty, cholesteatoma, chronic otitis media with complication, tortuous external auditory canal, and those with systemic
diseases), the study was discussed with 59 consecutive
patients with a purely conductive hearing loss (less than 40
dB). Of these, 42 patients who agreed (fully informed
written consents were taken) to be a part of the study were
informed about the study design and underwent randomization into 2 groups. The 2 groups were matched for any
confounding factors.

All patients underwent tympanoplasty (type 1) under

local anesthesia via transcanal route and underlay technique.
In the first group, temporalis fascia was used. The graft was
harvested through a separate incision over the superior
attachment of pinna. In the second group, acellular dermis of
0.03 mm thickness was used as a graft material. Acellular
dermis was hydrated in 2 saline baths for 5 minutes each
before use and tailored according to the size of the
perforation. A self-retaining ear speculum was inserted into
the external auditory canal. The margins of perforation were
visualized under the microscope and freshened, tympanomeatal flap was elevated, canaloplasty was done (so that the
entire annulus was visible without changing the position of
the microscope or of the patient's head), and graft placed by
underlay technique. Usual canal packing was done using
gelfoam and antibiotic-coated merocel ear wick. Patients
were prescribed broad-spectrum antibiotics and analgesics
orally for 1 week. All patients were discharged on the same
day. Patients were advised dry ear precautions and regular
follow-up initially after 1 week and then at 3 weeks, 6 weeks,
and at the end of 3 months.
2.2. Operative time
Operative time was kept by an independent nurse and
included the time at which the incision for harvesting the
graft was given till the time of dressing application. This time
did not include the time used for infiltration of local
anesthesia and preparatory time before the surgery. All the
surgeries were done by the same surgeon so that the
operative time could be compared between the 2 groups.
Mean and standard deviation for each group were calculated
and then compared using Levene t test for equality of
variances. Result was statistically significant if value of
significance (P) was found to be less than .05.
2.3. Postoperative pain
Postoperative pain was measured using a visual analog
scale, 6 hours after surgery. By this time, the effect of local
anesthesia had weaned off. Patients were asked to rate their
pain on the visual analog scale from 0 to 10, 0 meaning no
pain and 10 as unbearable pain. Mean and standard deviation
for each group were calculated and then compared using
Levene t test for equality of variances. Result was
statistically significant if value of significance (P) was
found to be less than .05.
2.4. Graft success rate
Graft success rate was measured in terms of closure of
perforation at the end of 6 weeks. This was documented
using a Hopkins straight 0 tele-otoscope and camera. Graft
success rate (percentage) was calculated for each group and
then compared using Fisher exact test. Result was statisti-

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A. Raj et al. / American Journal of OtolaryngologyHead and Neck Medicine and Surgery 32 (2011) 9699

cally significant if value of significance (P) was found to be

less than .05.
2.5. Audiologic assessment
Hearing improvement (gain in air-bone gap) was assessed
at the end of 3 months by comparing the average pre- and
postoperative air-bone gap at 500, 1000, and 2000 Hz for
both the groups. The mean and standard deviation for gain in
air-bone gap in each group were calculated and then
compared using paired t test and Levene t test for equality
of variances. Result was statistically significant if value of
significance (P) was found to be less than .05.

3. Results
Of the 42 patients who underwent the procedure, 2
patients (1 patient from each group) were lost to follow-up.
The remaining 40 patients (20 patients in each group) were
compared in terms of operative time, postoperative pain,
graft success rate, and audiologic outcome.

3.3. Graft success rate

Graft success rate for the temporalis fascia group and
acellular dermis group was 90% and 95%, respectively. In
the temporalis fascia group, there were 2 failures. One of
these developed upper respiratory tract infection followed by
otitis media and the other had failed to follow dry ear
precautions. In the acellular dermis group, there was one
failure and this patient developed upper respiratory tract
infection followed by otitis media. P value was calculated
using Fisher exact test and found to be 1.00 (P N .05), hence
not significant.
3.4. Audiologic outcome
The average gain in air-bone gap (calculated by comparing
the pre- and postoperative air-bone gap on pure tone
audiometry) for the temporalis fascia group and acellular
dermis group was 14.50 6.46 and 17.00 7.67 dB,
respectively. The value of significance (P) was calculated
using paired t test and Levene t test for equality of variances
and found to be .27 (P N .05), hence not significant.
Thus, the results of hearing improvement and graft
success rate were comparable for both the groups (Table 1).

3.1. Operative time

The average operative time for temporalis fascia group
was 47 minutes 10 seconds 6 minutes 10 seconds. The
average operative time for acellular dermis was 28 minutes
15 seconds 3 minutes 50 seconds. t value between the 2
groups was calculated using Levene t test for equality of
variances and found to be 11.87 with a degree of freedom =
38. The value of significance (P) was found to be .000 (P b
.05) and hence significant. Thus, there was a significant
reduction in operative time when using acellular dermis as
graft material.
3.2. Postoperative pain
The average postoperative pain (measured between 0 and
10 using a visual analog scale) for the temporalis fascia
group and acellular dermis group was 6.20 0.57 and 2.77
0.34, respectively. The t value was calculated using Levene t
test for equality of variances and found to be 22.98 with
degree of freedom = 38. The value of significance (P) was
found to be .000 (P b .05) and hence significant. Thus, there
was a significant reduction in postoperative pain when using
acellular dermis as the graft material.

4. Discussion
Various graft materials have been used for tympanoplasty. Yet temporalis fascia continues to be the most
commonly used graft material. This is because temporalis
fascia is harvested from the same postaural incision, is
uniform, is available in adequate amount, and is autologous
in origin. Although temporalis fascia has proven to be
effective, with a success rate of 88% to 95% in closure of
tympanic membrane perforation, its harvesting is limited by
the need for extra equipment, additional effort by the
surgeon, donor site morbidity, and increased operative time.
Acellular dermis is an alternative graft material that is
processed from human cadaveric dermis. It has the
advantages of being acellular and thus free from any host
antigenic response. The implanted dermal matrix provides a
template for migration, repopulation, and revascularization
of the patient's own fibroblasts and endothelial cells. We
selected 0.03-mm-thick acellular dermis as this was similar
to that of temporalis fascia. Acellular dermis has been used
for myringoplasty in a chinchilla model with similar rates of
perforation closure as temporalis fascia and paper patch

Table 1
Comparison of operative time, postoperative pain, gain in air-bone gap, and graft success rate of temporalis fascia vs acellular dermis group

Average operative time

Average postoperative pain (using VAS)
Average gain in air bone gap
Graft success rate
VAS indicates visual analog scale.

Temporalis fascia group

Acellular dermis group

Result

47 min 10 s 6 min 10 s
6.20 0.57
14.50 6.46 dB
90%

28 min 15 s 3 min 50 s
2.77 0.34
17.00 7.67 dB
95%

t = 11.87, significant (P b .05)

t = 22.98, significant (P b .05)
t = 0.27, not significant (P N .05)
Not significant (P N .05)

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99

we believe acellular material can be an effective graft

material in such cases where availability of temporalis fascia
is a problem. Although we took a small number of patients in
this study, the results have been encouraging and larger
studies are warranted before acellular dermis is used
routinely in ear surgeries.

5. Conclusion

Fig. 2. A and B, Postoperative (4 weeks) healed tympanic membranes using

acellular dermis as graft material.

[7,8]. Downey et al [9] have found no histologic difference in

the tympanic membrane formed after repair using temporalis
fascia or acellular dermis. Fayed et al [10] and Fishman et al
[11] have used acellular dermis with graft success rate of
87.5% and 84%, respectively. Studies involving control
groups for comparison have been lacking. Two previous
studies by Benecke [12] and Dan Vos et al [13] have
compared acellular dermis with temporalis fascia for
tympanoplasty and found similar success rates and audiologic outcome. Our study is the first study that compares the
use of acellular dermis and temporalis fascia graft in terms of
operative time, postoperative pain, graft success rate, and
hearing improvement (Fig. 2).
The disadvantages with the use of acellular dermis are the
high cost and need for storing acellular dermis at 2C to 8C.
The price of acellular dermis gets balanced against the
potential benefits in terms of time saved, which in turn
improves the efficiency of the operation theatre in terms of
allowing greater caseload. As the technique does not involve
the use of suture material, the cost per surgery gets reduced
further. In addition to this, there are nonquantified benefits to
the patient in terms of decreased postoperative pain and
morbidity, cosmetic benefits in view of absence of a
postoperative scar mark, lesser chances of infection and
decreased postoperative recovery period during convalescence from a postoperative incision, and loss of work during
this period.
Because there is no need to harvest a tissue graft when
using acellular dermis, we suggest that the operation should
be performed through a transcanal approach. The transcanal
approach has the logical benefits of reduction in potential
morbidity from infection and postoperative pain, as well as
from a cosmetic stand point. We also noted that acellular
dermis is easier to handle and manipulate during surgery as
compared to temporalis fascia, which has a tendency to fold
during insertion and while repositioning the tympanomeatal
flap. Although revision cases were not included in this study,

Acellular dermis is an effective option as a tympanic

membrane graft material and has similar success rates of
tympanic membrane closure as well as postoperative
audiologic results in comparison to temporalis fascia. Its
use can significantly reduce operative time and postoperative
pain and morbidity. It also preserves native tissues and
provides better cosmetic results by avoiding a post aural scar
mark. Its use via transcanal route can transform the
procedure of tympanoplasty into a sutureless technique that
can be performed on a day care basis. We believe that this
graft should be included in the otologist's armamentarium
for tympanic membrane grafting.
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