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Eur Arch Otorhinolaryngol (2015) 272:297301

DOI 10.1007/s00405-013-2860-y

OTOLOGY

Predictors for outcome of paper patch myringoplasty in patients


with chronic tympanic membrane perforations
Shi-Nae Park Hyo-Min Kim Kyung-Suk Jin
Jae-Hoan Maeng Sang-Won Yeo So-Young Park

Received: 17 October 2013 / Accepted: 4 December 2013 / Published online: 10 December 2013
Springer-Verlag Berlin Heidelberg 2013

Abstract The purpose of the present study is to evaluate


the outcome of paper patch myringoplasty for chronic
tympanic membrane (TM) perforations and to explore the
predictive factors for a successful closure. A retrospective
study was performed in a tertiary referral center. Data of
the patients who met the inclusion criteria were analyzed:
the treatment outcomes and the potential predictive factors
including age, sex, the affected ear, hearing level, duration
of perforation, causes, location and size of perforations,
relationship between the perforation border and the malleus, status of TM surface, and the number of patch
applications. Complete closure was achieved in 27 of the
total 43 subjects. Among the 11 clinical and TM factors,
only the perforation size remained significant as the predictor after multivariable logistic regression (p = 0.029,
OR 4.4). The patients with perforation B5 % of the TM
showed higher closure rate (78.3 %) than those with perforation [5 % (45.0 %). In conclusion, paper patch
myringoplasty showed overall success rate of 62.8 %. In
patients with perforations smaller than 5 % of the TM, the
closure rate was 78.3 %. The predictor of the treatment
outcome was the perforation size. We can try paper patch
myringoplasty first in patients who had dry chronic perforations smaller than 5 % of the TM without middle ear
disease.
Keywords Tympanic membrane perforation  Chronic
otitis media  Paper patching  Myringoplasty

S.-N. Park  H.-M. Kim  K.-S. Jin  J.-H. Maeng  S.-W. Yeo 
S.-Y. Park (&)
Department of Otorhinolaryngology-Head and Neck Surgery,
The Catholic University of Korea College of Medicine,
222 Banpo-daero, Seocho-gu, Seoul 137-701, Korea
e-mail: sypak@catholic.ac.kr

Introduction
Acute traumatic perforations of the tympanic membrane
(TM) have long been treated with paper patching methods,
which showed high closure rates [13]. On the other hand,
controversies often exist about how to treat small chronic
TM perforations without middle ear pathology. Some
otologists prefer paper patching, while others prefer surgical myringoplasty using fat or fascia. Chronic TM perforations are caused by acute or chronic otitis media,
trauma, ventilation tube removal, iatrogenic complications
and others. Although the TM has an ability to regenerate in
acute perforations, the natural healing process does not
occur in some cases due to repeated infection with prolonged otorrhea, large perforation size, atrophic TM,
adjacent myringosclerosis, and defective unknown stimulus factors for the repair. It has been reported that three
principles are required for the office repair of TM perforations: the edges should be everted and de-epithelialized;
inflammatory response should be created by chemical or
mechanical irritants to promote epithelial proliferation;
materials laid over the perforation provide a scaffold to
support epithelial migration [4].
In the previous clinical studies, paper patch myringoplasty for chronic TM perforations has achieved successful
healing in 30 % [5], 55.7 % [6], 66.7 % [7], and 52.2 % [8]
with different methodologies. However, the studies on the
factors that may influence the outcome of this procedure
for chronic perforations have been limited to the perforation size [69], location of the perforations, the time the
perforation has been present, and the age of the patients [6].
The purpose of this study was to evaluate the outcome of
paper patch myringoplasty performed in patients with
chronic TM perforations and to explore the predictive
factors for a successful closure of the perforation.

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298

Materials and methods


Subjects and the potential predictive factors
After obtaining the approval of the institutional review
boards, we retrospectively reviewed the charts of the
patients who underwent paper patch myringoplasty
between July 2002 and December 2012. The candidates for
data analysis were the patients with chronic perforations
that had been present for more than 3 months regardless of
the causes. Paper patch was applied only to the ears
without otorrhea and middle ear/mastoid pathology
checked by otoendoscopy and temporal bone CT scan.
Paper patching itself could be a simple diagnostic test for
the middle ear function. Hearing improved immediately if
the ossicular chain was intact [10]. In addition, only the
patients, who submitted the informed consent after a full
discussion of the possibility of a failure and alternative
surgical options, received this procedure. Audiometric
testing was performed, and pure tone threshold average
(PTA) and air-bone gap were obtained at 0.5, 1, 2, and
3 kHz. Eleven clinical and TM factors were investigated
through the medical records and TM photographs: age, sex,
the affected ear, hearing level, duration of perforation,
causes, location and size of perforations, relationship
between the perforation border and the malleus, status of
TM surface, and the number of patch applications. Perforation size was measured by the morphometric analysis of
TM photograph using NIH ImageJ software (National
Institutes of Health, USA). The percent of the area of the
perforation with respect to that of total TMperforation
area index (PAI, %)was calculated.
Surgical technique
Under the operating microscope, 1 % lidocaine with
1:100,000 epinephrine was injected into the posterosuperior ear canal to anesthetize the TM. The edge of the perforation was wounded and freshened by excising the
marginal epithelial layer with a pick and a cup forceps. The
rim was then irritated mechanically with suction tip. Sterilized thin cigarette paper was cut round to a size larger
than the perforated area and coated with ophthalmic antibiotic ointment containing oxytetracycline and polymyxin
B. It was placed on the TM using an alligator forceps and
made to overlap the perforated margin enough so there
were no gaps between the TM and the patch. All the procedures were performed by a single surgeon in the outpatient office. After the procedures, patients were prescribed
oral antibiotics for 1 week, and followed up every week.
When the patch was detached or displaced from the perforation at the follow-up visits, a new one was reapplied as
above. A healed TM was confirmed when (1) the complete

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Eur Arch Otorhinolaryngol (2015) 272:297301

closure of perforation was observed under the microscope,


and (2) a normal tympanogram was given for further verification. Perforations that did not shrink even after three
trials of patching within 3 months were considered a
treatment failure.
Data analyses
The collected data were analyzed using SPSS 18.0 (SPSS,
Inc., Chicago, IL, USA). The dependent variables were the
outcomes: success and failure. The classification criteria of
age, PTA, and the duration of perforation were set to
65 years, 25 dB, and 1 year, respectively. To determine the
optimal criterion of perforation size that could influence the
outcomes, we tried five different PAI1, 2.5, 5, 10, and
20 %to find the most significant p value. The individual
predictor variables were compared between the success and
failure groups using MannWhitneys U test and ChiSquare/Fishers exact tests where applicable. To control the
potential confounding factors, multivariable analysis was
executed next using logistic regression. All covariates were
included initially, and the final model was chosen with
backward stepwise selection. Odds ratio (OR) and 95 %
confidence interval (CI) were reported as the measure of
the association of the factors with treatment failure. Postoperative changes in PTA were assessed using the Wilcoxon signed rank test in the success group. A two-tailed
p value \ 0.05 was considered to be significant.

Results
The patients who met the inclusion criteria were 43 (30
women and 13 men; aged 1581 years; mean age
49.2 13.9). They underwent paper patch myringoplasty
in 18 right and 25 left ears. Patients chief complaints were
hearing impairment, otorrhea, aural fullness, or tinnitus. In
all cases, the perforations were in the pars tensa. Complete
closure was achieved in 27 patients, and the overall success
rate was 62.8 %. All clinical factorsage, sex, the affected
ear, PTA, duration, and causesshowed no significant
difference between the success and failure groups
(Table 1). Of the five PAI selected for determination of
size criterion, only 5 % PAI was significantly associated
with the outcomes. The patients with PAI B5 % showed
higher closure rate (78.3 %) than those with PAI [5 %
(45.0 %) (Table 2). In addition, the mean PAI was significantly lower in the success group (5.6 8.1 %) than in
the failure group (9.7 8.8 %). Among the other TM
factors, posterior perforation, perforation away from the
malleus, perforation with dry TM surface, and multiple
patch applications showed higher closure rates, but there
was no statistical significance (Table 3). Multivariable

Eur Arch Otorhinolaryngol (2015) 272:297301

299

Table 1 Clinical factors: success versus failure groups


Success
(n = 27)

Failure
(n = 16)

p value

Mean age (years)

47.5 14.2

51.9 13.2

0.145

\65 years (n = 36)

23 (63.9)

13 (36.1)

1.000

Table 2 Patient distributions according to perforation size criteria:


success versus failure groups
Success
(n = 27)

Failure
(n = 16)

p value

Age

C65 years (n = 7)

4 (57.1)

3 (42.9)

Female (n = 30)

8 (61.5)
19 (63.3)

5 (38.5)

1.000

11 (36.7)

Left (n = 25)

11 (61.1)
16 (64.0)

7 (38.9)

0.847

9 (36.0)

2 (22.2)
14 (41.2)

0.446

B2.5 % (n = 18)

14 (77.8)

4 (22.2)

[2.5 % (n = 25)

13 (52.0)

12 (48.0)

0.084

B5 % (n = 23)

18 (78.3)

5 (21.7)

[5 % (n = 20)

9 (45.0)

11 (55.0)

24 (70.6)

10 (29.4)

3 (33.3)

6 (66.7)

25 (64.1)

14 (35.9)

2 (50.0)

2 (50.0)

0.024*

PAI = 10 %

Hearing
PTA (dB)

7 (77.8)
20 (58.8)

PAI = 5 %

Affected ear
Right (n = 18)

B1 % (n = 9)
[1 % (n = 34)
PAI = 2.5 %

Sex
Male (n = 13)

PAI = 1 %

28.2 24.9

30.0 12.7

0.152

B10 % (n = 34)
[10 % (n = 9)

Air-bone gap (dB)

15.4 11.1

17.0 9.7

0.345

PTA B25 dB (n = 24)

18 (75.0)

6 (25.0)

0.063

PTA [25 dB (n = 19)

9 (47.4)

10 (52.6)

3 months to 1 year (n = 9)

8 (88.9)

1 (11.1)

C1 year (n = 34)

19 (55.9)

15 (44.1)

PAI = 20 %
B20 % (n = 39)
[20 % (n = 4)

Duration
0.121

0.058

0.621

Data presented are number (%) of patients. PAI = perforation area


index (the area of perforation/the area of tympanic membrane 9 100)
* p \ 0.05

Cause
Chronic otitis media
(n = 30)

19 (63.3)

11 (36.7)

Trauma or others (n = 13)

8 (61.5)

5 (38.5)

1.000
Table 3 Tympanic membrane factors: success versus failure groups
Success
(n = 27)

Failure
(n = 16)

p value

Anterior (n = 37)

22 (59.5)

15 (40.5)

0.386

Posterior (n = 6)

5 (83.3)

1 (16.7)

Mean PAI (%)


PAI B5 % (n = 23)

5.6 8.1
18 (78.3)

9.7 8.8 0.043*


5 (21.7)
0.024*

PAI [5 % (n = 20)

9 (45.0)

11 (55.0)

Data presented are mean SD or number (%) of patients

logistic regression also revealed that only the perforation


size based on the criterion of 5 % PAI remained significant
as the predictor of treatment outcome with an OR of 4.4
(p = 0.029, 95 % CI 1.1716.57).
No patient had otorrhea or other complications during
the follow-up period. In the success group, pre- and postoperative PTAs were 28.9 25.1 and 24.7 27.9
(p = 0.001), which means that the hearing improved significantly after the closure of perforations. The closure
times were 28 weeks except five patients. Three of them
were cured by 15 weeks after multiple patch applications,
and in the other two patients, healing was confirmed at 16
and 19 weeks because of the delayed follow-ups.

Location

Perforation size

Relationship between the perforation border and the malleus


Away from the malleus (n = 34)

23 (67.6)

11 (32.4)

Touching the malleus (n = 9)

4 (44.4)

5 (55.6)

0.257

Surface of TM
Dried-up (n = 19)

14 (73.7)

5 (26.3)

Slightly moist with mucus


(n = 24)

13 (54.2)

11 (45.8)

0.189

Number of patch applications

Discussion
In the present study, the authors intended to report the
success rate of paper patch myringoplasty for chronic TM
perforations in our clinic and to explore the predictors for

Single (n = 28)

16 (57.1)

12 (42.9)

Multiple (n = 15)

11 (73.3)

4 (26.7)

0.295

Data presented are mean SD or number (%) of patients


PAI perforation area index, TM tympanic membrane
* p \ 0.05

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the outcomes. The use of various artificial membranes and


chemical cautery for the treatment of TM perforations has a
long history. Chemical agents such as silver nitrate, trichloracetic acid, and urea provoke an inflammatory
response to stimulate healing [11]. Goldman reported a
successful closure rate of 64 % using a silver nitrate bead
or a urea ointment patch [12]. CO2 laser has also been used
to trim the perforation margins by Lee et al. [8]. In this
study, we used mechanical method to remove the epithelium and incite an inflammatory healing response at the rim
of the perforation. Rim trimming and irritation are important for myringoplasty because more rapidly regenerating
epidermal layer grows inward and migrates over the slowly
regenerating connective tissue layers, interrupting the
repair process [1, 11].
The overall success rate of 62.8 % in the present study is
similar with or slightly higher than those of the previous
reports [58]. Furthermore, the closure rate was as high as
78.3 % especially in the patients with perforations smaller
than 5 % of the TM. Perforation size has been known to be
the most important factor for paper patch myringoplasty.
Golz et al. [6] have reported the closure rate of 55.7 % in
perforations \5 mm; Dursun et al. [7], 66.7 % in perforations \3 mm; Lee et al. [8], 72.9 % in perforations
\4 mm. In rats, the recovery rate was 94.4 % in small
perforations (\30 % of the TM), while 56.2 % in large
perforations [9]. In our study, perforation size was the only
predictor of the outcomes, which agreed with the previous
reports. The 5 % PAI was considered the optimal grouping
criterion of perforation size that could predict the outcome
most correctly among the various size criteria. The odds
ratio of 4.4 (95 % CI 1.1716.57) means that the likelihood
of treatment failure is 4.4 times more common in patients
who have perforations larger than 5 % of the TM. Morphometric measurement of the area of perforation using
TM photographs and image analysis software may be a
more objective and precise method than manual

Fig. 1 Schematic drawing of 5 % perforation of tympanic membrane

measurement of the greatest diameter of perforation using


the surgical instruments such as hook or drill tips. The
schematic drawing of 5 % perforation of the TM is demonstrated in Fig. 1. Although no significant associations
were found between the other factors and the treatment
outcomes, these results may be rather encouraging from a
different perspective: surgeons can be free from the other
risk factors when performing paper patch myringoplasty.
Even if only a small portion of patients with chronic otitis
media benefit from paper patching, it would be worthy of a
try as a first-choice alternative to surgical myringoplasty
when indicated, because paper patch myringoplasty is a
simple, safe, minimally invasive, and cost-effective procedure performed in an outpatient clinic.
In conclusion, paper patch myringoplasty showed the
favorable success rates: 62.8 % in total and 78.3 % in ears
with perforations smaller than 5 % of the TM. The only
predictor of the treatment outcome was perforation size.
These results suggest that we can try paper patch myringoplasty in selected patients who had dry chronic perforations smaller than 5 % of the TM without middle ear
disease before considering the other invasive surgical
myringoplasty.
Conflict of interest
of interest.

The authors declare that they have no conflict

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