OTOLOGY

Predictors for outcome of paper patch myringoplasty in patientswith 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

� 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 mal-

leus, 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 pre-

dictor 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 per-

foration [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 per-

forations smaller than 5 % of the TM without middle ear

disease.

Keywords Tympanic membrane perforation � Chronic

otitis media � Paper patching � Myringoplasty

Introduction

Acute traumatic perforations of the tympanic membrane

(TM) have long been treated with paper patching methods,

which showed high closure rates [1–3]. 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 sur-

gical myringoplasty using fat or fascia. Chronic TM per-

forations 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 pro-

longed otorrhea, large perforation size, atrophic TM,

adjacent myringosclerosis, and defective unknown stimu-

lus factors for the repair. It has been reported that three

principles are required for the office repair of TM perfo-

rations: 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 myringo-

plasty 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 perfora-

tion size [6–9], 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.

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

123

Eur Arch Otorhinolaryngol

DOI 10.1007/s00405-013-2860-y

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. Perfo-

ration 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 TM—perforation

area index (PAI, %)—was calculated.

Surgical technique

Under the operating microscope, 1 % lidocaine with

1:100,000 epinephrine was injected into the posterosupe-

rior ear canal to anesthetize the TM. The edge of the per-

foration 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. Ster-

ilized thin cigarette paper was cut round to a size larger

than the perforated area and coated with ophthalmic anti-

biotic 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 pro-

cedures were performed by a single surgeon in the outpa-

tient 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 per-

foration at the follow-up visits, a new one was reapplied as

above. A healed TM was confirmed when (1) the complete

closure of perforation was observed under the microscope,

and (2) a normal tympanogram was given for further ver-

ification. 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 PAI—1, 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 Mann–Whitney’s U test and Chi-

Square/Fisher’s 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. Post-

operative changes in PTA were assessed using the Wilco-

xon 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 15–81 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 factors—age, sex, the affected

ear, PTA, duration, and causes—showed 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 signif-

icantly 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

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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 1.17–16.57).

No patient had otorrhea or other complications during

the follow-up period. In the success group, pre- and post-

operative PTAs were 28.9 ± 25.1 and 24.7 ± 27.9

(p = 0.001), which means that the hearing improved sig-

nificantly after the closure of perforations. The closure

times were 2–8 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.

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

Table 1 Clinical factors: success versus failure groups

Success

(n = 27)

Failure

(n = 16)

p value

Age

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

C65 years (n = 7) 4 (57.1) 3 (42.9)

Sex

Male (n = 13) 8 (61.5) 5 (38.5) 1.000

Female (n = 30) 19 (63.3) 11 (36.7)

Affected ear

Right (n = 18) 11 (61.1) 7 (38.9) 0.847

Left (n = 25) 16 (64.0) 9 (36.0)

Hearing

PTA (dB) 28.2 ± 24.9 30.0 ± 12.7 0.152

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)

Duration

3 months to 1 year (n = 9) 8 (88.9) 1 (11.1) 0.121

C1 year (n = 34) 19 (55.9) 15 (44.1)

Cause

Chronic otitis media

(n = 30)

19 (63.3) 11 (36.7) 1.000

Trauma or others (n = 13) 8 (61.5) 5 (38.5)

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

Table 2 Patient distributions according to perforation size criteria:

success versus failure groups

Success

(n = 27)

Failure

(n = 16)

p value

PAI = 1 %

B1 % (n = 9) 7 (77.8) 2 (22.2) 0.446

[1 % (n = 34) 20 (58.8) 14 (41.2)

PAI = 2.5 %

B2.5 % (n = 18) 14 (77.8) 4 (22.2) 0.084

[2.5 % (n = 25) 13 (52.0) 12 (48.0)

PAI = 5 %

B5 % (n = 23) 18 (78.3) 5 (21.7) 0.024*

[5 % (n = 20) 9 (45.0) 11 (55.0)

PAI = 10 %

B10 % (n = 34) 24 (70.6) 10 (29.4) 0.058

[10 % (n = 9) 3 (33.3) 6 (66.7)

PAI = 20 %

B20 % (n = 39) 25 (64.1) 14 (35.9) 0.621

[20 % (n = 4) 2 (50.0) 2 (50.0)

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

index (the area of perforation/the area of tympanic membrane 9 100)

* p \ 0.05

Table 3 Tympanic membrane factors: success versus failure groups

Success

(n = 27)

Failure

(n = 16)

p value

Location

Anterior (n = 37) 22 (59.5) 15 (40.5) 0.386

Posterior (n = 6) 5 (83.3) 1 (16.7)

Perforation size

Mean PAI (%) 5.6 ± 8.1 9.7 ± 8.8 0.043*

PAI B5 % (n = 23) 18 (78.3) 5 (21.7) 0.024*

PAI [5 % (n = 20) 9 (45.0) 11 (55.0)

Relationship between the perforation border and the malleus

Away from the malleus (n = 34) 23 (67.6) 11 (32.4) 0.257

Touching the malleus (n = 9) 4 (44.4) 5 (55.6)

Surface of TM

Dried-up (n = 19) 14 (73.7) 5 (26.3) 0.189

Slightly moist with mucus

(n = 24)

13 (54.2) 11 (45.8)

Number of patch applications

Single (n = 28) 16 (57.1) 12 (42.9) 0.295

Multiple (n = 15) 11 (73.3) 4 (26.7)

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, tri-

chloracetic 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 epithe-

lium and incite an inflammatory healing response at the rim

of the perforation. Rim trimming and irritation are impor-

tant 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 [5–8]. 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 perfora-

tions \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 1.17–16.57) means that the likelihood

of treatment failure is 4.4 times more common in patients

who have perforations larger than 5 % of the TM. Mor-

phometric measurement of the area of perforation using

TM photographs and image analysis software may be a

more objective and precise method than manual

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 dem-

onstrated 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 pro-

cedure 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 myrin-

goplasty in selected patients who had dry chronic perfo-

rations smaller than 5 % of the TM without middle ear

disease before considering the other invasive surgical

myringoplasty.

Conflict of interest The authors declare that they have no conflict

of interest.

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