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Indian Journal of Otolaryngology and Head & Neck Surgery logoLink to Indian Journal of Otolaryngology and Head & Neck Surgery
. 2023 Apr 8;75(3):1774–1781. doi: 10.1007/s12070-023-03722-4

Factors Influencing the Outcome of Spontaneous Healing of Traumatic Tympanic Membrane Perforation: A Clinical Prospective Observational Study

Tapasya Bishnoi 1,, Sudheer Kumar Marlapudi 1, P K Sahu 1
PMCID: PMC10447838  PMID: 37636775

Abstract

Trauma to the ear is typically attributed to its location in the craniofacial skeleton. TM is prone to rupture, tear, or perforation when traumatized. Etiological factors may be classified according to the pathogenetic mechanisms (air-pressure change, heat, solids, water pressure). Materials & Method: This is a prospective study of 70 patients with traumatic tympanic membrane perforation between January 2019 and December 2022. Inclusion and exclusion criteria applied and results interpreted. Results: Traumatic TM affects all age groups with a mean age of 27.94 ± 4.76 years. Traumatic TM affects all age groups with a mean age of 27.94 ± 4.76 years, with the highest incidence among the middle-aged groups 61.4%. The male-to-female ratio was found to be 1.9:1, with high predominance among male patients (65.7%) with a frequency of 57.1% for slap injury group in our study contrary to others. Spontaneous healing was observed in 88.6% over a follow-up period of 12 weeks in this study. Our study has not shown that associated comorbidities influence healing (P = 0.550). About 45.5% Marginal perforations have not healed in 12 weeks follow-up period as compared to central perforations 5.1%. Conclusion: There is a high predominance of TM perforation among male patients in our study may be attributed to activity. Spontaneous healing is more common. Duration of healing was significantly affected by the size of the perforation with longer duration for large perforations and vice versa. It is observed in this study that the duration of spontaneous healing is longer in blast injuries when compared to other kinds of injuries. A significant proportion of marginal perforations that have not healed in our study may be attributed to annular ligament involvement.

Keywords: Tympanic membrane perforation, Trauma, Rupture, Myingolysis, Eardrum, Bleeding ear, Hearing loss

Introduction

The lifestyle of mankind included trauma as an integral part that affects any part of the body. Trauma to the ear is typically attributed to its location in the craniofacial skeleton [1]. A thin delicate translucent fibrous membrane that separates the external ear from the middle ear is the Tympanic membrane (TM). TM is prone to rupture, tear, or perforation when traumatized. Etiological factors may be classified according to the pathogenetic mechanisms (air-pressure change, heat, solids, water pressure). Hearing loss, ear bleeding, tinnitus, vertigo, and ear pain are common complaints due to trauma that necessitate medical attention by patients. The TM injury can predispose to middle ear infection leading to grave consequences like facial nerve paralysis, formation of cholesteatoma, perilymph fistula, intracranial infections, and may warrant ear and intracranial exploration [1]. Numerous factors have proven to positively or negatively affect an individual's susceptibility to TM rupture and the healing process of perforation. spontaneous perforation closure rate of 80 percent in 760 different cases of perforations was observed in an overview study [2]. The exact spontaneous healing potential of the traumatically ruptured TM of all sorts and sizes is not known. Therefore, it seems relevant to analyze statistically the correlation between different factors affecting the rates of spontaneous myringeal healing. This study is aimed to correlate various etiological factors of traumatic perforation affecting the spontaneous closure of traumatic perforations.

Methods

This is a prospective observational study of 70 patients with traumatic tympanic membrane perforation who presented to the ENT opd & hospital emergency department at Tertiary care hospital, between January 2019 and December 2022. The study population included both military personnel, their dependents, and civilians in the cantonment.

  1. Inclusion criteria
    1. Acute traumatic eardrum perforation results from blunt injuries such as physical blows (slap injury), sports injury (fist strike or ball hit), explosive noise blast injury (Weapon, ammunition, technical aircraft noise injury), and sharp penetrating injury.
    2. Patient with acute tympanic membrane perforation presented within 24 hours of injury
  2. Exclusion criteria
    1. Injury due to multiple trauma such as road traffic accidents, fall from height, burn accidents, and chemical burn injuries were excluded.
    2. Patients with previous middle ear pathologies or operated ears were excluded

At the initial assessment for each patient, the following parameters were recorded as Age, gender, mode of injury, comorbidities, hearing status, site & type of injury, associated symptoms such as earache, hearing loss, tinnitus, vertigo, and nature of any intervention prior to presentation.

Each patient underwent a thorough ear, nose, throat and general physical examination including tuning fork tests. The TM was assessed by an Otoendoscope by a single ENT specialist who is blinded to the study. Perforation size was categorized as per the extent of  involvement of various quadrants of TM as follows [3].

  1. Small perforation:  ≤ 1 quadrant or maximum diameter < 3 mm (Fig. 1),

  2. Moderate perforation:  > 1 quadrant and ≤ 2 quadrants or maximum diameter between 3 and 5 mm (Fig. 2),

  3. Large perforation:  > 2 quadrants or maximum diameter > 5 mm (Fig. 3).

Fig. 1.

Fig. 1

Small traumatic perforation of TM involving one quadrant of TM

Fig. 2.

Fig. 2

Moderate central perforation of TM involving two quadrants of TM

Fig. 3.

Fig. 3

Large central perforation involving more than two quadrants of TM

Standard Pure tone audiometric testing using Resonance r35c high-frequency audiometer was done and Pure tone averages were determined for air and bone conductions at 500, 1000, 2000, and 4000 Hz using a pure tone audiometer.

A conservative management approach was adopted, except for those with bloody or serosanguinous otorrhea who received oral systemic antibiotics to prevent infection. Follow-up visits were scheduled at 2, 4, 8, and 12 weeks to have a uniform baseline assessment, and eardrums were examined endoscopically and findings were recorded.

Results

Our study design is an observational clinical study “To evaluate factors affecting the outcome of spontaneous healing of traumatic tympanic membrane perforation”. The Statistical software namely SPSS 22.0, and R environment ver.3.2.2 were used for the analysis of the data, and Microsoft word and Excel have been used to generate graphs, tables, etc.

Study Design

An observational clinical study “To evaluate factors affecting the outcome of spontaneous healing of traumatic tympanic membrane perforation” (Tables 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13).

Table 1.

Frequency distribution of Age in years

Age in years No. of patients %
 < 20 2 2.9
20–30 43 61.4
 > 30 25 35.7
Total 70 100.0

Mean ± SD: 27.94 ± 4.76

Table 2.

Frequency distribution of gender

Gender No. of patients %
Male 46 65.7
Female 24 34.3
Total 70 100.0

Table 3.

Frequency distribution of Age Vs Gender

Age in years Gender Total
Male Female
< 20 2 (4.3%) 0 (0%) 2 (2.9%)
20–30 31 (67.4%) 12 (50%) 43 (61.4%)
> 30 13 (28.3%) 12 (50%) 25 (35.7%)
Total 46 (100%) 24 (100%) 70 (100%)
Mean ± SD 26.65 ± 5.17 30.42 ± 2.47 27.94 ± 4.77

P ≤ 0.001**, Significant, Student t-Test:

Table 4.

Frequency distribution of comorbidities

Comorbidities Gender Total (n = 70)
Male (n = 46) Female (n = 24)
Absent 34 (73.9%) 20 (83.3%) 54 (77.1%)
Present 12 (26.1%) 4 (16.7%) 16 (22.9%)
Diabetis Mellitus type II 9 (19.6%) 1 (4.2%) 10 (14.3%)
Hypertension 6 (13%) 2 (8.3%) 8 (11.4%)
Other 0 (0%) 1 (4.2%) 1 (1.4%)

P = 0.550, Not Significant, Fisher exact test

Table 5.

Frequency distribution of mode of injury

Mode of injury Gender Total
Male Female
Blast 16 (34.8%) 0 (0%) 16 (22.9%)
Self inflicted 1 (2.2%) 3 (12.5%) 4 (5.7%)
Slap 19 (41.3%) 21 (87.5%) 40 (57.1%)
Sport injury (hit by ball) 10 (21.7%) 0 (0%) 10 (14.3%)
Total 46 (100%) 24 (100%) 70 (100%)

P ≤ 0.001**, Significant, Fisher Exact Test

Table 6.

Frequency distribution of Size of perforation

Size of perforation Gender Total
Male Female
Large 10 (21.7%) 6 (25%) 16 (22.9%)
Moderate 16 (34.8%) 10 (41.7%) 26 (37.1%)
Small 20 (43.5%) 8 (33.3%) 28 (40%)
Total 46 (100%) 24 (100%) 70 (100%)

P = 0.711, Not Significant, Chi-Square Test

Table 7.

Frequency distribution of pure tone audiometry (PTA) findings: Air-Bone (AB) Gap (dB)

PTA findings AB gap (dB) Gender Total
Male Female
< 10 6 (13%) 6 (25%) 12 (17.1%)
10–20 30 (65.2%) 12 (50%) 42 (60%)
> 20 10 (21.7%) 6 (25%) 16 (22.9%)
Total 46 (100%) 24 (100%) 70 (100%)
Mean ± SD 16.72 ± 7.8 15.88 ± 7.91 16.43 ± 7.79

P = 0.671, Not Significant, Student t test

Table 8.

Frequency distribution of duration of healing in weeks

Duration of healing (wk) Gender Total
Male Female
Not healed 5 (10.9%) 3 (12.5%) 8 (11.4%)
Healed 41 (89.1%) 21 (87.5%) 62 (88.6%)
1–5 27 (58.7%) 17 (70.8%) 44 (62.9%)
6–10 11 (23.9%) 2 (8.3%) 13 (18.6%)
> 10 3 (6.5%) 2 (8.3%) 5 (7.1%)
Total 46 (100%) 24 (100%) 70 (100%)

P = 1.000, Not significant, Fisher exact test

Table 9.

Frequency distribution of type of perforation

Type of perforation Gender Total
Male Female
Central 39 (84.8%) 20 (83.3%) 59 (84.3%)
Marginal 7 (15.2%) 4 (16.7%) 11 (15.7%)
Total 46 (100%) 24 (100%) 70 (100%)

P = 1.000, Not Significant, Fisher exact test

Table 10.

Duration of healing in Weeks (Wk) in relation to the size of perforation

Duration of healing (wk) Size perforation Total
Large Moderate Small
Not healed 8 (50%) 0 (0%) 0 (0%) 8 (11.4%)
Healed 8 (50%) 26 (100%) 28 (100%) 62 (88.6%)
 1–5 0 (0%) 16 (61.5%) 28 (100%) 44 (62.9%)
 6–10 3 (18.8%) 10 (38.5%) 0 (0%) 13 (18.6%)
 > 10 5 (31.3%) 0 (0%) 0 (0%) 5 (7.1%)
Total 16 (100%) 26 (100%) 28 (100%) 70 (100%)

P ≤ 0.001**, Significant, Fisher exact test

Table 11.

Duration of healing in weeks in relation to mode of Injury

Duration of healing (wk) Mode of injury Total
Blast Self inflicted Slap Sport injury (hit by ball)
Not healed 5 (31.3%) 0 (0%) 3 (7.5%) 0 (0%) 8 (11.4%)
Healed 11 (68.8%) 4 (100%) 37 (92.5%) 10 (100%) 62 (88.6%)
 1–5 2 (12.5%) 4 (100%) 30 (75%) 8 (80%) 44 (62.9%)
 6–10 6 (37.5%) 0 (0%) 5 (12.5%) 2 (20%) 13 (18.6%)
 > 10 3 (18.8%) 0 (0%) 2 (5%) 0 (0%) 5 (7.1%)
Total 16 (100%) 4 (100%) 40 (100%) 10 (100%) 70 (100%)

P = 0.004**, Significant, Fisher exact test

Table 12.

Duration of healing in weeks in relation to type of perforation

Duration of healing (wk) Type perforation Total
Central Marginal
Not healed 3 (5.1%) 5 (45.5%) 8 (11.4%)
Healed 56 (94.9%) 6 (54.5%) 62 (88.6%)
 1–5 43 (72.9%) 1 (9.1%) 44 (62.9%)
 6–10 9 (15.3%) 4 (36.4%) 13 (18.6%)
 > 10 4 (6.8%) 1 (9.1%) 5 (7.1%)
Total 59 (100%) 11 (100%) 70 (100%)

P ≤ 0.001**, Significant, Fisher exact test

Table 13.

Size of perforation Vs Type of perforation- frequency distribution of patients studied

Size of perforation Type of perforation Total
Central Marginal
Large 8 (13.6%) 8 (72.7%) 16 (22.9%)
Moderate 23 (38.9%) 3 (27.3%) 26 (37.1%)
Small 28 (47.5%) 0 28 (40.0%)
Total 59 (100.0%) 11 (100.0%) 70 (100.0%)

P = 0.0003**, significant, Fisher exact test, large size of perforation is significantly associated with Marginal type of perforation

Descriptive and inferential statistical analysis has been carried out in the present study. Results on continuous measurements are presented on Mean ± SD (Min–Max) and results on categorical measurements are presented in Number (%). Significance is assessed at 5% level of significance.

The following assumptions on data are made, Assumptions: 1. Dependent variables should be normally distributed, 2. Samples drawn from the population should be random, and Cases of the samples should be independent Student t-test (two-tailed, independent) has been used to find the significance of study parameters on a continuous scale between two groups (Intergroup analysis) on metric parameters. Leven`s test for homogeneity of variance has been performed to assess the homogeneity of variance. A t-test is a statistical test that is used to compare the means of two groups. It is often used in hypothesis testing to determine whether a process or treatment actually has an effect on the population of interest, or whether two groups are different from one another with the null hypothesis (H0) is that the true difference between these groups means is zero and the alternate hypothesis (Ha) is that the true difference is different from zero.

Chi-square/Fisher Exact test has been used to find the significance of study parameters on categorical scale between two or more groups, Non-parametric setting for Qualitative data analysis. Fisher Exact test is used when cell samples are very small (Figs. 4, 5, 6).

Fig. 4.

Fig. 4

Small central perforation of TM

Fig. 5.

Fig. 5

Small central perforation at 4 weeks after trauma. Appears congested during the healing process

Fig. 6.

Fig. 6

Healed TM at 12 weeks after trauma

Significant Figures

 + Suggestive significance (P value: 0.05 < P < 0.10).

* Moderately significant (P value:0.01 < P ≤ 0.05).

** Strongly significant (P value: P ≤ 0.01).

Discussion

The tympanic membrane (TM) is the most sensitive pressure transducer in humans with its unique structure. It is vital to sound transmission and a key element in impedance matching for sound traveling from air medium to fluid medium, and the only true closing membrane remaining in the fully developed human fetus. Attributed to TM location in the craniofacial skeleton, it is prone to trauma. Trauma to the tympanic membrane can be caused by overpressure (slap, fight, domestic assault, road traffic injury (RTI)), thermal or caustic burns, and blunt or penetrating injuries such as instrumentations and barotraumas [4]. Acute traumatic TM perforation can heal spontaneously without any complications in the majority [5]. Numerous factors have proven to positively or negatively affect an individual's susceptibility to TM rupture and the healing process of perforation. An overview study observed a spontaneous perforation closure rate of 80 percent in 760 cases of perforations [2]. However potential for spontaneous healing of traumatically perforated TM of all sorts and sizes is not exactly known. Also, there is a huge diversity in the literature regarding the management of traumatic TM perforations and associated injuries. Currently, the therapeutic spectrum ranges from exclusive expectant observation to immediate surgical repair in all cases [2].

Epithelial healing is a complex, dynamic, and biological process governed by various homeostatic factors. Trauma may provide the stimulus for the initiation of such factors and mechanisms. The TM is unique, having air on both the medial and lateral aspects, with no underlying matrix to support cells advancing to close the defect and an epithelial layer on the lateral aspect in a state of continuous physiological movement. Various factors that were studied influence the spontaneous healing of TM perforation including size & location of the perforation, mode of trauma, Wet or dry perforation, patterns and sequence of granulation tissue formation and proliferating epithelium migration, pre-existing tympanosclerosis, coexisting umbo, and malleus injuries, etc., [5]. During the evaluation of traumatic perforation, it becomes a diagnostic dilemma to assess any hearing deterioration as in the majority of cases prior hearing threshold is unknown [6]. So whenever possible it is always advisable to perform an audiogram at a first clinical visit which facilitates comparison during follow-up, for medicolegal purpose, documentation of hearing loss and to rule out any signs of complications due to traumatic perforation.

The two main factors that lead to the failure of spontaneous, primary healing of traumatically induced perforations are TM necrosis and complicating otitis media. Perforations of thermal and chemical origin result in progressive necrosis [7].

Unfavorable hygienic conditions, pre-existing nasopharyngeal infections, and contaminating material introduced into the tympanic cavity with the causative force invariably are associated with the persistence of perforation. In the case of penetrating injuries through the ear canal causing TM perforation caused by blasts, the relative risk of non-healing spontaneously is exponentially high. Infection in injured tissue is a major factor impairing spontaneous wound healing by causing continued inflammation and tissue damage. In the presence of TM perforation, such infection has significantly hampered spontaneous healing demanding early intervention or a surgical repair else resulting in poor outcomes. Risk of infection due to inspection, attempts to clean the external auditory canal by irrigation with water or earbuds, and instrumentation has only increased the risk of introducing infection, facilitating otitis media rather than spontaneous healing. This in fact either delay spontaneous healing or result in the persistence of perforation. Duration of study or follow-up is considerably associated with the rate of spontaneous healing in a fashion that the shorter the duration of follow-up, the lower the rate of spontaneous healing. Spontaneous healing was found to be faster in the younger age group as compared to the older age, however, it was not statistically significant. The location of perforation on the tympanic membrane was considered to be an associated factor earlier, while it is not statistically significant. The larger the size of the perforation, the longer is the duration required for spontaneous epithelisation of the defect. It is consistently established in numerous studies [8].

The mode of injury in traumatic TM perforations appeared to interfere with the spontaneous process of healing and is probably linked to coexisting infection or injury due to a contaminated foreign body. Cholesteatoma and tympanosclerosis were the two major complications observed in the spontaneous healing of TM perforation [5]. However we have not noticed cholesteatoma or vestibular symptoms in our study population. Laterality of trauma to TM was more inclined to the Left ear, which might be explained by high right-handedness among the population. This invariably is true in slap injuries and also explains laterality to the left side in self-inflicted injuries due to poor maneuvering in attempts to clean the ear. Self-inflicted trauma (injury due to hairpin, pencil, match stick, blast injury, or sharp foreign body) was the most commonly identified cause of marginal perforations in this study.

Traumatic TM affects all age groups with a mean age of 27.94 ± 4.76 years, with the highest incidence among the middle-aged groups in contrast to study by Lou et al. [9]. The incidence of trauma was associated with the cause of injury between both ears and sex. The male-to-female ratio was found to be 1.9:1, with high predominance among male patients (65.7%) with a frequency of 57.1% in the slap injury group in our study contrary to others [5, 9]. Spontaneous healing was observed in 88.6% over a follow-up period of 12 Weeks in this study. Associated comorbidities have not been shown to influence spontaneous healing or duration in our study (P = 0.550). About 45.5% Marginal perforations have not healed in 12 weeks follow-up period as compared to central perforations 5.1%.

Since this study focussed on factors affecting the spontaneous healing of traumatic perforation, no intervention was carried out in the study population. Patients were followed up and those requiring intervention were excluded from the study. However, the treatment protocol followed for patients presented with traumatic perforations within 24 h is as follows. A Conservative approach in the form of Wait and watch policy was adopted for these cases. Cases presenting after 24 h of injury were excluded from this study. Non-healing perforations after 12 weeks of observation depending on the status of the middle ear, site, size of perforation, and hearing status. These were managed accordingly with the course of antibiotics or chemical cauterization to freshen the margins of perforation or tympanoplasty on a case to case basis.

Conclusion

It is evident from our study that traumatic perforations of TM are common, however with good prognosis. There is a high predominance of TM perforation among male patients in our study may be attributed to activity. Spontaneous healing is more common. Duration of healing was significantly affected by the size of the perforation with longer duration for large perforations and vice versa. It is observed in this study that the duration of spontaneous healing is longer in blast injuries when compared to other kinds of injuries. A significant proportion of marginal perforations that have not healed in our study may be attributed to annular ligament involvement. Co-existing comorbidities have not significantly influenced spontaneous healing. Almost all traumatic small central perforations have healed in a 12-week follow-up period. Even though hearing status prior to trauma is difficult to ascertain, it is always advised to obtain an audiogram at the first visit to aid in the assessment as well as follow-up. A Conservative approach in the form of Wait and watch policy is adopted as the rate of spontaneous healing in traumatic TM perforations is high.

Declarations

Informed consent

Informed consent was taken from all the involved patients for publication.

Footnotes

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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