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Year : 2018  |  Volume : 24  |  Issue : 2  |  Page : 83-87

Determinants of holistic outcome in traumatic tympanic membrane perforation

Department of E. N. T. and Head-Neck Surgery, U. P. University of Medical Sciences and Associated Hospitals, Saifai, Uttar Pradesh, India

Date of Web Publication4-Sep-2018

Correspondence Address:
Dr. Hemant Ahluwalia
Associate Professor in E.N.T., 140, Defence Estate-1, Gwalior Road, Agra - 282 001, Uttar Pradesh
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/indianjotol.INDIANJOTOL_138_17

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Objective: The goal of this study is to understand the perforation closure dynamics and to elucidate the factors playing vital role in closure of traumatic tympanic membrane perforation (TMP). Study Design: This was a prospective, sequential allocation, three armed, January 2015–June 2017 (30 months). Setting: This study was conducted at university teaching tertiary hospital. Sample Size: A sample size was 309 (291 patients and 294 ears). Results: The total number of patients included was 291 and the total ears were 294 being bilateral traumatic TMPs in three patients. The mean age of the patients was 27.9 years. Hearing loss and bleeding from ear were the most common presentation. In majority, the hearing loss was conductive. Slap being the most common etiology. Posteroinferior quadrant was the most common site of injury. The overall mean closure time of this study was 13.32 days. Three patients were lost to follow-up. Perforation healing rate in this study was 98.98% at 1 month, and there was a significant difference in healing rate for small and large perforations. We have studied all the three variables together, i.e., the impact of time of initiating treatment after injury, grade of perforation, and their closure time to understand the closure dynamics of traumatic TMPs which is unique and is first of its kind in literature. Conclusion: The carbolic acid to the edge and paper patch with soframycin is a noninvasive, patient-friendly and low-cost office procedure for traumatic TMP's and if performed within 72 h of injury gives 99%–100% closure rate.

Keywords: Carbolic acid, closure failure, closure time, patch treatment, perforation healing rate, traumatic tympanic membrane perforation, tympanometry

How to cite this article:
Ahluwalia H, Narain P, Ahluwalia A, Singh J, Singh A. Determinants of holistic outcome in traumatic tympanic membrane perforation. Indian J Otol 2018;24:83-7

How to cite this URL:
Ahluwalia H, Narain P, Ahluwalia A, Singh J, Singh A. Determinants of holistic outcome in traumatic tympanic membrane perforation. Indian J Otol [serial online] 2018 [cited 2021 Jul 30];24:83-7. Available from: https://www.indianjotol.org/text.asp?2018/24/2/83/240566

  Introduction Top

Traumatic perforations of the tympanic membrane (TM) are said to heal spontaneously. If this is the outcome, why the literature is full of plethora of techniques and studies to treat traumatic TM perforation (TMP). The incidence of traumatic perforation is increasing due to changing socioeconomic fabric,[1] and the fast pace of life though it is underreported due to its medicolegal consequences and insurance issues in developing countries. The treatment protocol for traumatic perforation has come a long way from masterly inactivity to embryonic stem cells.

Failure of traumatic TMP to heal can limit the participation in water sports, recruitment in armed forces, railway, and motor driver services and is of socioeconomic significance as it leads to a hearing loss up to 50 dB.

Traumatic TMP can be a result of (a) sudden pressure change due to (i) slap, fight, boxing assault, road traffic accident, water and ball sports injury, kiss (causing negative pressure), nitrous oxide anesthesia, hyperbaric oxygen treatment, (ii) industrial thermal injury such a welding and molten metal blast injury, firecrackers, explosives, lightening (iii) fluid pressure as in-ear syringing, suctioning, and caloric test (iv) barotrauma as in diving, flying in unpressurized cabins. (b) caustic and chemical burn from H2O2(c) instrumentation–”Q-tip injury” (cotton swab), pin, probing, foreign body removal, and  Eustachian tube More Details inflation.

The modalities used for stimulating the proliferation of epithelial cells and fibroblasts at perforation edge along with its vascular regeneration, to shorten the closure time are gel foam patch, chemical cautery, insulin solution, blood preparations, sea buckthorn oil, basic fibroblast growth factor (FGF), epidermal growth factor, hyaluronidase, paper patch, steri-strips, drug-loaded patches, silver foil, and silicon sheet.

This study attempts to analyze the trauma mechanism, perforation characteristics, impact of scaffold, and carbolic acid at different time intervals on the mean closure time (MCT) and the various factors facilitating the early closure leading to cent percentage success rate in traumatic TMPs.

  Materials and Methods Top

A prospective study was conducted at the Department of E. N. T. and Head-Neck Surgery, U. P. University of Medical Sciences and Associated Hospitals, Saifai, Etawah, India from January 2015 to June 2017 over a period of 30 months. Study participants were recruited from the consecutive patients diagnosed with traumatic TMP who presented to the department's outpatient clinic.

The study was reviewed and approved by the ethical committee of the institution and was conducted in compliance with Helsinki Declaration.

A total of 309 patients of traumatic TMPs were sequentially allocated to this study. Out of which, 18 patients were diagnosed to have pinhole TMP which were bound to heal spontaneously. They were subjected to endoscopy and 1% carbolic acid application along with conservative treatment and were excluded from the study. Thus, the total number of cases who participated in this study remains 291. The inclusion criteria to enter in this study were (i) dry traumatic perforation of any etiology (ii) of any size,-small to sub-total (iii) in otherwise healthy TM (iv) ready to follow the format of study, and (v) willing to give informed consent. The exclusion criteria were (i) associated otorrhea or otitis media, (ii) myringosclerosis, (iii) ossicular discontinuity, (iv) severe vertigo, (v) history of prior middle ear disease, and (vi) profound hearing loss.

Otoscopy, pure tone audiometry (ALPS, AC-40, India), endoscopic evaluation of the traumatic TMPs along with application of 1% carbolic acid to the free edge (margin) of perforation and placement of paper patch after putting a drop of soframycin ointment (oil based) on the patch. It was done at an earliest as soon as the patient reports. Endoscopic examination was repeated on 7th, 14th, 21st, and 30th day of patch application. The patch was removed at the end of 3 weeks in endoscope guidance, and the study was abandoned at 1 month from the day of the patch application.

Patients undergoing treatment were prescribed oral antibiotics, nasal decongestant, antihistamine, zinc, and Vitamin C supplement with an advice to prevent water in external auditory canal (EAC), blowing nose, and nose pinching along with blowing.

The acoustic impedance (Interacoustics-A/S, Denmark) was carried out in acoustically treated room on the 7th and 14th day of patch application to confirm the perforation closure. The ears were not monitored daily, closure observed at a particular monitoring time was assumed to have occurred during the time elapsed since the previous impedance time. Perforation closure, i. e., closure time was assessed by tympanometry when the patch was in situ and was confirmed by endoscopic examination of TM once the patch was taken out on 21st day.

No histological study was incorporated as paper patch was used as a scaffold which prevented us to assess the pathological changes at the epithelial edge.

  Results Top

The total number of patients included was 291, and the total ears were 294 being bilateral traumatic TMPs in three patients (one assault and two road accidents). Females outnumbered males constituting 64.3% the majority of it was contributed by female victims of slap injury inflicted by their spouse. The left ear was injured more as a right-handed person tends to slap over the left ear [Table 1]. The mean age of the patients was 27.9 years [Table 2]. Hearing loss was the predominant symptom. Conductive hearing loss in the range of 26–35 dB constituted the majority while sensorineural hearing loss (SNHL) was observed in traumatic TMPs due to explosives, firecrackers, lightening, and electric shock. Bleeding from the ear stood as the second most common symptom [Table 3]. The slap was the most common etiological factors for traumatic TMPs in this study [Table 4]. [Table 5] depicts the various causes of slap and assault which resulted in perforations. Medium sized (46.6%) and triangular shaped (34.4%) perforations were the most common [Table 6] and [Table 7]. Posteroinferior followed by anteroinferior quadrants were most commonly injured. The edges of the perforation were ragged in majority (78.23%), inverted in 13.60%, and everted in the remaining cases. No case developed ear infection during study.
Table 1: Demographic data of the patients in this study (patients-291 and ears-294)

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Table 2: Age-group profile of the patients

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Table 3: Clinical presentation of patients

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Table 4: Etiology of traumatic tympanic membrane perforation

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Table 5: Source of slap (n-163=138+25)

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Table 6: Size of the traumatic tympanic membrane perforation

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Table 7: Shape of the traumatic tympanic membrane perforation

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[Table 8] depicts the number of ears treated at different point of time from sustaining injury and the MCT of that group of perforations. In [Table 9], perforations reported on particular day or period were reclassified according to the grade of perforation to have a more detailed insight. Grades to the size of the perforation were allocated as small (Grade I)- <1 quadrant, medium (Grade II)-one to two quadrant, large (Grade III)-two to three quadrants and subtotal (Grade IV)- >3 quadrants.
Table 8: Number of ears treated at different points of time and their closure time

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Table 9: Correlation between size of perforation, time of treatment, and their closure time

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MCT has shown statistically significant difference when the perforations were treated after 3 days of sustaining injury. Grade IV perforations always had the longest closure time regardless of the time of initiating the treatment. Grade I and II perforations have equivalent closure times when treated within 3 days of injury. Three traumatic TMPs never healed till 30th day (on the day of completion of study) of sustaining injury and as they were included in calculating the MCT; therefore, MCT is even >21 days in those groups. The overall MCT of this study was 13.32 days. Three patients were lost to follow-up and were not included in MCT calculations. Perforation healing rate in this study was 98.98% at 1 month, and there was a significant difference in healing rate for small and large perforations [Table 9].

  Discussion Top

This is the first study of its kind, in which a scaffold (paper patch) was used with an application of 1% carbolic acid to the perforation edge along with soframycin (antibiotic ointment) which has dramatically increased the healing rate of traumatic TMPs. We have studied all the three variables together, i.e., impact of time of initiating treatment after injury, grade of perforation and their closure time to understand the closure dynamics of traumatic TMPs which is unique and has not been done to date in literature to the best of our knowledge.

Factors incorporated in this study to achieve the complete healing rate were (i) use of scaffold (ii) maintaining moisture balance at a perforation edge (iii) maintaining optimum acidic pH at the edge of perforation, (iv) use of antibiotic ointment locally to further reduce the risk of getting the ear infected during study, and (v) use of tympanometry on 7th and 14th day of study to confirm the closure of perforation with patch in situ.

Pure tone audiometry revealed a conductive hearing loss that was (a) greatest at lower frequencies and decreases as the frequency increases (b) directly proportional to the size of the perforation (c) not related to the quadrant of perforation, (d) and inversely varied with the middle-ear volume. Identical perforations in two different ears can have a conductive loss that can differ by up to 20–30 dB if the volume of middle ear differs due to transtympanic sound pressure difference.[2]

SNHL in traumatic TMPs from blast as well as nonblast injury are found in high frequencies as seen in two out of the three explosive cases and has a worse prognosis. SNHL occurs as a loss in several adjacent frequencies or separate dips typically at 4 kHz (”c5 dip”) or 6 kHz (”fis5 dip”).[3] The positive pressure wave of explosion blast and negative pressure generated by a kiss rupture a TM. 35 kPa is the minimum pressure required to rupture a TM. A sudden increase or decrease of air pressure in the canal can cause a rupture of TM, in addition, direction of blast wave, intensity, duration of pressure change, age of patient, architecture of TM, configuration of TM to ossicles, degree of aeration of temporal bone, functional status of Eustachian tube, and presence of wax in EAC plays an important role in the development of traumatic TMPs.[4]

With progress in regenerative medicine research, treatment methods have some similarities between traumatic TMP and skin wound. A moist wound environment hastens the healing of both acute and chronic wounds. The balance of moisture provides an increased electrical gradient which increases the density of platelet-derived growth factor (PDGF) and fibroblast-derived growth factor receptors on fibroblasts, including normal functioning of excitable tissue left-right patterning, organogenesis, and wound healing. The animal studies have shown that this natural electrical gradient increases PDGF and FGF receptor density on fibroblasts, thereby enhancing healing rates.[5]

Moist perforations have a significantly shorter closure time and a better closure rate than dry perforations.[6] A recent study has shown that TM healing was effected by the environmental pH.[7] 1% carbolic acid is having an acidic pH of 5 and an antibiotic ointment soframycin is also acidic to pH. Their synergistic effect further drops the pH to 4 at the perforation edge. Carbolic acid being hygroscopic retain and entraps water under a thin biofilm of soframycin ointment which protects the perforation edge from getting dried. It also performs the cauterization of edge to destroy the yellow abnormal epithelium, thereby accelerating the centripetal epithelial migration. An acidic pH inhibits the bacterial growth, decreases proteolytic activity, ensures stronger and more regular fibroblastsin vitro and provides more oxygen support, thereby decreasing the closure time of perforation. After 7 days, Akkoc et al. found that closure was successful in 5 out of 5 cases at pH 4, in 1 out of 5 at pH 7.[7]

Eardrum bridge is defined as remnants of the eardrum in the area of perforation that is connected by the remnants of eardrum on both sides of the corresponding perforation edge. A sudden increase in air pressure within the EAC can cause the formation of an eardrum bridge. Eardrum bridge appears usually in small and medium perforations and is conspicuously absent in large perforation. Eardrum bridge often becomes necrotic, may become incorporated in the new eardrum, may result in retraction pocket or atrophy of neo-TM; however, the development of middle ear cholesteatoma is still questionable.

Paper patch acts as a scaffold by abutting the perforation edge for epithelial migration to promote the proliferating granulation tissue and aligns the epithelial migration to be centripetal rather than centrifugal which shortens the closure time. With time delay (8–10 days), the proliferation get delayed and so was the closure time. Patch could hasten the healing time, especially of large traumatic TMPs. It is inferred that the patch treatment has to be completed within 3 days of injury and may be within a week with explained prognosis. Small perforations tend to heal even if the patient presents late but large perforations attract failure if not managed within early phase.

The regeneration of traumatic TMP is a complex process and is characterized by various phases, i.e., epithelial proliferation, epithelial migration, fibroblast proliferation, angiogenesis, and tissue remodeling.[8] Following the TM rupture, the curled edge is tension free and is easily subject to contracture, whereas wound healing requires interaction of tension-free tissues.[9] Due to acoustic vibration of annulus tympanicus and the tension of residual eardrum, the curled edges retract continuously along annulus and the handle of malleus, thereby restoring the initial geometric characteristics of perforation.[10]

A study of the effects of embryonic stem cells in traumatic TMPs in Mongolian gerbils found that 100% of TMPs achieved closure with embryonic stem cells after 5 days, compared with only 20% in the physiological saline group [11] and thus it holds a promising future in the treatment of traumatic TMPs.

Therefore, the determinants of the holistic outcome of traumatic TMPs to accelerate the closure rate for shortening the closure time are (1) How early the treatment was given after injury in traumatic TMPs-preferably with in 72 h. Earlier the treatment, higher the perforation closure rate and shorter the perforation closure time. (2) Role of acidifying the pH at perforation edge.(3) Use of scaffolding material for edge approximation, thereby enhancing the centripetal epithelial migration. Inverted edges result in centrifugal migration of proliferating epithelium resulting in closure failure. (4) Application of an oil-based antibiotic ointment on scaffold to prevent infection and to further acidify the edge (5) Eardrum Bridge in perforation (6) Topical application of exogenous FGF or epidermal growth factor (7) Blood clot facilitate TM regeneration.[6] No attempt should be made to remove the blood/blood clot from perforation as it makes an excellent surgical dressing.(8) Minimum period for which the scaffold should be in place to enhance the closure rate is 21 days. (9) Zinc and Vitamin C supplement.

Measurement indicators were perforation closure rate and MCT at 1 month. The perforation size was the only significant determining factor for closure time. This study was concluded at 1 month of patch application, and we assumed that if healing does not complete till 6 weeks of injury, it is closure failure and the patient has to be operated on by myringoplasty.

Rate of spontaneous healing of traumatic TMPs varies from 4.1% (large perforations) to 85.6% (small perforations).[12] Waiting period for the spontaneous healing is quite long and varies even up to 6 months which predisposes the traumatic perforation to get infected in hot and humid climate resulting in otitis media. We do not believe in the concept of spontaneous healing of traumatic TMPs except pinhole perforations. The application of carbolic acid to the edges and paper patch regardless of the size of perforation is a noninvasive, patient-friendly, and low-cost office procedure and if performed within 72 h of injury not only give 99%–100% closure rate but also can save a surgical procedure, i.e., myringoplasty.

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Conflicts of interest

There are no conflicts of interest.

  References Top

Ahluwalia H. Scenario of hearing loss in North and South India. Hear Int (Japan) 1999;82:5.  Back to cited text no. 1
Gulya AJ, Glasscock ME. Glasscock-Shambaugh Surgery of Ear. 5th ed. Spain: BC Decker Inc.; 2003. p. 400-20.  Back to cited text no. 2
Hempel JM, Becker A, Mòller J, Krause E, Berghaus A, Braun T, et al. Traumatic tympanic membrane perforations: Clinical and audiometric findings in 198 patients. Otol Neurotol 2012;33:1357-62.  Back to cited text no. 3
Berger G, Finkelstein Y, Avraham S. Patterns of hearing loss in non-explosive blast injury ear. J Laryngol Otol 1997;111:1137-41.  Back to cited text no. 4
Falanga V, Bourguignon LY. Electrical stimulation increases the expression of fibroblast receptors for transforming growth factor-beta. J Invest Dematol 1987;88:488.  Back to cited text no. 5
Lou ZC, Lou ZH. A moist edge environment aids the regeneration of traumatic tympanic membrane perforations. J Laryngol Otol 2017;131:564-71.  Back to cited text no. 6
Akkoc A, Celik H, Arslan N, Demirci S, Hucumenoglu S, Caydere M, et al. The effects of different environmental pH on healing of tympanic membrane: An experimental study. Eur Arch Otorhinolaryngol 2016;273:2503-8.  Back to cited text no. 7
Ishibashi T, Shinogami M, Ishimoto SI, Yoshida K, Kega K. Induction of KGF, basic FGF and TGF alpha M rna expression during hearing of experimental TM perforations. Acta Otolaryngol 1998;118:701-14.  Back to cited text no. 8
Li J, Eriksson PO, Hansson A, Hellström S, Ny T. Plasmin/plasminogen is essential for the healing of tympanic membrane perforations. Thromb Haemost 2006;96:512-9.  Back to cited text no. 9
Desmouliere A, Chaponnier C, Gabbani G. Tissue repair, contraction and the myofibroblast. Wound Repair Regen 2005;13:7-12.  Back to cited text no. 10
von Unge M, Dirckx JJ, Olivius NP. Embryonic stem cells enhance the healing of tympanic membrane perforations. Int J Pediatr Otorhinolaryngol 2003;67:215-9.  Back to cited text no. 11
Sayin I, Kaya KH, Ekizoğlu O, Erdim I, Kayhan FT. A prospective controlled trial comparing spontaneous closure and epifilm® patching in traumatic tympanic membrane perforations. Eur Arch Otorhinolaryngol 2013;270:2857-63.  Back to cited text no. 12


  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9]


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