1

Introduction

Traumatic tympanic membrane perforation (TMP) is often seen in the otology clinic, and it can result in conductive hearing loss, tinnitus, and middle ear infection . Most traumatic TMPs heal spontaneously ; however, larger perforations are difficult to repair, the reported spontaneous closure rate for large perforations is 38–78.9% and the mean closure time is 8–12 weeks . Controversy persists regarding the treatment of large TMPs. Most otolaryngologists prefer treatment by observation while keeping the ear dry , but others have suggested that early interventions improve the closure rate and shorten the closure time .

Recently, polypeptide growth factors have frequently been used to repair experimental and clinical TMPs with satisfactory effects . Santa et al. found that epidermal growth factor (EGF) played an important role in the healing of wounds in the TM, including a role in keratinocyte proliferation and migration. Topical application of exogenous EGF accelerated the closure of acute TMPs in rats and chronic TMPs in chinchillas ; however, similar effects have not been observed in the clinic for chronic TMP .

This study retrospectively investigated the effects and short-term complications of topical application of EGF and ofloxacin otic drops in human large traumatic TMPs compared with conservative treatment.

2

Materials and methods

This retrospective study was approved by institutional review board of Affiliated YiWu Hospital of Wenzhou Medical University. The patient records/information was anonymized and de-identified prior to analysis. The clinical records of traumatic TMP patients who presented to the Otolaryngology Outpatient Clinic in Wenzhou Medical College-Affiliated Yiwu Hospital from February 1, 2007 to December 31, 2008 were retrospectively reviewed. Cases that met the following inclusion criteria were retrieved for analysis: (1) traumatic TMPs resulting from blunt injuries, such as physical blows (e.g., open-hand slap, fist strikes, or ball hits); (2) a perforation size of at least one quarter of the pars tensa and no middle ear infection or vertigo at the initial visit; (3) no ossicular chain damage, confirmed by computed tomography (CT) of the temporal bone and an endoscopic examination; (4) EGF treatment, ofloxacin drops treatment, or only observation was adopted; and (5) otoendoscopy video images of the healing process were recorded twice weekly until closure of the perforation or the 6-month follow-up assessment. Any patient with pre-existing ear disease or perforation resulting from explosive blasts, direct penetration injury, or chemical injury was excluded. A ‘large’ perforation was defined as one exceeding 25% of the entire TM when viewed using ImageJ software (NIH, Bethesda, MD) .

All of the recorded otoendoscopic video images were imported into a computer for storage. The clinical records were studied to obtain demographic data, cause of injury, duration of injury, size of perforation, secondary purulent otorrhea status, method of repair, closure time, and pretreatment and postclosure hearing levels. Data were subsequently analyzed to determine the outcomes of the techniques used. Pure-tone averages were determined for air and bone conductions at 500, 1000, 2000, and 4000 Hz. Treatment methods and their advantages and disadvantages were carefully described by the clinician when the patients visited the first time. Following these descriptions, patients were divided into three groups based on the patient’s self-selection: observation group, EGF-treated group, and ofloxacin otic drops.

2

Materials and methods

This retrospective study was approved by institutional review board of Affiliated YiWu Hospital of Wenzhou Medical University. The patient records/information was anonymized and de-identified prior to analysis. The clinical records of traumatic TMP patients who presented to the Otolaryngology Outpatient Clinic in Wenzhou Medical College-Affiliated Yiwu Hospital from February 1, 2007 to December 31, 2008 were retrospectively reviewed. Cases that met the following inclusion criteria were retrieved for analysis: (1) traumatic TMPs resulting from blunt injuries, such as physical blows (e.g., open-hand slap, fist strikes, or ball hits); (2) a perforation size of at least one quarter of the pars tensa and no middle ear infection or vertigo at the initial visit; (3) no ossicular chain damage, confirmed by computed tomography (CT) of the temporal bone and an endoscopic examination; (4) EGF treatment, ofloxacin drops treatment, or only observation was adopted; and (5) otoendoscopy video images of the healing process were recorded twice weekly until closure of the perforation or the 6-month follow-up assessment. Any patient with pre-existing ear disease or perforation resulting from explosive blasts, direct penetration injury, or chemical injury was excluded. A ‘large’ perforation was defined as one exceeding 25% of the entire TM when viewed using ImageJ software (NIH, Bethesda, MD) .

All of the recorded otoendoscopic video images were imported into a computer for storage. The clinical records were studied to obtain demographic data, cause of injury, duration of injury, size of perforation, secondary purulent otorrhea status, method of repair, closure time, and pretreatment and postclosure hearing levels. Data were subsequently analyzed to determine the outcomes of the techniques used. Pure-tone averages were determined for air and bone conductions at 500, 1000, 2000, and 4000 Hz. Treatment methods and their advantages and disadvantages were carefully described by the clinician when the patients visited the first time. Following these descriptions, patients were divided into three groups based on the patient’s self-selection: observation group, EGF-treated group, and ofloxacin otic drops.