A Randomised Controlled Trial Comparing Spontaneous Healing, Gelfoam Patching And Edge-approximation Plus Gelfoam Patching In Traumatic Tympanic Membrane Perforation With Inverted Or Everted Edges

Abstract

OBJECTIVE: To compare the outcome of patients with dry traumatic tympanic membrane perforation after spontaneous healing and gelfoam patching with or without perforation edge approximation. DESIGN: Prospective clinical study. SETTING: University-affiliated teaching hospital. PARTICIPANTS: Ninety-one patients with acute dry traumatic tympanic membrane perforation inverted or everted edges were recruited. They were randomly allocated to three groups: spontaneous healing (n=31), gelfoam patching (n=30) and edge-approximation plus gelfoam patching (n=30). Otoscopy and tympanometry were performed before the treatment and at follow-up visits. MAIN OUTCOME MEASURES: Healing rate, healing time, ear infection rate and morphological changes during healing process. RESULTS: The overall healing rate was 85% in the spontaneous healing group, lower than that in the two gelfoam patching groups (97%), but the difference failed to reach a statistical significance (P>0.05). The average healing time was 30 ± 10.1 days in the spontaneous healing group, significantly longer (P<0.01) than that in the other two groups (16 ± 5.6 and 18 ± 4.7 days, respectively). Middle ear infection rate did not differ significantly (7%, 3% and 3%, respectively). Spontaneous healing resulted in formation of scabs at the perforation edges, which was effectively prevented by gelfoam patching. CONCLUSIONS: Gelfoam patching may facilitate healing of traumatically perforated tympanic membrane. Approximation of folded perforation edges is not necessary in gelfoam patching.