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.