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.

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.