Efficacy of EGF and Gelatin Sponge for Traumatic Tympanic Membrane Perforations: A Randomized Controlled Study.

Objective: To compare the outcomes of epidermal growth factor (EGF) and gelatin sponge patch treatments for traumatic tympanic membrane perforations.

Study Design: Prospective, randomized, controlled.

Setting: University-affiliated teaching hospital.

Subjects And Methods: In total, 141 perforations encompassing >50% of the eardrum were randomly divided into 3 groups: EGF (n = 47), gelatin sponge patch (n = 47), and observation (n = 47). The edges of the perforations were not approximated. The closure rate, mean closure time, and infection rate were evaluated at 6 months and the related factors analyzed.

Results: A total of 135 perforations were analyzed. At 6 months, the closure rates were 97.8%, 86.7%, and 82.2% in the EGF, gelatin sponge patch, and spontaneous healing groups, respectively ( = .054). The mean ± SD closure time was 11.12 ± 4.60, 13.67 ± 5.37, and 25.65 ± 13.32 days in the EGF, gelatin sponge patch, and spontaneous healing groups, respectively ( < .001). In addition, the presence of infection was not significantly associated with rate of closure in any group.

Conclusions: As compared with spontaneous healing, daily application of EGF and gelatin sponge patching reduced the closure time of traumatic tympanic membrane perforations. EGF treatment had a higher closure rate and shorter closure time but resulted in otorrhea. By contrast, gelatin sponge patches did not improve the closure rate or cause otorrhea but required repeated patch removal and reapplication. Thus, the appropriate treatment should be selected according to patient need.