The goal of this study was to evaluate the effects of conservative treatment and fibroblast growth factor (FGF) applied directly or via Gelfoam on the healing of large traumatic tympanic membrane perforations (TMPs) in humans.Study Design
Prospective, randomized, controlled trial.Methods
A randomized prospective analysis was performed between February 2009 and January 2011 for the treatment of traumatic TMPs in humans that affected greater than 50% of the TM. The closure rate, closure time, hearing gain, and rate of otorrhea were compared among the direct application of FGF, FGF via Gelfoam, and conservative treatment.Results
A total of 94 patients were analyzed. The closure rates of large perforations in the direct FGF application, FGF via Gelfoam, and observation groups were 100%, 97%, and 55%, respectively. FGF-treated groups had significantly improved closure rates compared with the observation group (p < 0.05). However, the closure rate did not differ significantly between patients who received FGF only and those who received FGF via Gelfoam (p > 0.05). FGF-treated groups showed shorter mean closure times compared with the observation group (p < 0.05). However, the closure time did not differ significantly between FGF-treated groups (p > 0.05).All perforations were closed within 2 weeks, regardless of the presence of curled edges in the FGF-treated groups.