Comparative study of fibroblast growth factor 2 and ofloxacin ear drops for repairing large traumatic perforations: A randomized controlled study

Abstract

ObjectiveThe objective of this study was to compare the healing outcome of fibroblast growth factor 2 (FGF2), ofloxacin ear drops (OFLX) and spontaneous healing for repairing large traumatic tympanic membrane (TM) perforations. Material and methodsA total of 75 traumatic large perforations with >1/4 of TM were randomly divided into FGF2 (n = 25), OFLX (n = 25), and spontaneous healing (n = 25) groups. The closure rates, closure times, and hearing gains were compared at 3 months. ResultsAt 2 weeks after treatment, the closure rate was 95.8 % in the FGF2 group, 96.0 % in the ofloxacin ear drops group, and 14.3 % in the spontaneous healing group (P < 0.01), respectively. At 3 months after treatment, the closure rate was 100 % in the FGF2 group, 100 % in the OFLX group, and 85.7 % in the spontaneous healing group, no among-group differences were significant (P > 0.05). The mean closure time was 9.69 ± 2.46 days in the FGF2 group, 9.45 ± 2.32 days in the OFLX group, and 30.94 ± 8.95 days in the spontaneous healing group (P < 0.01). The mean ABG was 10.37 ± 2.51 dB for the FGF2 group, 11.01 ± 1.31 dB for the OFLX group, and 10.86 ± 1.94 dB for the spontaneous healing group, no significant difference was found among three groups (P > 0.05). ConclusionsThis study suggested that both FGF2 and OFLX significantly shortened the mean closure time and improved the closure rate compared with spontaneous healing for repairing large traumatic perforations, while the healing outcome wasn't significantly different among FGF2 and OFLX groups.