Impact of basic fibroblast growth factor on healing of tympanic membrane perforations due to direct penetrating trauma: a prospective non-blinded/controlled study

Objective To investigate the effect of direct application of basic fibroblast growth factor (bFGF) on healing of tympanic membrane perforations due to direct traumatic penetration through the external auditory canal. Design A prospective non-blinded controlled study. Setting University-affiliated teaching hospital. Participants In total, 104 patients with small [<25%] penetrating perforations were recruited. They were alternatively allocated to two groups: Control (spontaneous healing, n = 51) and FGF treatment (direct application of bFGF drops in the clinic and repeated daily by the patient, n = 53). Outcomes Perforation closure rate and time and hearing gain were recorded and compared between the two groups. Information on earache, dizziness and facial paralysis was also collected. Results In total, 93 (89%) patients were finally analysed. The closure rate at 3 m of the perforations in the control spontaneous healing and bFGF treatment groups were 77% and 100%, respectively; the difference was statistically significant (P = 0.01). The average closure time was 43.1 +/- 2.5 days (range, 1757 days) for control patients, which was significantly longer (P < 0.01) than that for the bFGF-treated patients (12.6 +/- 1.2 days; range, 321 days). The mean hearing improvement at 3 m was not significantly different between the FGF treatment and control groups (1.7 +/- 2.4 dB vs 11.5 +/- 1.9 dB, P > 0.05). No significant difference was observed in earache, dizziness and facial paralysis between two groups. Conclusions Direct application of bFGF may offer an effective topical management of penetrating traumatic tympanic membrane perforations, particularly for small-sized perforations.