Biosynthetic graft versus autologous graft tympanoplasty: a prospective randomized controlled trial.

PURPOSE: The aim of this study was to compare the graft success rate, hearing outcome, and operative time in patients undergoing tympanoplasty for tympanic membrane perforation with the use of either biosynthetic or autologous graft material.

METHODS

This was a prospective randomized controlled trial performed at a regional hospital. 41 patients were enrolled and randomized, with 20 patients allocated to the treatment arm (biosynthetic graft) and 21 patients allocated to the control arm (autologous graft). The primary outcome was graft success rate. The secondary outcomes were operative time and hearing outcomes (assessed by pure tone audiogram hearing threshold improvement and closure of air-bone gap at 6 months postoperatively).

RESULTS

There was no statistically significant difference in the graft success rate between the two groups (P = 0.645). There was also no statistically significant difference in the hearing outcomes (hearing thresholds improvement P = 0.886, air-bone gap improvement P = 0.651). However operative time was significantly shorter in the biosynthetic graft group compared with the autologous graft group (45.5 min vs. 72 min respectively; P < 0.001).

CONCLUSION

This study demonstrates that tympanoplasty using a biosynthetic graft material can achieve comparable graft success rate and hearing outcomes as compared with conventional autologous graft tympanoplasty, but with the added benefits of a shortened operative time and avoiding incisions.