Regenerative Repair of Chronic Tympanic Membrane Perforations: A RCT to determine efficacy of innovative surgical treatments. (PMH Foundation. ACTRN 12613001338752, CIA Coates).
Current surgical techniques for Tympanic Membrane Perforations (TMP) repair require one hour of theatre time, sophisticated equipment and a general anaesthetic, and result in variable and inconsistent outcomes. New regenerative tissue-engineering with collagen or silk fibroin scaffolds and genetically engineered basic Fibroblast Growth Factor (bFGF) may be a more effective, safer alternative requiring only 6-8 minutes operating time. This study aims to determine the efficacy of alternative surgical treatments on TMP repair.
Eighty children or adults with chronic TMP are randomised into 1) topical bFGF alone, 2) topical bFGF with gelatin foam scaffold, 3) topical bFGF with collagen scaffold, or 4) topical bFGF with silk fibroin scaffold. Patients are seen weekly then at 3, 6, and 12 months. Primary outcome is the closure of the perforation at 12 months. Early results show a high success rate at three months.
Tissue engineering represents an innovative, cost-effective and non-invasive approach to improve chronic TMP repair, thereby improving chronic ear disease outcomes.