Collagen-immobilized patch for repairing small tympanic membrane perforations: in vitro and in vivo assays.

Tympanic membrane (TM) perforation is still one of the most common otology complications. New designs of biomaterials, and lately tissue-engineered composites and grafts, have thoroughly revolutionized the management of TM perforation. In this study, we examined a biologically modified collagen-immobilized polydimethyl siloxane patch to repair TM perforation. In vitro potential of the aforementioned patch as a scaffold to support fibroblast cell growth and adhesion was assessed. An in vivo assay of the patch for initiating repair of TM perforations also was investigated. In vitro assay showed that the patch has significantly increased cell adhesion and growth in comparison with unmodified ones (p < 0.05). In vivo study also showed an overall closure rate of TM perforation of 70% and an average gain of 15.75 ± 4.29 dB in air-bone gap. This study shows that the preliminary in vivo evaluation of a modified siloxane patch in humans had promising results and is comparable to existing biomaterial patches.