Anatomic and audiometric outcomes of porcine intestinal submucosa for tympanic membrane repair

Abstract

Objective: Surgical repair of tympanic membrane perforations has been traditionally performed with autologous soft-tissue grafts with high success rates. Newer allografts such as porcine small intestine submucosa (pSIS) have been employed as alternatives to minimize donor morbidity and surgical time, and in cases where autologous tissue may not be available. The comparative anatomic and audiometric success rates of these tissues is still unclear. Study design: Retrospective case–control series of anatomic and audiometric outcomes of autologous soft tissue versus pSIS graft for primary, isolated transmeatal tympanic membrane repair. Methods: Analysis of patients undergoing primary transmeatal tympanic membrane repair with autologous soft tissue or pSIS. Patients with otorrhea, cholesteatoma or retraction pockets, those who had cartilage grafts or ossicular reconstruction, and revision procedures were excluded. Pre- and post-surgery air–bone gaps (ABG) and pure tone averages (PTA) were compared. Graft success was defined as closure of the perforation at 2-month follow-up visit. Results: The success rate for both the autologous soft tissue and the pSIS arm is 93.8%. There was no statistical significance (p < .05) between the post-op ABG, change in ABG, post-op PTA, change in PTA, or graft success rate between the two groups with either lumped cohort or matched-pairs analysis. Conclusions: pSIS grafts are effective for repair of tympanic membrane perforations with hearing outcomes and graft success rates comparable to autologous soft tissue. Lay summary: Repair of tympanic membrane perforations is traditionally done using a soft-tissue graft harvested from the patient at the time of surgery. pSIS is a newer graft material that is equally effective in terms of anatomical and audiometric outcomes. Level of evidence: Level 3b.