Comparison of porcine small intestinal submucosa and autologous graft material for repairing tympanic membrane perforation: a systematic review and meta-analysis.

Purpose: To perform a systematic review and meta-analysis exploring the effectiveness of porcine small intestinal submucosa (pSIS) compared with autologous grafts for tympanic membrane perforation repair.

Methods: A prospective meta-analysis protocol was registered on PROSPERO (International Prospective Register of Systematic Reviews) on June 5th, 2024, under protocol CRD42024551979. PubMed, Embase/Ovid and Cochrane Central databases were searched from inception to 28/05/2024 for studies comparing the use of pSIS versus autologous grafts (perichondrium, cartilage, temporalis fascia or cartilage-perichondrium) for tympanic membrane perforation repair. The outcomes evaluated were persistent perforation after surgery, operative time and hearing outcome. Statistical analyses were performed using the online Review Manager (Cochrane Collaboration). A subgroup analyses were carried out for the paediatric population.

Results: We included 1,407 patients (1447 ears) from seven records; six retrospective cohort studies and one randomised controlled trial (RCT). pSIS graft was used in 563 ear surgeries (38.1%). Four studies included children with a mean age ranging from 7.3 to 11.7 years and the other 3 studies included adults with a mean age ranging from 30.8 to 48.4 years. Follow-up ranged from 2 to 132 months. There was no statistically significant difference in the failure rate (persistent perforation) between pSIS graft and autologous graft (RR 0.95; 95% CI 0.67-1.33; p = 0.76). However, reduced operative time was associated with using pSIS grafts (MD -16.12 min; 95% CI -22.94-9.31; p = < 0.00001).

Conclusion: Tympanic membrane perforation repair with pSIS grafts had a similar failure rate and hearing outcome compared to autologous grafts and demonstrated an association with reduced operative time.