Abstract
Objective: SurgiSIS is a bioactive material derived from porcine small intestinal mucosa (SIS). This material promotes early vessel growth, provides scaffolding for the remodeling tissues, and is inexpensive and ready-to-use. We evaluated efficacy, safety, and surgery time of SIS myringoplasty, and compared with patients’ temporalis fascia (PTF) repair in children.
Method: Prospective, 2-group (SIS and PTF) randomized, blinded study in a tertiary-care pediatric institution; 404 children with tympanic membrane (TM) repair were randomly assigned to receive SIS or PTF myringoplasty. Primary outcomes were the healing of the TM and surgical time. Ten years’ follow-up was obtained in all enrolled children.
Results: Four hundred thirty-two TM (217 in the SIS and 215 in the ATF groups) perforations were treated. There were 212 stable TM closures in the SIS (97.2%) and 204 (94.8%) in the PTF arm. TM closure was higher in the SIS arm. Results were not statistically significant (OR = 0.4, 95% CI 0.12-1.41). SIS myringoplasty yielded reduced surgical time. No reaction to SIS was encountered.
Conclusion: SIS myringoplasty is a safe and effective method for TM closure in children with reduced surgical time, as compared to PTF.
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