Open AccessSurgiSIS Myringoplasty: A 10‐Year Study in Children
Author(s) -
D’Eredita Riccardo
Publication year - 2012
Publication title -
otolaryngology–head and neck surgery
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.232
H-Index - 121
eISSN - 1097-6817
pISSN - 0194-5998
DOI - 10.1177/0194599812451438a216
Subject(s) - myringoplasty , medicine , surgery , tympanoplasty , tertiary care , fascia
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.