Riccardo D'Eredità1. 1. Vicenza Hospital, Via del Risorgimento, 30, 35137 Padova, Italy. Electronic address: riccardo.deredita@ulssvicenza.it.
Abstract
INTRODUCTION: A novel bioactive material for tissue graft, derived from porcine small intestinal mucosa (SIS) has been marketed. 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, in comparison with autologous temporalis fascia (PTF) repair in children in a prospective, two-group (SIS and PTF) randomized, blinded study at a tertiary-care pediatric institution. MATERIALS AND METHODS: 404 children with tympanic membrane (TM) repair were randomly assigned to receive SIS or PTF myringoplasty. Primary outcome was the healing of the TM at 6 months. Secondary outcomes were surgical time, and adverse events. Long-term follow-up ranging from 11 to 2 years was obtained in all enrolled children. Audiometric tests as pure-tone thresholds were applied in all patients. The Fisher's exact test and the Kriskal-Wallis test were applied for statistical analysis. RESULTS AND DISCUSSIONS: Four-hundred-thirty-two TM perforations were treated, 217 in the SIS and 215 in the PTF groups. There were 209 stable TM closures in the SIS (96.3%) and 204 (94.8%) in the PTF arm. This difference was not statistically significant (odds ratio=0.4, 95%; confidence interval=0.12-1.41). SIS myringoplasty yielded reduced surgical time. No adverse reaction to SIS was encountered. Audiometric tests revealed no statistically significant difference in the two groups. CONCLUSIONS: SIS myringoplasty is a safe and effective method for TM closure in children with reduced surgical time, as compared to PTF.
RCT Entities:
INTRODUCTION: A novel bioactive material for tissue graft, derived from porcine small intestinal mucosa (SIS) has been marketed. 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, in comparison with autologous temporalis fascia (PTF) repair in children in a prospective, two-group (SIS and PTF) randomized, blinded study at a tertiary-care pediatric institution. MATERIALS AND METHODS: 404 children with tympanic membrane (TM) repair were randomly assigned to receive SIS or PTF myringoplasty. Primary outcome was the healing of the TM at 6 months. Secondary outcomes were surgical time, and adverse events. Long-term follow-up ranging from 11 to 2 years was obtained in all enrolled children. Audiometric tests as pure-tone thresholds were applied in all patients. The Fisher's exact test and the Kriskal-Wallis test were applied for statistical analysis. RESULTS AND DISCUSSIONS: Four-hundred-thirty-two TM perforations were treated, 217 in the SIS and 215 in the PTF groups. There were 209 stable TM closures in the SIS (96.3%) and 204 (94.8%) in the PTF arm. This difference was not statistically significant (odds ratio=0.4, 95%; confidence interval=0.12-1.41). SIS myringoplasty yielded reduced surgical time. No adverse reaction to SIS was encountered. Audiometric tests revealed no statistically significant difference in the two groups. CONCLUSIONS: SIS myringoplasty is a safe and effective method for TM closure in children with reduced surgical time, as compared to PTF.