Abstract
Objective
SurgiSIS is a new bioactive material derived from porcine small intestinal mucosa (SIS). This acellular, easily absorbable collagen matrix promotes early and new vessel growth, and provides scaffolding for the remodeling tissues. This is an inexpensive and ready-to-use alternative to autologous grafts. We evaluated the efficacy, safety, and surgery time of SIS myringoplasty, and compared clinical outcomes with patient's temporalis fascia (PTF) repair in children.
Methods
Prospective, 2-group (SIS, and PTF) randomized, blinded study in a tertiary-care pediatric institution. 82 children for whom tympanic membrane (TM) repair was indicated were randomly assigned to receive either SIS or PTF myringoplasty. Patients and examining physician were blinded to surgical modality. Primary outcomes were the healing of the TM and surgical time; secondary outcome was presence of any reaction or inflammation of the TM. 2-year follow-up was obtained in all enrolled children.
Results
A total of 82 TM (43 in the SIS and 39 in the ATF groups) perforations were treated. There were 42 stable TM closures in the SIS (97.6%) and 37 (94.8%) in the PTF arm. TM closure was higher in the SIS arm, but results were not statistically significant (OR=04, 95% CI 0.12–1.41). SIS myringoplasty yielded reduced surgical time. No clinical evidence of reaction to SIS was encountered.
Conclusions
SIS myringoplasty is a safe and effective method for TM closure in children, with reduced surgical time. As compared with PTF, the SIS myringoplasty is not associated with significant decrease in the incidence of residual perforations.
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