WASHINGTON – SurgiSIS, a material derived from porcine small intestinal mucosa, can be safely and effectively used for myringoplasty in children, based on data from a prospective, blinded study of 404 patients.
Patients’ tissue is not always available for tympanic membrane repair, and harvesting the graft may increase intraoperative time, said Dr. Riccardo D’Eredita of Vincenza (Italy) Civil Hospital. SurgiSIS (SIS) "promotes early vessel growth, provides scaffolding for remodeling tissues, and is inexpensive and ready to use." He presented the findings at the annual meeting of the American Academy of Otolaryngology – Head and Neck Surgery Foundation.
The material has been used widely in children, and data from previous studies show that SurgiSIS is gradually replaced by host cells, said Dr. D’Eredita. After 30 days, host cells invade SurgiSIS. After 1 year, SurgiSIS is no longer evident, and has been replaced by the patients’ collagen.
In this study, 404 children underwent tympanic membrane repair in 432 ears; 217 were randomized to myringoplasty with SurgiSIS and 215 were randomized to repair using the patients’ own temporalis fascia.
Overall, the group without SurgiSIS had a 97% rate of stable closures and the group with SurgiSIS had a 95% rate. Surgical time was approximately 15 minutes less for SurgiSIS-treated patients, Dr. D’Eredita said.
The researchers assessed the healing of the tympanic membranes over a 10-year period and found comparable reduction of inflammation in the two groups. There were no adverse reactions in the SIS group.
Dr. D’Eredita had no financial conflicts to disclose.