Safety and efficacy of the porcine small intestinal submucosa dural substitute: results of a prospective multicenter study and literature review.

OBJECT: Dural substitutes are often needed after neurosurgical procedures to expand or replace dura mater resected during surgery. A new dural repair material derived from porcine small intestinal submucosa (SIS) was evaluated in a prospective multicenter clinical study.

METHODS: Between 2000 and 2003, 59 patients at five different institutions underwent dural reconstruction with the SIS dural substitute, with a minimum follow up of 6 months. The primary goals of the study were to assess the efficacy and safety of the SIS dural substitute according to the rate of cerebrospinal fluid (CSF) leakage, infection, and meningitis. Chiari malformation Type I decompression (32 patients) and tumor resection (18 patients) were the most common procedures performed, with 81% of SIS grafts implanted in the posterior fossa or spine. There was one case of a CSF leak (1.7%), two cases of wound infection (3.4%), and no cases of bacterial meningitis (0%) in the 58 patients available for follow up. In both cases of wound infection, the SIS graft acted as a barrier to infection and was not removed. Intraoperatively, a watertight seal was achieved in all 59 cases. On follow-up imaging available in 27 patients there was no evidence of any adverse reaction to the graft or of cerebral inflammation.

CONCLUSIONS: The SIS dural substitute demonstrated substantial efficacy in these patients after a mean follow up of 7.3 +/- 2.2 months. Rates of infection, CSF leakage, and meningitis were comparable to those reported for other dural substitute materials. A lack of adverse reactions to the graft, favorable safety profile, and clinical efficacy all point to the utility of this material as an alternative for dural repair.