Preclinical evaluation of Seprafilm bioresorbable membrane.

Abstract

Objective: To characterize Seprafilm bioresorbable membrane and assess its efficacy and safety in reducing adhesions.

Design: In vitro and animal studies designed to provide precise control of tissue trauma and closely approximate clinically relevant conditions in abdominal surgery.

Setting: Experimental laboratories, USA.

Subjects: Experimental animals, principally rats and rabbits.

Interventions: The rat cecal abrasion or sidewall injury model evaluated the efficacy of seprafilm in the presence of blood and irrigation solutions, in multiple layers, under ischemic conditions, and in adhesion reformation. A rabbit anastomosis model tested the effect of the membrane on wound healing, and a series of challenge tests determined its toxicology, immunogenicity, and biocompatibility.

Main outcome measures: Incidence and severity of adhesions; mutagenicity; pyrogenicity; irritation effects; systemic toxicity.

Results: Seprafilm significantly reduced the number of cecal adhesions (p < 0.001) and the number of animals with severe adhesions (p < 0.001) when compared with nontreated controls, even in the presence of bleeding. The membrane also significantly decreased the number of animals with any adhesions (p < 0.001). Seprafilm maintains efficacy when used with excess irrigation solutions, when layered, and under ischemic conditions. Among rats tested for adhesion reformation, the treated group had a significantly larger proportion of adhesion-free animals than the untreated group, 72% versus 28%, (p = 0.007). Seprafilm did not impair wound healing in anastomosis and is nontoxic, nonmutagenic, nonimmunogenic, nonpyrogenic, nonirritating, and biocompatible.

Conclusion: Preclinical studies have shown that Seprafilm is safe and effective in reducing postsurgical adhesions. Seprafilm meets the requirements of an ideal barrier and can be a useful adjuvant in abdominal and pelvic surgery.