A prospective, randomized, multicenter, controlled study of the safety of Seprafilm® adhesion barrier in abdominopelvic surgery of the intestine

INTRODUCTION: Seprafilm(R) adhesion barrier (Seprafilm(R)) has been proven to prevent adhesion formation after abdominal and pelvic surgery. This article reports safety results, including the postoperative incidence of abdominal and pelvic abscess and pulmonary embolism, from a large, multicenter trial designed to evaluate the safety and effectiveness of Seprafilm(R) for reduction of adhesion-related postoperative bowel obstruction after abdominopelvic surgery. METHODS: A total of 1,791 patients participated in this prospective, randomized, multicenter, multinational, single-blind, controlled study in patients undergoing abdominopelvic surgery, the majority of whom had inflammatory bowel disease. just before closure of the abdomen, patients were randomized to a Seprafilm(R) or no-treatment control group. Patients received an average of 4.4 and as many as 10 Seprafilm(R) adhesion barriers applied to organs and tissue surfaces that sustained direct surgical trauma and to suspected adhesiogenic surfaces. Complications that occurred within the first month after surgery were evaluated. RESULTS: During the safety evaluation period, the difference between the Seprafilm(R) and control groups for the incidence of abscess (4 vs. 3 percent, respectively) or pulmonary embolism (<1 percent in both groups) was not statisticatly significant (P > 0.05). Foreign body reaction was not reported in either group. Fistula (2 vs. < 1 percent) and peritonitis (2 vs. <1 percent) occurred more frequently (P > 0.05) in the Seprafilm(R) group. In a subpopulation of patients in whom Seprafilm(R) was wrapped around a fresh bowel anastomosis, leak-related events, which included anastomotic leak, fistula, peritonitis, abscess, and sepsis, occurred more frequently (P less than or equal to 0.05). There were no other differences in the incidence, severity, or causative relationship of complications between study groups. CONCLUSIONS: This study confirmed the safety of Seprafilm(R) adhesion barrier with respect to abdominal abscess, pelvic abscess, and pulmonary embolism when administered to patients undergoing abdominopelvic surgery. Foreign body reaction was not reported for any patient. However, wrapping the suture or staple line of a fresh bowel anastomosis with Seprafilm(R) should be avoided, because the data suggest that this practice may increase the risk of sequelae associated with anastomotic leak.