Seprafilm (HAL-F) Reduces Postoperative Adhesions: Initial Results of a Multicenter Gynecologic Clinical Study

The use of Seprafilm, a bioresorbable membrane, demonstrated to reduce postoperative adhesions in animal studies, was examined in human gynecologic surgery using myomectomy performed by 15 surgeons at 18 centers. Patients randomly received Seprafilm wrapped over the entire uterus or no treatment. Postoperative adhesions were evaluated at early second-look laparoscopy by videotape by a blinded independent observer. The anterior and posterior uterine surfaces were evaluated for the number of sites throughout the pelvis adherent to the uterus, as well as severity (filmy, dense/vascular, cohesive), extent (<25%, 26–50%, ≥51%), and area of adhesions. Of 119 women who completed the trial, Seprafilm treated subjects (n = 54) had an overall significant reduction in uterine abrasions versus controls (n = 65) for severity (mean score, 1.94 vs. 2.43, p =.003), extent (mean score, 1.23 vs. 1.68,p =.003), and area (13.25 vs. 18.72 cm,2 p =.011). The mean number of sites adherent to the entire uterine surface in treated women was 4.97 vs. 7.88 in controls (p <.001). Significant reductions occurred on both posterior and anterior surfaces. We conclude that in this human gynecologic trial, Seprafilm significantly reduced postoperative adhesion development. (Sponsored by Genzyme Corp., Cambridge, MA.)