Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): A blinded, prospective, randomized, multicenter clinical study

Objective: To assess the safety and efficacy of Seprafilm (HAL-F), Bioresorbable Membrane, (Genzyme Corporation, Cambridge, MA) in reducing the incidence, severity, extent, and area of uterine adhesions after myomectomy. Design: Prospective, randomized, blinded, multicenter study. Adhesion reduction was assessed by an independent, blinded, gynecologic surgeon who reviewed videotapes of each patient's second-look laparoscopy. Setting: Nineteen institutions across the United States. Patient(s): One hundred twenty-seven women undergoing uterine myomectomy with at least one posterior uterine incision greater than or equal to 1 cm in length. Intervention(s): Patients were randomized to treatment with Seprafilm or to no treatment at the completion of the myomectomy. Main Outcome Measure(s): The incidence, severity, extent, and area of uterine adhesions at second-look laparoscopy. Result(s): The incidence, measured as the mean number of sites adherent to the uterine surface, was significantly less in treated patients (4.98 +/- 0.52 [mean +/- SEM] sites) than in no treatment patients (7.88 +/- 0.48 sites) as were the mean uterine adhesion severity scores (1.94 +/- 0.14 versus 2.43 +/- 0.10; treatment versus no treatment, respectively), mean extent scores (1.23 +/- 0.12 versus 1.68 +/- 0.10), and mean area of adhesions (13.2 +/- 1.67 versus 18.7 +/- 1.66 cm(2)). No adverse events occurred that were judged to be related to the use of Seprafilm. Conclusion(s): In this multicenter study, treatment of patient;s after myomectomy with Seprafilm significantly reduced the incidence, severity, extent, and area of postoperative uterine adhesions. Additionally, Seprafilm treatment was not associated with an increase in postoperative complications.