Reduction of adhesions after uterine myomectomy by Seprafilm membrane (HAL-F): a blinded, prospective, randomized, multicenter clinical study. Seprafilm Adhesion Study Group.
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.


METHODS
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.


METHODS
Nineteen institutions across the United States.


METHODS
One hundred twenty-seven women undergoing uterine myomectomy with at least one posterior uterine incision > or = 1 cm in length.


METHODS
Patients were randomized to treatment with Seprafilm or to no treatment at the completion of the myomectomy.


METHODS
The incidence, severity, extent, and area of uterine adhesions at second-look laparoscopy.


RESULTS
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 cm2). No adverse events occurred that were judged to be related to the use of Seprafilm.


CONCLUSIONS
In this multicenter study, treatment of patients 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.
Diamond
M P
MP
Department of Obstetrics and Gynecology, Hutzel Hospital, Wayne State University, Detroit, Michigan 48201, USA.
D000328:Adult; D005260:Female; D006801:Humans; D015994:Incidence; D008567:Membranes, Artificial; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D012086:Reoperation; D016037:Single-Blind Method; D000267:Tissue Adhesions / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control; D014591:Uterine Diseases / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*
D008567:Membranes, Artificial