Reduction of de novo postsurgical adhesions by intraoperative precoating with Sepracoat (HAL-C) solution: a prospective, randomized, blinded, placebo-controlled multicenter study. The Sepracoat Adhesion Study Group.

OBJECTIVE

To assess the efficacy and safety of Sepracoat (HAL-C; Genzyme Corporation, Cambridge, MA) solution in reducing the incidence, severity, and extent of de novo adhesion formation at sites without direct surgical trauma or adhesiolysis at the time of gynecologic laparotomy.

DESIGN

Prospective, randomized, blinded, placebo-controlled multicenter study. Patients underwent gynecologic procedures via laparotomy; approximately 40 days later, surgeons assessed their adhesions during second-look laparoscopy.

SETTING

Twenty-three North American institutions.

PATIENT(S): Two hundred seventy-seven women for safety evaluations; 245 women for efficacy studies.

INTERVENTION(S): Intraoperative serosal coating with Sepracoat (treatment) or phosphate-buffered saline (placebo) after opening of the abdominal cavity, after irrigation or every 30 minutes during surgery, and at the completion of surgery.

MAIN OUTCOME MEASURE(S): Incidence, severity, and extent of de novo adhesions to 23 intraabdominal sites.

RESULT(S): The Sepracoat group had a significantly lower incidence of de novo adhesions than the placebo group as assessed by the proportion of sites involved (0.23 +/- 0.02 versus 0.30 +/- 0.02, respectively) and the percentage of patients without de novo adhesions (13.1% versus 4.6%, respectively), as well as significantly reduced adhesion extent and severity. Sepracoat was well tolerated, with a safety profile nearly identical to that of the placebo.

CONCLUSION(S): Sepracoat was significantly more effective than placebo and was safe in reducing the incidence, extent, and severity of de novo adhesions to multiple sites indirectly traumatized by gynecologic surgery via laparotomy.