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.


METHODS
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.


METHODS
Twenty-three North American institutions.


METHODS
Two hundred seventy-seven women for safety evaluations; 245 women for efficacy studies.


METHODS
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.


METHODS
Incidence, severity, and extent of de novo adhesions to 23 intraabdominal sites.


RESULTS
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.


CONCLUSIONS
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.
Diamond
M P
MP
Hutzel Hospital, Wayne State University, Detroit, Michigan 48201, USA.
D000287:Administration, Topical; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D005831:Genital Diseases, Female / Q000601:surgery; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015994:Incidence; D007430:Intraoperative Care; D007813:Laparotomy; D010388:Pelvis; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D000267:Tissue Adhesions / Q000453:epidemiology / Q000517:prevention & control*; D016896:Treatment Outcome
D006820:Hyaluronic Acid