Reduction of postsurgical adhesions with Intergel (R) adhesion prevention solution: a multicenter study of safety and efficacy after conservative gynecologic surgery

Objective: To assess the safety and efficacy of the Intergel adhesion preve ntion solution, a 0.5% ferric hyaluronate gel, in reducing adhesions in pat ients undergoing peritoneal cavity surgery by laparotomy with a planned sec ond-look laparoscopy. Design: Randomized, third-party blinded, placebo-controlled, parallel group . Setting: Eleven centers in the United States, and five centers in Europe. Patient(s): Women aged 18-46 years who wanted to retain their fertility. Intervention(s): Patients received 300 mL of Intergel solution (n = 143) or lactated Ringer's solution (n = 138) as an intraperitoneal instillate at t he completion of surgery. Main Outcome Measure(s): At second-look laparoscopy 6-12 weeks later, the p resence of adhesions was evaluated at 24 abdominal sites. Result(s): Patients treated with Intergel solution (n = 131) had significan tly less adhesions compared to controls (n = 134). Adhesion extent and seve rity were also significantly reduced. The American Fertility Society score for adnexal adhesions was reduced 59% in the patients in whom the Intergel solution was used. The safety profile of the patients treated with the Inte rgel solution was comparable to those treated with lactated Ringer's soluti on. Conclusion(s): The Intergel solution was safe and highly efficacious in red ucing the number, severity, and extent of adhesions throughout the abdomen after peritoneal cavity surgery. (Fertil Steril(R) 2001;76:595-604. (C) 200 1 by American Society for Reproductive Medicine).