Reduction of postsurgical adhesions with Intergel® 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 prevention solution, a 0.5% ferric hyaluronate gel, in reducing adhesions in patients undergoing peritoneal cavity surgery by laparotomy with a planned second-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 the completion of surgery. Main Outcome Measure(s): At second-look laparoscopy 6-12 weeks later, the presence of adhesions was evaluated at 24 abdominal sites. Result(s): Patients treated with Intergel solution (n = 131) had significantly less adhesions compared to controls (n = 134). Adhesion extent and severity 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 Intergel solution was comparable to those treated with lactated Ringer's solution. Conclusion(s): The Intergel solution was safe and highly efficacious in reducing the number, severity, and extent of adhesions throughout the abdomen after peritoneal cavity surgery. (Fertil Steril(R) 2001;76:595-604. (C) 2001 by American Society for Reproductive Medicine).