THE EFFICACY OF INTERCEED(TC7) FOR PREVENTION OF REFORMATION OF POSTOPERATIVE ADHESIONS ON OVARIES, FALLOPIAN-TUBES, AND FIMBRIAE IN MICROSURGICAL OPERATIONS FOR FERTILITY - A MULTICENTER STUDY

Objective: To evaluate the efficacy of Interceed as an adjuvant in the prevention of postoperative adhesion reformation to the ovary, fallop ian tube, and fimbria when used together with microsurgical techniques . Design: Prospective, randomized, multicenter, controlled clinical st udy. Setting: Normal human volunteers in an academic research environm ent. Patients: Sixty-six women suffering from infertility due at least in part to bilateral tubal disease with bilateral adhesions attached to ovaries, fallopian tubes, and fimbriae. Intervention:Adhesiolysis b ilaterly through laparotomy with microsurgical techniques, application of Interceed on one of the sides randomly assigned not known by the s urgeon before application, follow-up laparoscopy 4 to 10 weeks postope ratively, with each patient serving as her own control. Main Outcome M easures: Adhesion severity scores at all sites and number of adhesion free organs after laparotomy and follow-up laparoscopy. Results: When the initial scores registered at the operation for fertility were comp ared with those registered at the second-look laparoscopy, the results indicated that gentle microsurgical techniques resulted in a signific ant reduction of postoperative adhesions. Adnexa, which were covered w ith Interceed, had significantly lower adhesion scores than the contro l adnexa, representing an improvement of 39% compared with microsurger y alone (control) in reducing adhesion reformation scores. When combin ed with microsurgical techniques, Interceed reduced adhesion reformati on scores by 70%. The number of ovaries, fallopian tubes, and fimbriae without adhesions at the time of second-look laparoscopy was signific antly increased by approximately twofold when organs were covered with Interceed. Conclusion: In a prospective, randomized, multicenter, con trolled clinical study using a protocol in which other adjuvants have been shown not to be efficacious, Interceed was shown to reduce signif icantly the incidence and severity of adhesion reformation to the ovar y, fallopian tube, and fimbria after infertility surgery.