Adhesion prevention in gynecological surgery:: preclinical and clinical studies

Background Postsurgical adhesions are a serious postoperative complication of abdomino-pelvic surgical procedures. Hyaluronic acid (HA) and its derivatives have been shown to play an important role in the prevention of postsurgical adhesions. The aim of the present experimental studies was to evaluate the efficacy and the biocompatibility of a hyaluronan (HA) crosslinked derivative (ACP, Fidia Advanced Biopolymers, Abano Terme, Italy) in the form of a gel. Methods. Two preclinical trials were conducted in rabbits to test various preparations of the ACP gel. Animals were subjected to laparoscopy (n = 64) or laparotomy (n = 69). Adhesions were induced with surgical trauma by either abrasion of the uterine horns or dissection of the major vessels of each uterine horn. Animals were randomly assigned to treatment (n = 91) or control (n = 42) groups. The safety of the ACP gel is also being evaluated in two pilot randomized clinical trials that are currently ongoing in patients who require laparoscopic or hysteroscopic surgery. Results. Preclinical results demonstrated that the ACP gel was effective in preventing adhesions. Preliminary data from the clinical trials suggests that the device is well tolerated, with no side effects as yet observed. Conclusions. To date, the preclinical efficacy and clinical safety studies indicate that this ACP gel is a promising antiadhesive device.