A prospective, controlled, randomized, multicenter, exploratory pilot study evaluating the safety and potential trends in efficacy of Adhexil

Abstract

Objective: To present a multicenter, reviewer-blinded pilot study evaluating the safety and trends of efficacy of Adhexil, a novel product using fibrin sealant.

Design: Randomized, reviewer-blinded assessment of postoperative adhesion development in women with bilateral ovarian disease.

Setting: Gynecologic clinics.

Patient(s): Women undergoing gynecologic surgery.

Intervention(s): Patients were assessed for incidence, extent, and severity of ovarian adhesions at the first-look laparoscopy (1LL), followed by standard surgical procedure. Ovaries were randomized for application of Adhexil or untreated. A second-look laparoscopy (2LL) was performed to assess postoperative adhesions.

Main outcome measure(s): Safety and efficacy of Adhexil.

Result(s): A trend toward improvement in adhesion incidence was found in the treated ovaries, with 50% (8/16) of adhesion free ovaries in the Adhexil group, versus 31% (5/16) of control ovaries. Similarly, the improvement in the mean American Fertility Society (AFS) score in the Adhexil-treated group from 1LL (6.4 ± 6.8) to 2LL (4.6 ± 6.9) was observed, whereas worsening of adhesions was observed on the control side from 1LL (5.6 ± 5.1) to 2LL (7.1 ± 6.9). No adverse events or serious adverse events considered related to the study product were reported.

Conclusion(s): A clear trend of efficacy for Adhexil reducing the incidence, severity, and extend of adhesions in laparoscopic gynecology surgery, despite the small sample size. The use of Adhexil appears safe. Further exploration of its safety and efficacy in preventing/reducing postsurgical adhesions is warranted.