A randomized, prospective, controlled, multicenter clinical trial of a sprayable, site-specific adhesion barrier system in patients undergoing myomectomy

Abstract

Objective To assess the safety and effectiveness of a sprayable, site-specific adhesion barrier system (SprayGel; Confluent Surgical, Waltham, MA) for reduction of adhesion formation. Design Prospective, randomized, controlled phase III trial. Setting University clinic (Kiel, Germany) and private clinic (Bordeaux, France). Patient(s) Sixty-six women aged 34.9 years (range, 23–52 years) undergoing laparoscopic or open uterine myomectomy, enrolled over a 15-month period. Intervention(s) Patients were randomized to receive either optimal surgical treatment plus adhesion barrier or optimal surgical treatment alone, followed by second-look laparoscopy. Main outcome measure(s) Initial and second-look laparoscopy procedures were assessed for incidence, extent, and severity of adhesions; all patients were followed for safety analysis. Result(s) When compared with initial surgery, the mean adhesion tenacity score of adhesions seen at second-look laparoscopy was significantly reduced in treatment patients compared with control patients (0.6 vs. 1.7, a 64.7% reduction). Mean adhesion extent score at second-look laparoscopy compared with initial surgery was 4.5 cm 2 vs. 7.2 cm 2, mean adhesion incidence score was 0.64 vs. 1.22. Of 64 patients, 40 (62.5%) returned for second-look laparoscopy. Conclusion(s) This adhesion barrier was safe, well tolerated, and demonstrated efficacy in a population of patients known to be at risk for adhesion formation. There were no adverse effects attributable to the product and no patients in whom it could not be applied.