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

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.

RCT Entities:   Population Interventions Outcomes