A Safety and Efficacy Study of a Resorbable Hydrogel for Reduction of Post-Operative Adhesions Following Myomectomy

Mettler L *, Hucke J , Bojahr B , Tinneberg H , Leyland N , Avelar R ,


Objectives: This multicenter randomized single-blind study assessed the safety and efficacy of a resorbable hydrogel (‘Hydrogel’) for the reduction of post-operative adhesion formation following myomectomy. Materials and Methods: Women (n 5 71) who were undergoing laparoscopic (67.6%) or laparotomic myomectomy were randomized (2:1) to Hydrogel (sprayed over surgically treated areas prior to wound closure n 5 48) or to control (standard care n 5 23). Patients (38 Hydrogel 20 control) returned 8–10 weeks later for a second look. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method. The primary efficacy measure was the posterior uterus mAFS score. Results: For Hydrogel and control patients respectively Mean±SD mAFS scores were 0.5 ± 1.4 and 0.0 ± 0.0 at baseline and 1.1 ± 1.9 and 2.6 ± 2.2 at the second look. Similarly mean changes from baseline were 0.8 ± 2.0 and 2.6 ± 2.2 (P 5 0.01); 95% confidence intervals for these mean changes were (0.16 – 1.44) and (1.64 – 3.56). Adverse events were reported by 9.6 and 17.4% of Hydrogel and control patients respectively. No intraabdominal infections or post-operative site infections were reported. Conclusion: This 71-patient study provides the first clinical evidence of the safety and efficacy of Hydrogel for the reduction of adhesions following myomectomy