Evaluation of SprayShield™ Adhesion Barrier in a single center: randomized controlled study in 15 women undergoing reconstructive surgery after laparoscopic myomectomy.

Abstract

The objective of this study was to evaluate the safety and efficacy of SprayShield™ Adhesion Barrier in preventing and/or reducing postoperative adhesion during gynecological surgery. This was a prospective, controlled, blinded, and randomized study. Patient blinding was performed intraoperatively. Subjects were randomly assigned to the SprayShield™ or the control group in a 2:1 ratio. The study was conducted at the Clinic of Gynaecology and Obstetrics, at the University Hospital for Gynecology in Germany. Fifteen patients participated in this study; nine patients were assigned to the SprayShield™ and six patients to the control group. During first operation (FLL) in the SprayShield™ group, the agent was applied to all myomectomy suture lines. Patients in the control group did not receive any anti-adhesion treatment, only good surgical practice. A second-look laparoscopy (SLL) was performed 8-12weeks after myomectomy to evaluate adhesion formation. Main outcome measures were incidence, severity, and extent of uterine adhesions. No significant differences were found between the two study groups. SprayShield™ is easy to use. No serious adverse event related to SprayShield™ was observed. Efficacy data are inconclusive regarding the performance of SprayShield™. Further studies are needed to better understand this performance.