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

Tchartchian, Garri; Hackethal, Andreas; Herrmann, Anja; Bojahr, Bernd; Wallwiener, Christian; Ohlinger, Ralf; Ebert, Andreas D; De Wilde, Rudy Leon

OBJECTIVE The objective of this study was to evaluate the safety and efficacy of SprayShieldâ„¢ Adhesion Barrier in preventing and/or reducing postoperative adhesion during gynecological surgery. DESIGN This was a prospective, controlled, blinded, and randomized study. Patient blinding was performed intraoperatively. Subjects were randomly assigned to the SprayShieldâ„¢ or the control group in a 2:1 ratio. SETTING The study was conducted at the Clinic of Gynaecology and Obstetrics, at the University Hospital for Gynecology in Germany. PATIENTS Fifteen patients participated in this study; nine patients were assigned to the SprayShieldâ„¢ and six patients to the control group. INTERVENTIONS During first operation (FLL) in the SprayShieldâ„¢ 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 8-12 weeks after myomectomy to evaluate adhesion formation. MAIN OUTCOME MEASURES Main outcome measures were incidence, severity, and extent of uterine adhesions. RESULTS No significant differences were found between the two study groups. CONCLUSIONS SprayShieldâ„¢ is easy to use. No serious adverse event related to SprayShieldâ„¢ was observed. Efficacy data are inconclusive regarding the performance of SprayShieldâ„¢. Further studies are needed to better understand this performance.