NCT02166554

The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions

The Efficacy and Safety of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Adhesions After Laparoscopic Gynecological Surgery: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: BioRegen Biomedical (CHangzhou) Co., Ltd · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery

Detailed description

Postsurgical adhesions are a common medical complication of gynecologic and pelvic surgeries, and are frequently associated with chronic or recurrent pelvic pain, intestinal obstruction and infertility. This randomized, controlled, multicenter, clinical study was designed to evaluate the safety and performance of the new crosslinked hyaluronan hydrogel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing laparoscopic surgeries. Subjects were scheduled to return at 9 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postsurgical adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring system.

Conditions

• Myomas
• Ovary Cysts
• Endometriotic Cysts
• Adhesions

Interventions

Type	Name	Description
OTHER	Saline	On the day of initial surgery
DEVICE	Cross-linked Hyaluronan Hydrogel	On the day of the initial surgery

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2014-06-18
• Last updated: 2014-06-18

Locations

7 sites across 1 country: China