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

Phase 1

Completed

• Conditions: Myomas; Ovary Cysts; Endometriotic Cysts; Adhesions
• Interventions: Other: Saline; Device: Cross-linked Hyaluronan Hydrogel

• Registration Number: NCT02166554
• Lead Sponsor: BioRegen Biomedical (CHangzhou) Co., Ltd

Brief 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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2014-06
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-16
• Last Update Submitted: 2014-06-16
• Study First Posted: 2014-06-18
• Last Update Posted: 2014-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 216

Inclusion Criteria

• Female.
• Aged 18-45 years.
• Been scheduled for removal of myomas, ovary cysts, endometriotic cysts or adhesions.
• Been willing to comply with all aspects of the treatment and evaluation schedule.
• Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 9 weeks following the primary surgery.
• Provided voluntary written informed consent.

Exclusion Criteria

• Acute or severe infection.
• Autoimmune diseases such as diabetes etc.
• Abnormal liver/renal and cardiovascular function
• Abnormal blood coagulation
• Medical histories of peripheral vascular disease, alcohol or drug abuse, and mental illness.
• Known or suspected intolerance or hypersensitivity to hyaluronan or its derivatives.
• Concurrent use of systemic antiinflammatory drugs.
• Clinical evidence of cancer.
• Use of anticoagulant, fibrin glue, other thrombogenic agents, or any other anti-adhesion agent during the procedure.
• Concurrent peritoneal grafting or tubal implantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Saline	Standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery
Cross-linked Hyaluronan Hydrogel Arm	Cross-linked Hyaluronan Hydrogel	HyaRegen

Primary Outcome Measures

Name	Time	Method
The adhesion incidence under moderate/severe category	9 weeks following primary laparoscopic gynecological surgery	The patient percentage with modified American Fertility Society (mAFS) score (ovaries and tubes) more than 4 points.

Secondary Outcome Measures

Name	Time	Method
modified American Fertility Society (mAFS) score	9 weeks following primary laparoscopic gynecological surgery	modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity)
Adhesion extent	9 weeks following primary laparoscopic gynecological surgery	Adhesion extent (throughout abdominopelvic cavity)
Adhesion severity	9 weeks following primary laparoscopic gynecological surgery	Adhesion severity (throughout abdominopelvic cavity)
The adhesion incidence under moderate/severe category	9 weeks following primary laparoscopic gynecological surgery	The patient percentage with modified American Fertility Society (mAFS) score (throughout abdominopelvic cavity) more than 4 points.
Adverse events	Up to 9 weeks	Safety evaluation was based on clinical laboratory tests, the type and severity of adverse events recorded throughout the study, etc.

Trial Locations

Locations (7)

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, Beijing, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Hospital; 🇨🇳 Beijing, Beijing, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

The Third Xiangya Hospital; 🇨🇳 Changsha, Hunan, China

Qilu Hospital; 🇨🇳 Jinan, Shandong, China