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

BioRegen

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ovary Cysts; Adhesions; Myomas; Endometriotic Cysts

Treatments: Other: Saline; Device: Cross-linked Hyaluronan Hydrogel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02166554

FNL-2011-05

Details and patient eligibility

About

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

Full 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.

Enrollment: 216 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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216 participants in 2 patient groups, including a placebo group

Control Arm

Placebo Comparator group

Description:

Standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery

Treatment:

Other: Saline

Cross-linked Hyaluronan Hydrogel Arm

Experimental group

Description:

HyaRegen

Treatment:

Device: Cross-linked Hyaluronan Hydrogel