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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-04-30

Brief Summary

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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

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Detailed Description

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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

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Myomas Ovary Cysts Endometriotic Cysts Adhesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control Arm

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

On the day of initial surgery

Cross-linked Hyaluronan Hydrogel Arm

HyaRegen

Group Type EXPERIMENTAL

Cross-linked Hyaluronan Hydrogel

Intervention Type DEVICE

On the day of the initial surgery

Interventions

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Saline

On the day of initial surgery

Intervention Type OTHER

Cross-linked Hyaluronan Hydrogel

On the day of the initial surgery

Intervention Type DEVICE

Other Intervention Names

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HyaRegen Self Cross-linked Hyaluronan Gel

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No