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

Study Overview
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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

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.

Official Title
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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

Conditions
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Myomas, Ovary Cysts, Endometriotic Cysts, Adhesions

Intervention / Treatment
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* Other: Saline
* Device: Cross-linked Hyaluronan Hydrogel


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Arm<br>Standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with saline placebo following surgery | Other: Saline<br>* On the day of initial surgery<br>|
| Experimental: Cross-linked Hyaluronan Hydrogel Arm<br>HyaRegen | Device: Cross-linked Hyaluronan Hydrogel<br>* On the day of the initial surgery<br>* Other names: Self Cross-linked Hyaluronan Gel;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adhesions, Hyaluronan, Gynaecological surgery, Clinical outcomes