Safety and Efficacy Study of a Hydrogel, Applied Following Removal of Myomas During Gynecologic Surgery, Administered for the Prevention/Reduction of Postoperative Adhesion Formation

Study Overview
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Brief Summary
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The purpose of this study was to determine whether the adhesion prevention gel was safe to use, and was effective for the prevention/reduction of adhesion formation that typically occurs following gynecological surgery to remove myomas

Detailed Description
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Postoperative 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 Adhibit™ Adhesion Prevention Gel versus the standard of care for the reduction of postoperative adhesions in subjects undergoing myomectomy via laparotomy or laparoscopy. Subjects were scheduled to return within 6-8 weeks after the initial surgical procedure. At that time, a second-look laparoscopy was performed for postoperative adhesion assessment. Adhesions were graded using a modified American Fertility Society (mAFS) scoring method.

Official Title
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A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery

Conditions
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Myoma

Intervention / Treatment
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* Other: Adhibit Adhesion Prevention Gel
* Other: Standard of Care Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Preoperatively, subjects must have had: Been scheduled for myomectomy via laparotomy or laparoscopy. Agreed to a second-look laparoscopic procedure to assess and lyse any adhesions formed at 6 to 8 weeks following myomectomy. Been >=18 years of age. Provided voluntary written informed consent. Been willing to comply with all aspects of the treatment and evaluation schedule. Intra-operatively, subjects must have had: Had at least one 2 cm incision length on posterior uterine surface, which may include the fundal surface. Exclusion Criteria: Preoperatively, subjects must not have had: Been pregnant. Had a pelvic malignancy. Had acute pelvic inflammatory disease. Had an immune compromised condition. Been a participant in another clinical research study which the investigator believed could interfere with the purpose of this study. Been given corticosteroids intra-operatively or during the course of the postoperative study follow up. Intra-operatively, subjects must not have had: Had a pelvic malignancy. Had a pelvic or abdominal infection. Had acute pelvic inflammatory disease. Received any adhesion prevention adjuvants or barriers, or peritoneal instillates containing corticosteroids, NSAIDs, or Dextran.

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Adhesion Prevention Gel Arm | Other: Adhibit Adhesion Prevention Gel<br>* A resorbable hydrogel, which adheres to itself and the tissues it contacts, is approved for use in sealing vascular reconstructions. The hydrogel is formed when two synthetic derivatized polyethylene glycol (PEG) polymers are mixed together and applied to tissue. Using a gas-assisted delivery device, the hydrogel is sprayed over all myomectomy suture lines and all surgically treated areas during the myomectomy surgery. The hydrogel is totally resorbed within 30 days post-application.<br>* Other names: CoSeal Surgical Sealant; CoSeal Adhesion Prevention Gel;|
| Other: 2<br>Standard of Care Comparator Arm (standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure) | Other: Standard of Care Comparator<br>* standard of care for post-operative adhesion prevention included irrigation of tissues and lavage of all fluids with Ringers Lactate solution following surgery and 300 to 500mL of solultion left in the pelvic cavity immediately prior to wound closure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified American Fertility Society (mAFS) score at the posterior uterus |  | 6-8 weeks following primary myomectomy surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adhesion extent and tenacity scores at the posterior uterus |  | 6-8 weeks following primary myomectomy surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adhesions, gynecologic surgery, laparoscopy, laparotomy, polyethylene glycol, hydrogel, Adhesions following gynecologic surgery to remove myomas