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Sponsored by: |
Angiotech Pharmaceuticals |
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Information provided by: | Angiotech Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00562471 |
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
Condition | Intervention | Phase |
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Myoma |
Other: Adhibit Adhesion Prevention Gel Other: Standard of Care Comparator |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Controlled Randomized Multicenter Study to Assess the Safety and Performance of Adhibit™ Adhesion Prevention Gel in Myomectomy Surgery |
Enrollment: | 76 |
Study Start Date: | July 2003 |
Study Completion Date: | January 2005 |
Arms | Assigned Interventions |
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1: Experimental
Adhesion Prevention Gel Arm
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Other: Adhibit Adhesion Prevention Gel
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.
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2
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)
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Other: Standard of Care Comparator
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
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Preoperatively, subjects must have had:
Intra-operatively, subjects must have had:
Exclusion Criteria:
Preoperatively, subjects must not have had:
Intra-operatively, subjects must not have had:
Canada, Ontario | |
St. Joseph's Health Centre | |
Toronto, Ontario, Canada, M6R 3B2 | |
Germany | |
Univ. Clinics of Schleswig-Holstein | |
Kiel, Germany, 24105 | |
Bethesda Krankenhaus Wupperta | |
Wuppertal, Germany, 42109 | |
Klinik für Minimal Invasive Chirurgie | |
Berlin, Germany, 14129 | |
Universitätsklinikum Giessen | |
Giessen, Germany, D-35385 | |
Netherlands Antilles | |
St. Elizabeth Hospital | |
Curaçao, Netherlands Antilles |
Principal Investigator: | Liselotte METTLE, MD, PhD | Univ. Clinics of Schleswig-Holstein |
Study ID Numbers: | ADH-02-1, ADH-02-1.1, ADH-02-1.2, ADH-02-1.3 |
Study First Received: | November 20, 2007 |
Last Updated: | November 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00562471 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Canada: Health Canada |
adhesions gynecologic surgery laparoscopy laparotomy |
polyethylene glycol hydrogel Adhesions following gynecologic surgery to remove myomas |
Neoplasms, Connective and Soft Tissue Adhesions Myoma |
Neoplasms, Muscle Tissue Neoplasms Neoplasms by Histologic Type Pathologic Processes |