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Sponsored by: |
Cytori Therapeutics |
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Information provided by: | Cytori Therapeutics |
ClinicalTrials.gov Identifier: | NCT00531739 |
The purpose of this study is to determine if the use of SurgiWrapTM: (1) prevents/lowers the incidence of Grade 2 or higher soft tissue attachments under the incision made during abdominal surgery, (2) reduces post-operative bowel obstruction.
Condition | Intervention | Phase |
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Adhesions Colectomy |
Other: Polylactic Acid Sheet |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 4 Evaluation of SurgiWrapTM to Minimize Soft Tissue Attachment & Reduce the Incidence of Early Post-Operative Bowel Obstruction in Colorectal Surgery |
Estimated Enrollment: | 60 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | February 2009 |
Arms | Assigned Interventions |
---|---|
A: No Intervention
Colorectal Surgery without use of SurgiWrapTM
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B: Active Comparator
Colorectal Surgery with use of SurgiWrapTM film secured in two study areas: the posterior pelvic rim and directly below the abdominal incision
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Other: Polylactic Acid Sheet
SurgiWrapTM film will be secured in two study areas: directly below the abdominal incision and on the posterior pelvic rim. The film will not be wrapped directly around an anastomosis.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Martin | 858-875-5212 | mmartin@cytoritx.com |
United States, California | |
University of Southern California Norris Cancer Hospital | Recruiting |
Los Angeles, California, United States, 90033 | |
Principal Investigator: Robert Beard, MD |
Study Director: | Alexander M Milstein, MD | Cytori Therapeutics |
Principal Investigator: | Robert Beard, MD | University of Southern California - Norris Cancer Hospital |
Study ID Numbers: | SURGIWRAP(TM) |
Study First Received: | September 18, 2007 |
Last Updated: | September 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00531739 |
Health Authority: | United States: Institutional Review Board |
Surgery Colectomy Proctocolectomy Adhesions |
Intestinal Obstruction Digestive System Diseases Gastrointestinal Diseases Adhesions Intestinal Diseases |
Pathologic Processes |