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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | No Intervention | Colorectal Surgery without use of SurgiWrapTM | |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polylactic Acid Sheet | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the efficacy of SurgiWrapTM in the prevention/reduction of Grade 2 or higher soft tissue attachments under the abdominal incision made during colorectal surgery | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical and radiographic evidence of bowel obstruction | 5 to 30 days | |
| The incidence and extent of soft tissue attachments under the abdominal incision and on the pelvic floor after colorectal surgery | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander M Milstein, MD | Cytori Therapeutics | Study Director |
| Robert Beard, MD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California Norris Cancer Hospital | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D000267 | Tissue Adhesions |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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