SurgiWrapTM to Reduce Soft Tissue Attachment & Incidence Early Post-Operative Bowel Obstruction in Colorectal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Phase 4 Evaluation of SurgiWrapTM to Minimize Soft Tissue Attachment & Reduce the Incidence of Early Post-Operative Bowel Obstruction in Colorectal Surgery

Conditions
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Adhesions, Colectomy

Intervention / Treatment
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* Other: Polylactic Acid Sheet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 years of age or older of either gender Patient has primary diagnosis requiring a two-stage colectomy or procto-colectomy Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before randomization. Patient must be able and willing to follow study procedures and instructions. Exclusion Criteria: Patient is participating in another clinical study which may influence adhesion formation. Patient has had barriers, solutions, or anti-adhesive therapy, other than SurgiWrapTM, as planned at randomization, placed in the abdomen at the time of the initial surgery Patient who, at the initial surgery, had administration of irrigants containing corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs, or dextran 70 Patient has one or more medical condition(s), including severe renal, hepatic, hematologic, neurologic, or immune disease that, in the opinion of the Investigator, would make the patient an inappropriate candidate for this study. Patient is taking chronic (i.e., > 2 weeks) therapeutic doses of medications known to affect healing such as nonsteroidal anti-inflammatory drugs. Prophylactic aspirin (less than or equal to 325 mg once daily) for cardiovascular indications will be permitted in patients. Patient has an infection in the intra-abdominal or pelvic area.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br>Colorectal Surgery without use of SurgiWrapTM | |
| Active Comparator: B<br>Colorectal Surgery with use of SurgiWrapTM film secured in two study areas: the posterior pelvic rim and directly below the abdominal incision | Other: Polylactic Acid Sheet<br>* 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.<br>* Other names: SurgiWrapTM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Colectomy, Proctocolectomy, Adhesions