Evaluation of Intra-Abdominal Adhesions in Ileostomy Procedures When Using a Resorbable Polylactide Film (SurgiWrap) in Colorectal Surgeries
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Adhesions
- Sponsor
- MAST Biosurgery, AG
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Assess the extent and severity of new formed adhesions having its source in the target region where the SurgiWrap film initially was placed: between the midline incision/scar and the omentum, and between the midline incision/scar and the small bowel
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
Study to investigate and determine the difference between the extent and severity of intra-abdominal adhesions in patients where SurgiWrap film was placed compared to patients with no adhesion barrier inserted.
Hypothesis: Due to the preclinical safety data and clinical case reports in various indications it is anticipated that the surgical sites where the resorbable anti-adhesion barrier SurgiWrap was placed, there will be a reduction of adhesions compared to the control group with no treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with rectal cancer, ulcerative colitis or other pathologies requiring a second surgery for ileostomy closure.
- •Age between 18 and 78 years.
- •Patient or his/her legal representative has read and signed the approved Informed Consent form before randomization.
Exclusion Criteria
- •Previous abdominal operation through a midline approach
- •Use of hernia mesh
- •Use of any antiadhesive irrigants or irrigants containing corticosteroids, heparin, salicylates, nonsteroidal anti-inflammatory drugs.
- •Pregnancy
Outcomes
Primary Outcomes
Assess the extent and severity of new formed adhesions having its source in the target region where the SurgiWrap film initially was placed: between the midline incision/scar and the omentum, and between the midline incision/scar and the small bowel
Time Frame: 6 to 8 months