Evaluation of Bioresorbable Sheet to Prevent Intra-Abdominal Adhesions in Colorectal Surgeries
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Official Title:||Evaluation of Intra-Abdominal Adhesions in Ileostomy Procedures When Using a Resorbable Polylactide Film (SurgiWrap) in Colorectal Surgeries|
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2003|
|Study Completion Date:||March 2007|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
No Intervention: Control Group
Colorectal Surgery without use of SurgiWrapTM
Active Comparator: Test Group
Colorectal Surgery with use of SurgiWrapTM film secured directly below the abdominal incision
Device: Polylactic Acid Sheet
SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.
Other Name: SurgiWrapTM