Evaluation of Bioresorbable Sheet to Prevent Intra-Abdominal Adhesions in Colorectal Surgeries
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|ClinicalTrials.gov Identifier: NCT00902148|
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : May 15, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Adhesions||Device: Polylactic Acid Sheet||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Evaluation of Intra-Abdominal Adhesions in Ileostomy Procedures When Using a Resorbable Polylactide Film (SurgiWrap) in Colorectal Surgeries|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||March 2007|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902148
|Akershus University Hospital|
|Lørenskog, Oslo, Norway, N-0318|
|Principal Investigator:||Arne Faerden, MD||University Hospital, Akershus|