Adhesions
Conditions
Keywords
Surgery, Colectomy, Proctocolectomy, Adhesions
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.
Interventions
DEVICEPolylactic Acid Sheet
SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.
Sponsors
MAST Biosurgery, AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 78 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 6 to 8 months |
Countries
Norway
Outcome results
None listed