Evaluation of Bioresorbable Sheet to Prevent Intra-Abdominal Adhesions in Colorectal Surgeries

Phase 4

Completed

• Conditions: Adhesions

• Registration Number: NCT00902148
• Lead Sponsor: MAST Biosurgery, AG

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2009-05
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-14
• Last Update Submitted: 2009-05-14
• Study First Posted: 2009-05-15
• Last Update Posted: 2009-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Akershus University Hospital; 🇳🇴 Lørenskog, Oslo, Norway