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

Phase 4

Completed

• Conditions: Adhesions
• Interventions: Device: Polylactic Acid Sheet

• 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

Arm && Interventions

Group	Intervention	Description
Test Group	Polylactic Acid Sheet	Colorectal Surgery with use of SurgiWrapTM film secured directly below the abdominal incision

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