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

NCT00902148 | Completed Phase 4

• 1 other identifier: 20031124
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesions

Keywords

Surgery; Colectomy; Proctocolectomy; Adhesions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Control Group

NO INTERVENTION

Colorectal Surgery without use of SurgiWrapTM

Test Group

ACTIVE COMPARATOR

Colorectal Surgery with use of SurgiWrapTM film secured directly below the abdominal incision

Device: Polylactic Acid Sheet

Interventions

Polylactic Acid Sheet DEVICE

SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.

Also known as: SurgiWrapTM

Test Group

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MAST Biosurgery, AG: lead

Study Sites (1)

Akershus University Hospital

Lørenskog, Oslo County, N-0318, Norway

Location

MeSH Terms

Conditions

Tissue Adhesions

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arne Faerden, MD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 15, 2009
• Study Start: December 1, 2003
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: May 15, 2009

Record last verified: 2009-05

Locations

NO (1)