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

NCT ID: NCT00902148

Last Updated: 2009-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2007-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

Colorectal Surgery without use of SurgiWrapTM

Group Type: NO_INTERVENTION

No interventions assigned to this group

Test Group

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

Group Type: ACTIVE_COMPARATOR

Polylactic Acid Sheet

Intervention Type: DEVICE

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

Interventions

Polylactic Acid Sheet

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

Intervention Type: DEVICE

Other Intervention Names

SurgiWrapTM

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MAST Biosurgery, AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Akershus University Hospital

Principal Investigators

Arne Faerden, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

Akershus University Hospital

Lørenskog, Oslo County, Norway

Countries

Norway

Other Identifiers

20031124

Identifier Type: -

Identifier Source: org_study_id