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

This study has been completed.
Sponsor:
Information provided by:
MAST Biosurgery, AG
ClinicalTrials.gov Identifier:
NCT00902148
First received: May 13, 2009
Last updated: May 14, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Adhesions
Device: Polylactic Acid Sheet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Evaluation of Intra-Abdominal Adhesions in Ileostomy Procedures When Using a Resorbable Polylactide Film (SurgiWrap) in Colorectal Surgeries

Resource links provided by NLM:


Further study details as provided by MAST Biosurgery, AG:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 to 8 months ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: December 2003
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Colorectal Surgery without use of SurgiWrapTM
Active Comparator: Test Group
Colorectal Surgery with use of SurgiWrapTM film secured directly below the abdominal incision
Device: Polylactic Acid Sheet
SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.
Other Name: SurgiWrapTM

  Eligibility

Ages Eligible for Study:   18 Years to 78 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902148

Locations
Norway
Akershus University Hospital
Lørenskog, Oslo, Norway, N-0318
Sponsors and Collaborators
MAST Biosurgery, AG
Investigators
Principal Investigator: Arne Faerden, MD University Hospital, Akershus
  More Information

No publications provided

Responsible Party: Arne E. Faerden, MD, Akershus University Hospital
ClinicalTrials.gov Identifier: NCT00902148     History of Changes
Other Study ID Numbers: 20031124
Study First Received: May 13, 2009
Last Updated: May 14, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency

Keywords provided by MAST Biosurgery, AG:
Surgery
Colectomy
Proctocolectomy
Adhesions

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014