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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 19, 2014