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

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ClinicalTrials.gov Identifier: NCT00902148
Recruitment Status : Completed
First Posted : May 15, 2009
Last Update Posted : May 15, 2009
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Adhesions Device: Polylactic Acid Sheet Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation of Intra-Abdominal Adhesions in Ileostomy Procedures When Using a Resorbable Polylactide Film (SurgiWrap) in Colorectal Surgeries
Study Start Date : December 2003
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
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




Primary Outcome Measures :
  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 [ Time Frame: 6 to 8 months ]


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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Arne E. Faerden, MD, Akershus University Hospital
ClinicalTrials.gov Identifier: NCT00902148     History of Changes
Other Study ID Numbers: 20031124
First Posted: May 15, 2009    Key Record Dates
Last Update Posted: May 15, 2009
Last Verified: May 2009

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

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes