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

Adhesions Clinical Trial

Official title:

Evaluation of Intra-Abdominal Adhesions in Ileostomy Procedures When Using a Resorbable Polylactide Film (SurgiWrap) in Colorectal Surgeries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902148
• Other study ID #: 20031124
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2009
• Last updated: May 14, 2009
• Start date: December 2003
• Est. completion date: March 2007

Study information

• Verified date: May 2009
• Source: MAST Biosurgery, AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 78 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adhesions
• Tissue Adhesions

Intervention

Device:
• Polylactic Acid Sheet
SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
MAST Biosurgery, AG

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No