NCT00902148

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: MAST Biosurgery, AG · Industry
• Sex: All
• Age: 18 Years – 78 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Polylactic Acid Sheet	SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.

Timeline

• Start date: 2003-12-01
• Primary completion: 2007-03-01
• Completion: 2007-03-01
• First posted: 2009-05-15
• Last updated: 2009-05-15

Locations

1 site across 1 country: Norway