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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adhesions Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Tissue Adhesions

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Akershus University Hospital

Lørenskog, Oslo, N-0318, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polylactic Acid Sheet

Device

SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.

Other names: SurgiWrapTM

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

MAST Biosurgery, AG

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Primary completion: 2007
Study completion: 2007
First posted: May 15, 2009
Registry last updated: May 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed