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

MAST Biosurgery, AG19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Adhesions

Interventions

Polylactic Acid SheetDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 78 Years

Medical Language ↔ Plain English

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

Locations (1)

Akershus University Hospital

Lørenskog, Oslo County, Norway

Outcomes

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

Data from ClinicalTrials.gov

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