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

MAST Biosurgery

Status and phase: Completed; Phase 4

Conditions: Adhesions

Treatments: Device: Polylactic Acid Sheet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902148

20031124

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

19 participants in 2 patient groups

Control Group

No Intervention group

Description:

Colorectal Surgery without use of SurgiWrapTM

Test Group

Active Comparator group

Description:

Colorectal Surgery with use of SurgiWrapTM film secured directly below the abdominal incision

Treatment:

Device: Polylactic Acid Sheet