search
Back to results

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

Primary Purpose

Adhesions

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Polylactic Acid Sheet
Sponsored by
MAST Biosurgery, AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adhesions focused on measuring Surgery, Colectomy, Proctocolectomy, Adhesions

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Akershus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Test Group

Arm Description

Colorectal Surgery without use of SurgiWrapTM

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 13, 2009
Last Updated
May 14, 2009
Sponsor
MAST Biosurgery, AG
search

1. Study Identification

Unique Protocol Identification Number
NCT00902148
Brief Title
Evaluation of Bioresorbable Sheet to Prevent Intra-Abdominal Adhesions in Colorectal Surgeries
Official Title
Evaluation of Intra-Abdominal Adhesions in Ileostomy Procedures When Using a Resorbable Polylactide Film (SurgiWrap) in Colorectal Surgeries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MAST Biosurgery, AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesions
Keywords
Surgery, Colectomy, Proctocolectomy, Adhesions

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Colorectal Surgery without use of SurgiWrapTM
Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
Colorectal Surgery with use of SurgiWrapTM film secured directly below the abdominal incision
Intervention Type
Device
Intervention Name(s)
Polylactic Acid Sheet
Other Intervention Name(s)
SurgiWrapTM
Intervention Description
SurgiWrapTM bioresorbable sheet will be secured directly below the abdominal incision.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arne Faerden, MD
Organizational Affiliation
University Hospital, Akershus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lørenskog
State/Province
Oslo
ZIP/Postal Code
N-0318
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs