Parastomal Reinforcement With Strattice (PriSm)

August 25, 2015 updated by: LifeCell

A Prospective, Multicenter, Randomized, Controlled, Third-party Blinded Study of Strattice Fascial Inlay for Parastomal Reinforcement in Patients Undergoing Surgery for Permanent Abdominal Wall Ostomies

The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States
        • University of South Alabama
    • California
      • Los Angeles, California, United States
        • Office of Dr Phillip Fleshner
      • Orange, California, United States
        • University of California at Irvine
      • Stanford, California, United States
        • Stanford University Medical Center
    • Florida
      • Tampa, Florida, United States
        • University of South Florida
      • Weston, Florida, United States
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, United States
        • University of Illinois
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States
        • Ochsner Clinic
      • New Orleans, Louisiana, United States
        • Louisiana State University
    • Maryland
      • Baltimore, Maryland, United States
        • University of Maryland/Baltimore VA
    • Michigan
      • Grand Rapids, Michigan, United States
        • Spectrum Health - Butterworth Hospital
    • Minnesota
      • St Paul, Minnesota, United States
        • Colon and Rectal Surgery Associates Ltd
    • Missouri
      • St Louis, Missouri, United States
        • Washington University School of Medicine - Barnes Jewish West
    • Nebraska
      • Omaha, Nebraska, United States
        • Colon & Rectal Surgery Inc
    • New York
      • Albany, New York, United States
        • Albany Medical College
      • New York City, New York, United States
        • Mt Sinai Medical Center
      • Stony Brook, New York, United States
        • Stony Brook University Medical Center
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States
        • The Christ Hospital Research
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Houston, Texas, United States
        • The Methodist Hospital
    • Vermont
      • Burlington, Vermont, United States
        • University of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adults
  • need for permanent ileostomy or colostomy

Exclusion Criteria:

  • history of hernia at new ostomy site
  • has previously implanted surgical mesh at site of planned ostomy
  • requires a temporary ostomy
  • has need for multiple ostomies
  • is receiving chronic immunosuppression therapy, has MELD score of > 17, has severe COPD, systemic infection, or known collagen disorder
  • is bedridden or otherwise non-ambulatory

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Strattice fascial inlay
Strattice will be placed as a fascial inlay to support the ostomy site
Device: Strattice Reconstructive Matrix
Strattice will be placed as a fascial inlay to support stoma sites
Other: Standard ostomy construction
Ostomy will be created in the standard fashion
Other: Standard ostomy creation
Ostomy will be created as routinely performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Stoma Complications
Time Frame: 30 days
30 days
Stoma Complications
Time Frame: more than 1 month postoperatively
more than 1 month postoperatively
Stoma Quality of Life
Time Frame: Serially over 24 months
Serially over 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeCell

Investigators

  • Principal Investigator: James Fleshman, MD, Washington University, St Louis MO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

October 10, 2008

First Submitted That Met QC Criteria

October 10, 2008

First Posted (Estimate)

October 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 28, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LFC2008.01.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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