Parastomal Reinforcement With Strattice (PriSm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771407
Recruitment Status : Completed
First Posted : October 13, 2008
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parastomal Hernia Device: Strattice Reconstructive Matrix Other: Standard ostomy creation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Official Title: 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
Study Start Date : December 2008
Actual Primary Completion Date : February 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia Ostomy
U.S. FDA Resources

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
Standard ostomy construction
Ostomy will be created in the standard fashion
Other: Standard ostomy creation
Ostomy will be created as routinely performed

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

Secondary Outcome Measures :
  1. Stoma Complications [ Time Frame: 30 days ]
  2. Stoma Complications [ Time Frame: more than 1 month postoperatively ]
  3. Stoma Quality of Life [ Time Frame: Serially over 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00771407

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