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Parastomal Reinforcement With Strattice (PriSm)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LifeCell
ClinicalTrials.gov Identifier:
NCT00771407
First received: October 10, 2008
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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 Intervention Phase
Parastomal Hernia
 Device: Strattice Reconstructive Matrix
Other: Standard ostomy creation
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

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

Further study details as provided by LifeCell:

Primary Outcome Measures:
  • Occurrence of parastomal hernia [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Stoma complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Stoma complications [ Time Frame: more than 1 month postoperatively ] [ Designated as safety issue: Yes ]
  • Stoma Quality of Life [ Time Frame: Serially over 24 months ] [ Designated as safety issue: No ]

Enrollment: 113
Study Start Date: December 2008
Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771407

  Hide Study Locations
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
LifeCell
Investigators
Principal Investigator: James Fleshman, MD Washington University, St Louis MO
  More Information

No publications provided by LifeCell

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: LifeCell
ClinicalTrials.gov Identifier: NCT00771407     History of Changes
Other Study ID Numbers: LFC2008.01.01
Study First Received: October 10, 2008
Last Updated: February 12, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by LifeCell:
Ostomy creation
Parastomal hernia

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013