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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

  Show 23 Study Locations
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 23, 2013