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Parastomal Reinforcement With Strattice (PriSm)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00771407
First Posted: October 13, 2008
Last Update Posted: September 28, 2015
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.
Information provided by (Responsible Party):
LifeCell
  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: 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

Resource links provided by NLM:


Further study details as provided by LifeCell:

Primary Outcome Measures:
  • 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:
  • Stoma Complications [ Time Frame: 30 days ]
  • Stoma Complications [ Time Frame: more than 1 month postoperatively ]
  • Stoma Quality of Life [ Time Frame: Serially over 24 months ]

Enrollment: 120
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

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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00771407


  Show 23 Study Locations
Sponsors and Collaborators
LifeCell
Investigators
Principal Investigator: James Fleshman, MD Washington University, St Louis MO
  More Information

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
First Submitted: October 10, 2008
First Posted: October 13, 2008
Results First Submitted: August 20, 2013
Results First Posted: September 28, 2015
Last Update Posted: September 28, 2015
Last Verified: August 2015

Keywords provided by LifeCell:
Ostomy creation
Parastomal hernia

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical