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Parastomal Reinforcement With Strattice (PriSm)

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ClinicalTrials.gov Identifier: NCT00771407
Recruitment Status : Completed
First Posted : October 13, 2008
Results First Posted : September 28, 2015
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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
Primary Completion Date : February 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

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

Arms and Interventions

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


Outcome Measures

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 ]

Eligibility Criteria

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