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):

October 10, 2008
October 13, 2008
August 20, 2013
September 28, 2015
September 28, 2015
December 2008
February 2012   (Final data collection date for primary outcome measure)
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay. [ Time Frame: 24 months ]
Occurrence of parastomal hernia [ Time Frame: 24 months ]
Complete list of historical versions of study NCT00771407 on Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
Parastomal Reinforcement With Strattice
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
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Parastomal Hernia
  • Device: Strattice Reconstructive Matrix
    Strattice will be placed as a fascial inlay to support stoma sites
  • Other: Standard ostomy creation
    Ostomy will be created as routinely performed
  • Active Comparator: Strattice fascial inlay
    Strattice will be placed as a fascial inlay to support the ostomy site
    Intervention: Device: Strattice Reconstructive Matrix
  • Standard ostomy construction
    Ostomy will be created in the standard fashion
    Intervention: Other: Standard ostomy creation

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2012
February 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Not Provided
Principal Investigator: James Fleshman, MD Washington University, St Louis MO
August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP