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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

October 10, 2008
February 12, 2013
December 2008
February 2012   (final data collection date for primary outcome measure)
Occurrence of parastomal hernia [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00771407 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Itani KM, Rosen M, Vargo D, Awad SS, Denoto G 3rd, Butler CE; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012 Sep;152(3):498-505. doi: 10.1016/j.surg.2012.04.008. Epub 2012 Jul 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00771407
LFC2008.01.01
No
LifeCell
LifeCell
Not Provided
Principal Investigator: James Fleshman, MD Washington University, St Louis MO
LifeCell
February 2013

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