Status:
COMPLETED
Parastomal Reinforcement With Strattice
Lead Sponsor:
LifeCell
Conditions:
Parastomal Hernia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- adults
- need for permanent ileostomy or colostomy
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00771407
Start Date
December 1 2008
End Date
July 1 2012
Last Update
September 28 2015
Active Locations (23)
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1
University of South Alabama
Mobile, Alabama, United States
2
Office of Dr Phillip Fleshner
Los Angeles, California, United States
3
University of California at Irvine
Orange, California, United States
4
Stanford University Medical Center
Stanford, California, United States