Parastomal Reinforcement With Strattice
PriSm
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
1 other identifier
interventional
120
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2008
Longer than P75 for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2008
CompletedFirst Posted
Study publicly available on registry
October 13, 2008
CompletedStudy Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
September 28, 2015
CompletedSeptember 28, 2015
August 1, 2015
3.2 years
October 10, 2008
August 20, 2013
August 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.
24 months
Secondary Outcomes (3)
Stoma Complications
30 days
Stoma Complications
more than 1 month postoperatively
Stoma Quality of Life
Serially over 24 months
Study Arms (2)
Strattice fascial inlay
ACTIVE COMPARATORStrattice will be placed as a fascial inlay to support the ostomy site
Standard ostomy construction
OTHEROstomy will be created in the standard fashion
Interventions
Strattice will be placed as a fascial inlay to support stoma sites
Ostomy will be created as routinely performed
Eligibility Criteria
You may qualify if:
- adults
- need for permanent ileostomy or colostomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeCelllead
Study Sites (23)
University of South Alabama
Mobile, Alabama, United States
Office of Dr Phillip Fleshner
Los Angeles, California, United States
University of California at Irvine
Orange, California, United States
Stanford University Medical Center
Stanford, California, United States
University of South Florida
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
University of Illinois
Chicago, Illinois, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Louisiana State University
New Orleans, Louisiana, United States
Ochsner Clinic
New Orleans, Louisiana, United States
University of Maryland/Baltimore VA
Baltimore, Maryland, United States
Spectrum Health - Butterworth Hospital
Grand Rapids, Michigan, United States
Colon and Rectal Surgery Associates Ltd
Saint Paul, Minnesota, United States
Washington University School of Medicine - Barnes Jewish West
St Louis, Missouri, United States
Colon & Rectal Surgery Inc
Omaha, Nebraska, United States
Albany Medical College
Albany, New York, United States
Mt Sinai Medical Center
New York, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Christ Hospital Research
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Methodist Hospital
Houston, Texas, United States
University of Vermont
Burlington, Vermont, United States
Related Publications (2)
Fleshman JW, Beck DE, Hyman N, Wexner SD, Bauer J, George V; PRISM Study Group. A prospective, multicenter, randomized, controlled study of non-cross-linked porcine acellular dermal matrix fascial sublay for parastomal reinforcement in patients undergoing surgery for permanent abdominal wall ostomies. Dis Colon Rectum. 2014 May;57(5):623-31. doi: 10.1097/DCR.0000000000000106.
PMID: 24819103DERIVEDItani 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.
PMID: 22763262DERIVED
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- LifeCell Corporation
Study Officials
- PRINCIPAL INVESTIGATOR
James Fleshman, MD
Washington University, St Louis MO
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2008
First Posted
October 13, 2008
Study Start
December 1, 2008
Primary Completion
February 1, 2012
Study Completion
July 1, 2012
Last Updated
September 28, 2015
Results First Posted
September 28, 2015
Record last verified: 2015-08