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A Multicenter, Prospective, Randomized, Controlled, Single-Blinded Study of Strattice Reconstructive Tissue Matrix vs Proceed
Support of a ventral hernia repair with a prosthetic mesh has been demonstrated to result in a diminished rate of hernia recurrence. The patient with co-morbidities undergoing hernia repair is at increased risk of wound related complications, which may be exacerbated by the choice of prosthetic mesh, and which are known to influence the ultimate rate of hernia recurrence. It is hypothesized that patients receiving a mesh of biologic origin may experience fewer wound related complications and hence at least an equal rate of hernia recurrence, compared to those receiving a synthetic mesh.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Louisiana Status University Health Sciences Center
New Orleans, Louisiana, United States
Tulane University
New Orleans, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
University of Maryland
Baltimore, Maryland, United States
Boston Veterans Administration Healthcare System
West Roxbury, Massachusetts, United States
Hurley Medical Center
Flint, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Truman Medical Center
Kansas City, Missouri, United States
Long Island Jewish - North Shore
Lake Success, New York, United States
University Hospital - Case Western
Cleveland, Ohio, United States
Start Date
August 1, 2009
Primary Completion Date
May 1, 2010
Completion Date
May 1, 2010
Last Updated
November 20, 2013
23
ACTUAL participants
Strattice Reconstructive Tissue Matrix (Hernia Repair)
DEVICE
Proceed Surgical Mesh (Hernia repair)
DEVICE
Lead Sponsor
LifeCell
NCT07451483
NCT07422584
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05142618