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Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
This trial is being conducted to evaluate the efficacy of Phasix™ Mesh implantation at the time of midline fascial closure compared to primary suture closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery.
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Dignity Health
Phoenix, Arizona, United States
Keck Medical Center of USC
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Hartford Hospital
Hartford, Connecticut, United States
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States
Emory University
Atlanta, Georgia, United States
OSF Saint Francis Medical Center
Peoria, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
University of Kentucky Research Foundation
Lexington, Kentucky, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
Start Date
December 12, 2019
Primary Completion Date
December 1, 2029
Completion Date
December 1, 2031
Last Updated
February 25, 2026
477
ESTIMATED participants
Phasix™ Mesh
DEVICE
Lead Sponsor
C. R. Bard
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.
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