Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Start Date
12/12/2019
Completion Date
12/1/2031
Summary
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.
Detailed Description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Phasix™ Mesh
Conditions
Locations
Dignity Health
Phoenix, Arizona 85013
United States
Keck Medical Center of USC
Los Angeles, California 90033
United States
University of California San Francisco
San Francisco, California 94143
United States
Hartford Hospital
Hartford, Connecticut 06102
United States
St. Francis Hospital and Medical Center
Hartford, Connecticut 06105
United States
Emory University
Atlanta, Georgia 30322
United States
OSF Saint Francis Medical Center
Peoria, Illinois 61637
United States
Indiana University
Indianapolis, Indiana 46202
United States
University of Kentucky Research Foundation
Lexington, Kentucky 40508
United States
Tulane University School of Medicine
New Orleans, Louisiana 70112
United States
Boston Medical Center
Boston, Massachusetts 02118
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Minneapolis VA Health Care System
Minneapolis, Minnesota 55417
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
St. Luke's Hospital
Kansas City, Missouri 64111
United States
Cox Health
Springfield, Missouri 65807
United States
Washington University
St Louis, Missouri 63110
United States
Nebraska Medical Center
Omaha, Nebraska 68106
United States
Nebraska Methodist Hospital
Omaha, Nebraska 68114
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08901
United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York 10032
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Atrium Health
Charlotte, North Carolina 28203
United States
Duke University
Durham, North Carolina 27708
United States
New Hanover Regional Medical Center
Wilmington, North Carolina 28401
United States
The Ohio State University
Columbus, Ohio 43210
United States
Oregon Health & Science University
Portland, Oregon 97239
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Baptist Clinical Research Institute
Memphis, Tennessee 38163
United States
Vanderbilt University
Nashville, Tennessee 37232
United States
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia 25304
United States
Krankenhaus der Barmherzigen Brüder Graz
Graz, 08020
Austria
Universitair Ziekenhuis Gent
Ghent, 09000
Belgium
CHU de Dijon Bourgogne
Dijon, 21079
France
Centre Hospitalier Universitaire de Lille
Lille, 59000
France
Centre Hospitalier Universitaire de Lille
Lille, 59000
France
Hôpital Paris St Joseph
Paris, 75014
France
Hôpital Lyon Sud
Pierre-Bénite, 69495
France
CHU Reims
Reims, 51092
France
Hopitaux Universitaires de Strasbourg
Strasbourg, 67000
France
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
Berlin, 13353
Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery
Berlin, 13353
Germany
Asklepios Klinik Barmbek
Hamburg, 22307
Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120
Germany
Bundeswehrzentralkrankenhaus Koblenz
Koblenz, 56072
Germany