Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
Status: Recruiting
Location: See all (43) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Must be ≥ 18 years of age
• Elective, open midline laparotomy ≥ 5 cm
• Willing and able to provide written informed consent
• Hernia risk equal to moderate or greater
Locations
United States
Arizona
Dignity Health
RECRUITING
Phoenix
California
Keck Medical Center of USC
WITHDRAWN
Los Angeles
University of California San Francisco
RECRUITING
San Francisco
Connecticut
Hartford Hospital
ACTIVE_NOT_RECRUITING
Hartford
St. Francis Hospital and Medical Center
WITHDRAWN
Hartford
Georgia
Emory University
TERMINATED
Atlanta
Illinois
OSF Saint Francis Medical Center
ACTIVE_NOT_RECRUITING
Peoria
Indiana
Indiana University
ACTIVE_NOT_RECRUITING
Indianapolis
Kentucky
University of Kentucky Research Foundation
RECRUITING
Lexington
Louisiana
Tulane University School of Medicine
RECRUITING
New Orleans
Michigan
University of Michigan
WITHDRAWN
Ann Arbor
Minnesota
Minneapolis VA Health Care System
WITHDRAWN
Minneapolis
University of Minnesota
RECRUITING
Minneapolis
Missouri
St. Luke's Hospital
WITHDRAWN
Kansas City
Cox Health
WITHDRAWN
Springfield
North Carolina
Atrium Health
ACTIVE_NOT_RECRUITING
Charlotte
Duke University
WITHDRAWN
Durham
New Hanover Regional Medical Center
RECRUITING
Wilmington
Nebraska
Nebraska Medical Center
WITHDRAWN
Omaha
Nebraska Methodist Hospital
WITHDRAWN
Omaha
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
New York Presbyterian Hospital-Columbia University Medical Center
ACTIVE_NOT_RECRUITING
New York
Montefiore Medical Center
ACTIVE_NOT_RECRUITING
The Bronx
Ohio
The Ohio State University
RECRUITING
Columbus
Oregon
Oregon Health & Science University
WITHDRAWN
Portland
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Baptist Clinical Research Institute
ACTIVE_NOT_RECRUITING
Memphis
Vanderbilt University
RECRUITING
Nashville
West Virginia
CAMC Health Education and Research Institute, Inc.
ACTIVE_NOT_RECRUITING
Charleston
Other Locations
Austria
Krankenhaus der Barmherzigen Brüder Graz
RECRUITING
Graz
Belgium
Universitair Ziekenhuis Gent
RECRUITING
Ghent
France
CHU de Dijon Bourgogne
RECRUITING
Dijon
Centre Hospitalier Universitaire de Lille
RECRUITING
Lille
Centre Hospitalier Universitaire de Lille
RECRUITING
Lille
Hôpital Paris St Joseph
RECRUITING
Paris
Hôpital Lyon Sud
RECRUITING
Pierre-bénite
CHU Reims
RECRUITING
Reims
Hopitaux Universitaires de Strasbourg
RECRUITING
Strasbourg
Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
WITHDRAWN
Berlin
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery
WITHDRAWN
Berlin
Asklepios Klinik Barmbek
RECRUITING
Hamburg
Universitätsklinikum Heidelberg
RECRUITING
Heidelberg
Bundeswehrzentralkrankenhaus Koblenz
RECRUITING
Koblenz
Contact Information
Primary
Amanda Resendes, MBA
amanda.resendes@bd.com
401-209-7141
Backup
Jaime Ritter, MPH
jaime.ritter@bd.com
404-327-1221
Time Frame
Start Date: 2019-12-12
Estimated Completion Date: 2031-12
Participants
Target number of participants: 477
Treatments
Experimental: Phasix™ Mesh
Prophylactic onlay placement of mesh.
No_intervention: Primary Suture Closure
Standard Fascial closure.
Authors
Related Therapeutic Areas
Sponsors
Leads: C. R. Bard