Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
NCT ID: NCT03911700
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
477 participants
INTERVENTIONAL
2019-12-12
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Phasix™ Mesh
Prophylactic onlay placement of mesh.
Phasix™ Mesh
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
Primary Suture Closure
Standard Fascial closure.
No interventions assigned to this group
Interventions
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Phasix™ Mesh
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
Eligibility Criteria
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Inclusion Criteria
2. Elective, open midline laparotomy ≥ 5 cm
3. Willing and able to provide written informed consent
4. Hernia risk equal to moderate or greater
Exclusion Criteria
2. Emergent surgery
3. Creation of skin flaps is preplanned
4. Preplanned 2nd surgery
5. Active skin pathology
6. Life expectancy less than 36 months
7. Pregnant or planning to become pregnant
8. Receiving a medication/medical condition that may adversely affect wound healing
9. ASA Class \> IV
10. Enrolled in another clinical trial
11. Site personnel directly involved with this trial
12. Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
13. Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
14. Two separate incisions are created
15. Prior onlay mesh
16. Surgeon is unable to fully close the fascia
17. The surgery requires more than a single piece of mesh
18. Contraindication to placement of mesh
19. CDC Class IV/Active Infection
20. Breastfeeding
18 Years
ALL
No
Sponsors
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C. R. Bard
INDUSTRY
Responsible Party
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Principal Investigators
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William Hope, MD
Role: PRINCIPAL_INVESTIGATOR
New Hanover Regional Medical Center
Locations
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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
University of Michigan
Ann Arbor, Michigan, United States
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
St. Luke's Hospital
Kansas City, Missouri, United States
Cox Health
Springfield, Missouri, United States
Washington University
St Louis, Missouri, United States
Nebraska Medical Center
Omaha, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
New York Presbyterian Hospital-Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Atrium Health
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
The Ohio State University
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Vanderbilt University
Nashville, Tennessee, United States
CAMC Health Education and Research Institute, Inc.
Charleston, West Virginia, United States
Krankenhaus der Barmherzigen Brüder Graz
Graz, , Austria
Universitair Ziekenhuis Gent
Ghent, , Belgium
CHU de Dijon Bourgogne
Dijon, , France
Centre Hospitalier Universitaire de Lille
Lille, , France
Centre Hospitalier Universitaire de Lille
Lille, , France
Hôpital Paris St Joseph
Paris, , France
Hôpital Lyon Sud
Pierre-Bénite, , France
CHU Reims
Reims, , France
Hopitaux Universitaires de Strasbourg
Strasbourg, , France
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology
Berlin, , Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery
Berlin, , Germany
Asklepios Klinik Barmbek
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Bundeswehrzentralkrankenhaus Koblenz
Koblenz, , Germany
Countries
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Central Contacts
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Facility Contacts
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Mitzy Vazquezgamez
Role: primary
Angelina Phan
Role: primary
Sydney Cloyd
Role: primary
Delainna Bartholomew
Role: primary
Kathryn Vera
Role: primary
Anna Rois
Role: primary
Christian Misdary
Role: primary
Samanthan Straka
Role: primary
Kayla Diaz
Role: primary
Carolina Reyes
Role: primary
Kimberly Fields
Role: primary
Gabriele Moitzi
Role: primary
Betsy van Loo
Role: primary
Aurélie Degot
Role: primary
Bertin Elion Dzon
Role: primary
Katia Lecolle
Role: primary
Camille Calvez
Role: primary
Claire-Angeline Goutard
Role: primary
Cédric Castex
Role: primary
Samantha Becker
Role: primary
Sabine Drießelmann
Role: primary
Oriel Mangadze
Role: primary
Ute Vahid Dastgerdi
Role: primary
Other Identifiers
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DVL-HE-018
Identifier Type: -
Identifier Source: org_study_id