Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

Last updated: May 2, 2025
Sponsor: C. R. Bard
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Phasix™ Mesh

Clinical Study ID

NCT03911700
DVL-HE-018
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Must be ≥ 18 years of age

  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

Exclusion Criteria:

  1. Previous hernia repair

  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 formcompleting 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

Study Design

Total Participants: 477
Treatment Group(s): 1
Primary Treatment: Phasix™ Mesh
Phase:
Study Start date:
December 12, 2019
Estimated Completion Date:
December 31, 2031

Study Description

Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.

Connect with a study center

  • Krankenhaus der Barmherzigen Brüder Graz

    Graz, 08020
    Austria

    Active - Recruiting

  • Universitair Ziekenhuis Gent

    Gent, 09000
    Belgium

    Active - Recruiting

  • CHU de Dijon Bourgogne

    Dijon, 21079
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Lille

    Lille, 59000
    France

    Active - Recruiting

  • Hôpital Paris St Joseph

    Paris, 75014
    France

    Active - Recruiting

  • Hôpital Lyon Sud

    Pierre-Benite, 69495
    France

    Active - Recruiting

  • CHU Reims

    Reims, 51092
    France

    Active - Recruiting

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67000
    France

    Active - Recruiting

  • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology

    Berlin, 13353
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery

    Berlin, 13353
    Germany

    Site Not Available

  • Asklepios Klinik Barmbek

    Hamburg, 22307
    Germany

    Active - Recruiting

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Bundeswehrzentralkrankenhaus Koblenz

    Koblenz, 56072
    Germany

    Active - Recruiting

  • Dignity Health

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • Keck Medical Center of USC

    Los Angeles, California 90033
    United States

    Site Not Available

  • University of California San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut 06105
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Terminated

  • OSF Saint Francis Medical Center

    Peoria, Illinois 61637
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • University of Kentucky Research Foundation

    Lexington, Kentucky 40508
    United States

    Active - Recruiting

  • Tulane University School of Medicine

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • Minneapolis VA Health Care System

    Minneapolis, Minnesota 55417
    United States

    Site Not Available

  • St. Luke's Hospital

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Cox Health

    Springfield, Missouri 65807
    United States

    Site Not Available

  • Nebraska Medical Center

    Omaha, Nebraska 68106
    United States

    Site Not Available

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10467
    United States

    Site Not Available

  • New York Presbyterian Hospital-Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Atrium Health

    Charlotte, North Carolina 28203
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27708
    United States

    Site Not Available

  • New Hanover Regional Medical Center

    Wilmington, North Carolina 28401
    United States

    Active - Recruiting

  • The Ohio State University

    Columbus, Ohio 43210
    United States

    Active - Recruiting

  • Oregon Health & Science University

    Portland, Oregon 97239
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Baptist Clinical Research Institute

    Memphis, Tennessee 38163
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • CAMC Health Education and Research Institute, Inc.

    Charleston, West Virginia 25304
    United States

    Site Not Available

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