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NCT03911700NARecruiting

Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

C. R. Bard

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

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 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 24 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

Interventions

DEVICE

Phasix™ Mesh

Interested in This Trial?

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Conditions

Open Midline Laparotomy

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