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RECRUITING
NCT03911700
NA

Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

Sponsor: C. R. Bard

View on ClinicalTrials.gov

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.

Official title: Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

477

Start Date

2019-12-12

Completion Date

2031-12

Last Updated

2026-02-25

Healthy Volunteers

No

Interventions

DEVICE

Phasix™ Mesh

Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).

Locations (44)

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