Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

NCT03911700 | Recruiting DMC FDA Device

• 1 other identifier: DVL-HE-018
• Study Type: interventional
• Target: 477
• Locations: 5 countries
• Sites: 44

Brief 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.

Conditions

Open Midline Laparotomy

Outcome Measures

Primary Outcomes (1)

• Rate of Incisional Hernia

  The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group)

  24-Months

Secondary Outcomes (7)

• Rate of Incisional Hernia

  60-Months

• Rate of Device-related Adverse Events (AEs)

  60-Months

• Length of surgical procedure in minutes

  Study Day 0

• Length of time for wound closure in minutes

  Study Day 0

• Length of hospital stay in days

  Through hospital stay, typically 3 days

Study Arms (2)

Phasix™ Mesh

EXPERIMENTAL

Prophylactic onlay placement of mesh.

Device: Phasix™ Mesh

Primary Suture Closure

NO INTERVENTION

Standard Fascial closure.

Interventions

Phasix™ Mesh DEVICE

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

Phasix™ Mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous hernia repair
• Emergent surgery
• Creation of skin flaps is preplanned
• Preplanned 2nd surgery
• Active skin pathology
• Life expectancy less than 24 months
• Pregnant or planning to become pregnant
• Receiving a medication/medical condition that may adversely affect wound healing
• ASA Class \> IV
• Enrolled in another clinical trial
• Site personnel directly involved with this trial
• Any condition that would preclude the use of the device or the subject form completing the follow-up requirements
• Known or suspected allergy to tetracycline hydrochloride or kanamycin sulfate
• Two separate incisions are created
• Prior onlay mesh

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (44)

Dignity Health

Phoenix, Arizona, 85013, United States

RECRUITING

Keck Medical Center of USC

Los Angeles, California, 90033, United States

WITHDRAWN

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06102, United States

ACTIVE NOT RECRUITING

St. Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

WITHDRAWN

Emory University

Atlanta, Georgia, 30322, United States

TERMINATED

OSF Saint Francis Medical Center

Peoria, Illinois, 61637, United States

ACTIVE NOT RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

ACTIVE NOT RECRUITING

University of Kentucky Research Foundation

Lexington, Kentucky, 40508, United States

RECRUITING

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

RECRUITING

University of Michigan

Ann Arbor, Michigan, 48109, United States

WITHDRAWN

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

WITHDRAWN

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

WITHDRAWN

Cox Health

Springfield, Missouri, 65807, United States

WITHDRAWN

Washington University

St Louis, Missouri, 63110, United States

RECRUITING

Nebraska Medical Center

Omaha, Nebraska, 68106, United States

WITHDRAWN

Nebraska Methodist Hospital

Omaha, Nebraska, 68114, United States

WITHDRAWN

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

New York Presbyterian Hospital-Columbia University Medical Center

New York, New York, 10032, United States

ACTIVE NOT RECRUITING

Montefiore Medical Center

The Bronx, New York, 10467, United States

ACTIVE NOT RECRUITING

Atrium Health

Charlotte, North Carolina, 28203, United States

ACTIVE NOT RECRUITING

Duke University

Durham, North Carolina, 27708, United States

WITHDRAWN

New Hanover Regional Medical Center

Wilmington, North Carolina, 28401, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Oregon Health & Science University

Portland, Oregon, 97239, United States

WITHDRAWN

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Baptist Clinical Research Institute

Memphis, Tennessee, 38163, United States

ACTIVE NOT RECRUITING

Vanderbilt University

Nashville, Tennessee, 37232, United States

RECRUITING

CAMC Health Education and Research Institute, Inc.

Charleston, West Virginia, 25304, United States

ACTIVE NOT RECRUITING

Krankenhaus der Barmherzigen Brüder Graz

Graz, 08020, Austria

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 09000, Belgium

RECRUITING

CHU de Dijon Bourgogne

Dijon, 21079, France

RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

RECRUITING

Hôpital Paris St Joseph

Paris, 75014, France

RECRUITING

Hôpital Lyon Sud

Pierre-Bénite, 69495, France

RECRUITING

CHU Reims

Reims, 51092, France

RECRUITING

Hopitaux Universitaires de Strasbourg

Strasbourg, 67000, France

RECRUITING

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology

Berlin, 13353, Germany

WITHDRAWN

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Surgery

Berlin, 13353, Germany

WITHDRAWN

Asklepios Klinik Barmbek

Hamburg, 22307, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

RECRUITING

Bundeswehrzentralkrankenhaus Koblenz

Koblenz, 56072, Germany

RECRUITING

Study Officials

• William Hope, MD

  New Hanover Regional Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Resendes, MBA

CONTACT

401-209-7141; amanda.resendes@bd.com

Jaime Ritter, MPH

CONTACT

404-327-1221; jaime.ritter@bd.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 11, 2019
• Study Start: December 12, 2019
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2031
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (5); BE (1); FR (7); US (30)