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Could a simple mesh stop painful hernias after surgery?

NCT ID NCT03911700

Prevention Sponsor: C. R. Bard Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 2 times

Summary

This study tests whether placing a special mesh (Phasix) during abdominal closure can prevent incisional hernias in people at high risk. About 477 adults having open abdominal surgery will be randomly assigned to get the mesh or standard stitches. The main goal is to see if the mesh reduces hernia rates over time.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

477 people

The number who actually took part.

Started

Dec 2019

Expected to finish

Aug 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Open midline laparotomy

Contacts and locations

Locations

  • Asklepios Klinik Barmbek

    Hamburg, Germany, 22307, Germany

  • Atrium Health

    Charlotte, North Carolina, 28203, United States

  • Baptist Clinical Research Institute

    Memphis, Tennessee, 38163, United States

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Bundeswehrzentralkrankenhaus Koblenz

    Koblenz, 56072, Germany

  • CAMC Health Education and Research Institute, Inc.

    Charleston, West Virginia, 25304, United States

  • CHU Reims

    Reims, 51092, France

  • CHU de Dijon Bourgogne

    Dijon, 21079, France

  • Centre Hospitalier Universitaire de Lille

    Lille, France, 59000, France

  • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology

    Berlin, 13353, Germany

  • Dignity Health

    Phoenix, Arizona, 85013, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Hartford Hospital

    Hartford, Connecticut, 06102, United States

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67000, France

  • Hôpital Lyon Sud

    Pierre-Bénite, 69495, France

  • Hôpital Paris St Joseph

    Paris, 75014, France

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Krankenhaus der Barmherzigen Brüder Graz

    Graz, 08020, Austria

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • New Hanover Regional Medical Center

    Wilmington, North Carolina, 28401, United States

  • New York Presbyterian Hospital-Columbia University Medical Center

    New York, New York, 10032, United States

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112, United States

  • Universitair Ziekenhuis Gent

    Ghent, 09000, Belgium

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Kentucky Research Foundation

    Lexington, Kentucky, 40508, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

  • Washington University

    St Louis, Missouri, 63110, United States