Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

Recruiting now · Not applicable

Conditions studied: Open Midline Laparotomy

In brief

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.

Key facts

Study ID

NCT03911700

Run by

C. R. Bard

People needed

477

Starts

2019-12-12

Expected to finish

2031-12-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Surgeon is unable to fully close the fascia
• The surgery requires more than a single piece of mesh
• Contraindication to placement of mesh
• CDC Class IV/Active Infection
• Breastfeeding

Where it is running

• Dignity Health — Phoenix, Arizona, United States (enrolling)
• University of California San Francisco — San Francisco, California, United States (enrolling)
• University of Kentucky Research Foundation — Lexington, Kentucky, United States (enrolling)
• Tulane University School of Medicine — New Orleans, Louisiana, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• Washington University — St Louis, Missouri, United States (enrolling)
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States (enrolling)
• New Hanover Regional Medical Center — Wilmington, North Carolina, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• Vanderbilt University — Nashville, Tennessee, United States (enrolling)
• Krankenhaus der Barmherzigen Brüder Graz — Graz, Austria (enrolling)
• Universitair Ziekenhuis Gent — Ghent, Belgium (enrolling)
• CHU de Dijon Bourgogne — Dijon, France (enrolling)
• Centre Hospitalier Universitaire de Lille — Lille, France (enrolling)
• Centre Hospitalier Universitaire de Lille — Lille, France (enrolling)
• Hôpital Paris St Joseph — Paris, France (enrolling)
• Hôpital Lyon Sud — Pierre-Bénite, France (enrolling)
• CHU Reims — Reims, France (enrolling)
• Hopitaux Universitaires de Strasbourg — Strasbourg, France (enrolling)
• Asklepios Klinik Barmbek — Hamburg, Germany (enrolling)
• Universitätsklinikum Heidelberg — Heidelberg, Germany (enrolling)
• Bundeswehrzentralkrankenhaus Koblenz — Koblenz, Germany (enrolling)
• Keck Medical Center of USC — Los Angeles, California, United States
• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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