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Active, not recruiting Not applicable

Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

NCT03911700 · tracked via the Priya Life Science France tracker
Sponsor
Phase
Not applicable
Started
2019-12-12
Last updated
2026-08-20

Condition(s) studied

Open Midline Laparotomy

Investigational drug(s) / intervention(s)

Phasix™ Mesh

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Rate of Incisional Hernia — 24-Months
    The primary endpoint of the trial is the occurrence of incisional hernia in each treatment group (Phasix™ Mesh or Control Group)

Trial sites (33)

FacilityCityRegionStatus
Dignity Health Phoenix Arizona
University of California San Francisco San Francisco California
Hartford Hospital Hartford Connecticut
Emory University Atlanta Georgia
OSF Saint Francis Medical Center Peoria Illinois
Indiana University Indianapolis Indiana
University of Kentucky Research Foundation Lexington Kentucky
Tulane University School of Medicine New Orleans Louisiana
Boston Medical Center Boston Massachusetts
University of Minnesota Minneapolis Minnesota
Washington University St Louis Missouri
Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
New York Presbyterian Hospital-Columbia University Medical Center New York New York
Montefiore Medical Center The Bronx New York
Atrium Health Charlotte North Carolina
New Hanover Regional Medical Center Wilmington North Carolina
The Ohio State University Columbus Ohio
University of Pennsylvania Philadelphia Pennsylvania
Baptist Clinical Research Institute Memphis Tennessee
Vanderbilt University Nashville Tennessee
CAMC Health Education and Research Institute, Inc. Charleston West Virginia
Krankenhaus der Barmherzigen Brüder Graz Graz Austria
Universitair Ziekenhuis Gent Ghent Belgium
Centre Hospitalier Universitaire de Lille Lille France
CHU de Dijon Bourgogne Dijon France
Hôpital Paris St Joseph Paris France
Hôpital Lyon Sud Pierre-Bénite France
CHU Reims Reims France
Hopitaux Universitaires de Strasbourg Strasbourg France
Asklepios Klinik Barmbek Hamburg Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Gyneocology Berlin Germany
Universitätsklinikum Heidelberg Heidelberg Germany
Bundeswehrzentralkrankenhaus Koblenz Koblenz Germany

More C. R. Bard trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03911700 on ClinicalTrials.gov ↗ ← All trials in France