Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
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