Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- C. R. Bard
- Study ID
- NCT03911700
- Status
- Recruiting
Conditions
- Open Midline Laparotomy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Phasix™ Mesh — DEVICEPhasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
Study Details
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 Dates
- Start date
- Dec 12, 2019
- Status verified
- Feb 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2031
Study Design
- Enrollment
- 477 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: Phasix™ MeshProphylactic onlay placement of mesh.
- No Intervention: Primary Suture ClosureStandard Fascial closure.
Primary Outcome Measure
Rate of Incisional Hernia [ Time Frame: 24-Months ]
Central Contacts
- Amanda Resendes, MBA401-209-7141
- Jaime Ritter, MPH404-327-1221
Locations (30)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Dignity Health | Phoenix | Arizona | 85013 | Hahn Soe-Lin, MD (PRINCIPAL_INVESTIGATOR) |
| Keck Medical Center of USC | Los Angeles | California | 90033 | - |
| University of California San Francisco | San Francisco | California | 94143 | Hobart Harris, MD (PRINCIPAL_INVESTIGATOR) |
| Hartford Hospital | Hartford | Connecticut | 06102 | - |
| St. Francis Hospital and Medical Center | Hartford | Connecticut | 06105 | - |
| Emory University | Atlanta | Georgia | 30322 | - |
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | - |
| Indiana University | Indianapolis | Indiana | 46202 | - |
| University of Kentucky Research Foundation | Lexington | Kentucky | 40508 | Scott J Roth, MD (PRINCIPAL_INVESTIGATOR) |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | Jennifer Silinsky, MD (PRINCIPAL_INVESTIGATOR) |
| University of Michigan | Ann Arbor | Michigan | 48109 | - |
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | - |
| University of Minnesota | Minneapolis | Minnesota | 55455 | Wolfgang Gaertner, MD (PRINCIPAL_INVESTIGATOR) |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | - |
| Cox Health | Springfield | Missouri | 65807 | - |
| Washington University | St Louis | Missouri | 63110 | William Chapman, MD (PRINCIPAL_INVESTIGATOR) |
| Nebraska Medical Center | Omaha | Nebraska | 68106 | - |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | - |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08901 | Henry Alexander, MD (PRINCIPAL_INVESTIGATOR) |
| New York Presbyterian Hospital-Columbia University Medical Center | New York | New York | 10032 | - |
| Montefiore Medical Center | The Bronx | New York | 10467 | - |
| Atrium Health | Charlotte | North Carolina | 28203 | - |
| Duke University | Durham | North Carolina | 27708 | - |
| New Hanover Regional Medical Center | Wilmington | North Carolina | 28401 | William Hope, MD (PRINCIPAL_INVESTIGATOR) |
| The Ohio State University | Columbus | Ohio | 43210 | Benjamin Poulose, MD (PRINCIPAL_INVESTIGATOR) |
| Oregon Health & Science University | Portland | Oregon | 97239 | - |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Robert Roses, MD (PRINCIPAL_INVESTIGATOR) |
| Baptist Clinical Research Institute | Memphis | Tennessee | 38163 | - |
| Vanderbilt University | Nashville | Tennessee | 37232 | Richard Pierce, MD (PRINCIPAL_INVESTIGATOR) |
| CAMC Health Education and Research Institute, Inc. | Charleston | West Virginia | 25304 | - |