Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
C. R. Bard
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.
Description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 dire…
Interventions
- DevicePhasix™ Mesh
Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB).
Locations (44)
- Dignity HealthPhoenix, Arizona
- Keck Medical Center of USCLos Angeles, California
- University of California San FranciscoSan Francisco, California
- Hartford HospitalHartford, Connecticut
- St. Francis Hospital and Medical CenterHartford, Connecticut
- Emory UniversityAtlanta, Georgia