Prophylactic Reinforcement of Ventral Abdominal Incisions Trial (PREVENT): Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy.
This trial is being conducted to evaluate the efficacy of Phasix Mesh implantation at the time of midline fascial closure in preventing a subsequent incisional hernia in subjects at risk for incisional hernia after open midline laparotomy surgery. It is anticipated that Phasix Mesh implantation will increase the strength of the closure compared to standard fascial closure methods (Control Group, Primary Suture Closure), in subjects at risk for incisional hernia after open midline laparotomy surgery.
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
- Robert Wood Johnson University Hospital, New Brunswick
- Rutgers University
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 36 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
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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