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.
- Rutgers Cancer Institute of New Jersey
- RWJBarnabas Health
- Cooperman Barnabas, Livingston
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
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.
For further information about clinical trials, please contact us at 732-235-7356.