Prophylactic Reinforcement of Ventral Abdominal Incisions Trial (PREVENT)

C. R. Bard

Status: Enrolling

Conditions: Open Midline Laparotomy

Treatments: Device: Phasix™ Mesh

Study type: Interventional

Funder types: Industry

Identifiers

NCT03911700

DVL-HE-018

Details and patient eligibility

About

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.

Full description

Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.

Enrollment: 477 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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477 participants in 2 patient groups

Phasix™ Mesh

Experimental group

Description:

Prophylactic onlay placement of mesh.

Treatment:

Device: Phasix™ Mesh

Primary Suture Closure

No Intervention group

Description:

Standard Fascial closure.