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Prophylactic Reinforcement of Ventral Abdominal Incisions Trial (PREVENT)

C

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

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.

Trial contacts and locations

37

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Central trial contact

Jaime Ritter, MPH; Amanda Resendes, MBA

Data sourced from clinicaltrials.gov

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