Prophylactic Reinforcement of Ventral Abdominal Incisions Trial

a study on Laparotomy Hernia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

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.

Official Title

Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy

Details

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

Keywords

Open Midline Laparotomy, Phasix™ Mesh

Eligibility

You can join if…

Open to people ages 18 years and up

  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

You CAN'T join if...

  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

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States
  • Keck Medical Center of USC withdrawn
    Los Angeles California 90033 United States
  • Dignity Health accepting new patients
    Phoenix Arizona 85013 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
C. R. Bard
ID
NCT03911700
Study Type
Interventional
Participants
Expecting 477 study participants
Last Updated