for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
completion around
Principal Investigator
by Hobart Harris, MD
Headshot of Hobart Harris
Hobart Harris



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


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


Open Midline Laparotomy, Phasix™ Mesh


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


  • UCSF 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  • Keck Medical Center of USC withdrawn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

Lead Scientist at UCSF

  • Hobart Harris, MD
    Professor, Surgery, School of Medicine. Authored (or co-authored) 108 research publications


accepting new patients
Start Date
Completion Date
C. R. Bard
Study Type
Expecting 477 study participants
Last Updated