Summary

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

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

Locations

  • 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  • Keck Medical Center of USC withdrawn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) 110 research publications

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