Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
C. R. Bard
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.
Description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No