Trials / Recruiting
RecruitingNCT03911700
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Prospective, Multi-Center, Open-Label, Randomized, Controlled Trial of Phasix™ Mesh to Prevent Incisional Hernia Subsequent to Open Midline Laparotomy
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 477 (estimated)
- Sponsor
- C. R. Bard · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Subjects will be randomized (1:1) to one of the two treatment groups in the operating room after fascial closure.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Phasix™ Mesh | Phasix™ Mesh is a resorbable mesh prepared from Poly-4-hydroxybutyrate (P4HB). |
Timeline
- Start date
- 2019-12-12
- Primary completion
- 2029-12-01
- Completion
- 2031-12-01
- First posted
- 2019-04-11
- Last updated
- 2026-02-25
Locations
44 sites across 5 countries: United States, Austria, Belgium, France, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03911700. Inclusion in this directory is not an endorsement.