Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Recruiting
N/A
Interventional Study
Open Midline Laparotomy
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 477 (estimated)
- Sponsor
- C. R. Bard · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
1. Previous hernia repair
2. Emergent surgery
3. Creation of skin flaps is preplanne…
Contacts