Status:
UNKNOWN
A Prospective, Double-Blinded, Randomized Controlled Trial of dHACM for Incisional Hernia Prophylaxis
Lead Sponsor:
Louisiana State University Health Sciences Center in New Orleans
Collaborating Sponsors:
LSUHSC-NO
Conditions:
Incisional Hernia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Currently, no standard of care exists to prevent incisional hernias (IH). This study will compare how frequently IH develop in standard abdominal closures vs. abdominal closures with dHACM added. By a...
Detailed Description
Two million laparotomies are performed annually in the United States (US). Following these surgeries, the incidence of new incisional hernias (IH) is estimated at 400,000 cases per year. These hernias...
Eligibility Criteria
Inclusion
- Patient \> 18 years
- Written informed consent
- Non-emergent operation
- Predicted incisional herna (IH) risk ≥150% of the average IH risk, as calculated by the University of Pennsylvania Hernia Risk Calculator, which accounts for 18 IH risk factors
- BMI \> 27 yields IH risk \> 150% of the average IH risk; this can be used as a shortcut for screening potential subjects
Exclusion
- Previous intraperitoneal mesh placement
- Previous abdominal incisional hernia
- Emergency procedures
- Patients with inflammatory bowel disease
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2022
Estimated Enrollment :
533 Patients enrolled
Trial Details
Trial ID
NCT04417140
Start Date
May 20 2020
End Date
May 20 2022
Last Update
June 4 2020
Active Locations (1)
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1
University Medical Center
New Orleans, Louisiana, United States, 70112