Status:
ACTIVE_NOT_RECRUITING
AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF
Lead Sponsor:
Kerecis Ltd.
Collaborating Sponsors:
Joseph M. Still Research Foundation, Inc.
Conditions:
Necrotizing Fasciitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Necrotizing Fasciitis (NF) is a potentially life-threatening soft tissue infection. This study is comparing acellular fish skin graft (AFS) to standard of care allograft (AHC) in the treatment of NF. ...
Detailed Description
This will be a prospective, randomized, open-label, interventional, single-center study looking at time to autograft placement and time to full closure in subjects treated with acellular fish skin com...
Eligibility Criteria
Inclusion
- Is ≥18 years of age.
- Has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta or Advanced Wound Clinic for treatment of NF which has been treated and is considered stable.
Exclusion
- Subject has been previously enrolled into this study or is currently participating in another drug or device study that has not reached its primary endpoint.
- Index wounds that due to anatomical location are unable to apply a NPWT device.
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06073301
Start Date
August 1 2023
End Date
December 1 2025
Last Update
December 30 2024
Active Locations (1)
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1
Joseph M. Still Research Foundation
Augusta, Georgia, United States, 30909