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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Joseph M. Still Research Foundation

Augusta, Georgia, United States, 30909