AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

Last updated: December 27, 2024
Sponsor: Kerecis Ltd.
Overall Status: Active - Not Recruiting

Phase

4

Condition

Soft Tissue Infections

Treatment

Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT)

Acellular Fish Skin Graft (AFS) and Negative Pressure Wound Therapy (NPWT)

Acellular Human Cadaver (AHC) with Standard of care Negative Pressure Wound Therapy (NPWT)

Clinical Study ID

NCT06073301
KS-0820
  • Ages > 18
  • All Genders

Study 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. The purpose of this study is to compare clinical outcomes and time until autograft take in patients that were treated with AHC or AFS prior to permanent autografting to treat NF.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Is ≥18 years of age.

  • Has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta orAdvanced Wound Clinic for treatment of NF which has been treated and is consideredstable.

Exclusion

Exclusion Criteria:

  • Subject has been previously enrolled into this study or is currently participatingin 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.

Study Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT)
Phase: 4
Study Start date:
August 01, 2023
Estimated Completion Date:
December 01, 2025

Study 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 compared to subjects treated with acellular human cadaver skin to prepare the wound bed prior to grafting. Subjects eligible to receive study treatment will be any adult patient (18 years of age or older) admitted to the Joseph M. Still Burn Center or Advanced Wound Clinic at Doctors Hospital Augusta with a diagnosis of NF that has been treated and is stable. Prior wound excisions will be allowed until the surgeon has deemed the wound stable and free from necrotizing processes.

Exclusion criteria will be positive pregnancy test on admission, subject has active diagnosis of any autoimmune process, or cancer that in the opinion of the investigator would prevent the subject from successfully participating in the study.

Connect with a study center

  • Joseph M. Still Research Foundation

    Augusta, Georgia 30909
    United States

    Site Not Available

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