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NCT Number: NCT06073301

AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Necrotizing Fasciitis Fasciitis Fasciitis, Necrotizing Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Joseph M. Still Research Foundation

Augusta, Georgia, 30909, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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

Device

Acellular Fish Skin, used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take.

Other names: Brand Kerecis: GraftGuide, GraftGuide Micro, GraftGuide Meshed

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

Other

Acellular Human Cadaver , used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take.

Other names: AHC

Primary outcomes

  1. Primary endpoint: To compare the time from first application of study product to time of autografting between the two study groups.

    Time frame: 9 weeks

    To compare the time (number of days) from the first application of study product to time (number of days ) to autografting.

Secondary outcomes

  1. Secondary Endpoint: To compare the percentage of autograft take between the two study groups.

    Time frame: 9 weeks

    To measure the percentage from 0 to 100% of autograft adherence to the wound bed

Sponsors and collaborators

Lead sponsor

Kerecis Ltd.

Industry

Collaborators

  • Joseph M. Still Research Foundation, Inc.

Registry information

Official study title

Comparison of Treatment with Acellular Fish Skin (AFS) to Acellular Human Cadaver Allograft (AHC) in the Treatment of Necrotizing Fasciitis (NF)

Acronym: NF

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2023
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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