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ACTIVE NOT RECRUITING
NCT06073301
PHASE4

AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

Sponsor: Kerecis Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-08-01

Completion Date

2025-12-01

Last Updated

2024-12-30

Healthy Volunteers

No

Interventions

DEVICE

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

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

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

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

Locations (1)

Joseph M. Still Research Foundation

Augusta, Georgia, United States