AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

NCT06073301 · tracked via the Priya Life Science USA tracker

Sponsor

Kerecis Ltd

Phase

Phase 4

Started

2023-08-01

Last updated

2024-12-30

Condition(s) studied

Necrotizing Fasciitis

Investigational drug(s) / intervention(s)

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

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.

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.

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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Primary endpoint: To compare the time from first application of study product to time of autografting between the two study groups. — 9 weeks
To compare the time (number of days) from the first application of study product to time (number of days ) to autografting.

Trial sites (1)

Facility	City	Region	Status
Joseph M. Still Research Foundation	Augusta	Georgia

More Kerecis Ltd. trials in the USA

Kerecis Case Registry for SurgiBind : Soft Tissue Reinforcement Active, not recruiting

Prospective Case Registry for Wounds Active, not recruiting

Evaluating the Durability of Closure for Venous Leg Ulcers Recruiting

Evaluating Intact Fish Skin Graft and Standard of Care Versus Standard of Care Alone in Nonhealing Venous Leg Ulcers Recruiting

Omega3 Wound Fish Skin Graft in the Treatment of DFUs Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06073301 on ClinicalTrials.gov ↗ ← All trials in the USA