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AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

NCT06073301 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-30

No results posted yet for this 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.

Conditions

  • Necrotizing Fasciitis

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.

Sponsors & Collaborators

  • Joseph M. Still Research Foundation, Inc.

    collaborator OTHER

  • Kerecis Ltd.

    lead INDUSTRY

Principal Investigators

  • Bounthavy Homsombath, MD · Joseph M.Still Research Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-08-01
Completion
2025-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06073301 on ClinicalTrials.gov