AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF — NF  

Necrotizing Fasciitis Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Necrotizing
• Necrotizing Fasciitis

• NCT number: NCT06073301
• Study type: Interventional
• Source: Kerecis Ltd.
• Contact: Joanie Wilson, MSN,MHA,RN
• Phone: 706-364-2966
• Email: Joan.Wilson@jmsresearchfoundation.org
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2023
• Completion date: December 1, 2025