AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

Necrotizing Fasciitis Clinical Trial

— NF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06073301
• Other study ID #: KS-0820
• Status: Recruiting
• Phase: Phase 4
• Start date: August 1, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: March 2024
• Source: Kerecis Ltd.
• Contact: Joanie Wilson, MSN,MHA,RN
• Phone: 706-364-2966
• Email: Joan.Wilson[@]jmsresearchfoundation.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2025
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Necrotizing
• Necrotizing Fasciitis

Intervention

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

Country	Name	City	State
United States	Joseph M. Still Research Foundation	Augusta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Kerecis Ltd.	Joseph M. Still Research Foundation, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: To compare the time from first application of study product to time of autografting between the two study groups.	To compare the time (number of days) from the first application of study product to time (number of days ) to autografting.	9 weeks
Secondary	Secondary Endpoint: To compare the percentage of autograft take between the two study groups.	To measure the percentage from 0 to 100% of autograft adherence to the wound bed	9 weeks