AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

Phase 4

Active, not recruiting

• Conditions: Necrotizing Fasciitis

• Registration Number: NCT06073301
• Lead Sponsor: Kerecis Ltd.

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-10-02
• Study First Posted: 2023-10-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-12-27
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-08-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoint: To compare the percentage of autograft take between the two study groups.	9 weeks	To measure the percentage from 0 to 100% of autograft adherence to the wound bed

Trial Locations

Locations (1)

Joseph M. Still Research Foundation; 🇺🇸 Augusta, Georgia, United States