AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

NCT06073301 | Active Not Recruiting Phase 4 FDA Device

• 1 other identifier: KS-0820
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Fasciitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Secondary Endpoint: To compare the percentage of autograft take between the two study groups.

  9 weeks

Study Arms (2)

Treatment: Acellular Fish Skin (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT)

EXPERIMENTAL

Eligible subjects will be randomized electronically to either the Acellular Fish Skin (AFS)arm. The subject will undergo wound bed preparation by surgical debridement. the AFS will be applied to the wound bed and secured with sutures, the size of the AFS will be determined after surgical debridement. Once the AFS is in place a Negative Pressure Wound Therapy device will be placed. the subject will be monitored weekly on scheduled intervals of +/- 4 days post AFS placement to assess the status of the wound and readiness for autografting. Once the wound is ready for autografting the subject will be monitored for autograft take, for up to 9 visits. Long term follow-up will be done at month 3, 6, 9 post autograft placement

Device: Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT)

Acellular Human Cadaver with Standard of Care Negative Pressure Wound Therapy (NPWT)

ACTIVE COMPARATOR

.Eligible subjects will be randomized electronically to standard of care arm which is Acellular Human Cadaver (AHC) The subject will undergo wound bed preparation by surgical debridement. The AHC will be applied to the wound bed and secured with sutures, the size of the AHC will be determined after surgical debridement. Once the AHC is in place a Negative Pressure Wound Therapy device will be placed. the subject will be monitored weekly on scheduled intervals of +/- 4 days post AHC placement to assess the status of the wound and readiness for autografting. Once the wound is ready for autografting the subject will be monitored for autograft take, for up to 9 visits. Long term follow-up will be done at month 3, 6, 9 post autograft placement

Other: Acellular Human Cadaver (AHC) with Standard of care Negative Pressure Wound Therapy (NPWT)

Interventions

Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT) DEVICE

Acellular Fish Skin, used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take.

Also known as: Brand Kerecis: GraftGuide, GraftGuide Micro, GraftGuide Meshed

Treatment: Acellular Fish Skin (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT)

Acellular Human Cadaver (AHC) with Standard of care Negative Pressure Wound Therapy (NPWT) OTHER

Acellular Human Cadaver , used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take.

Also known as: AHC

Acellular Human Cadaver with Standard of Care Negative Pressure Wound Therapy (NPWT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kerecis Ltd.: lead
• Joseph M. Still Research Foundation, Inc.: collaborator

Study Sites (1)

Joseph M. Still Research Foundation

Augusta, Georgia, 30909, United States

Location

MeSH Terms

Conditions

Fasciitis, Necrotizing

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases

Study Officials

• Bounthavy Homsombath, MD

  Joseph M.Still Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligible Subjects for this single center open label randomized study, will randomize eligible subjects to 2 groups, 15 in the treatment arm (Fish skin graft) and 15 in the control arm (cadaver graft). Randomization will be done electronically on day of surgery, enrollment.

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 10, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)