AFS vs. AHC Grafts for Flesh-Eating Disease

(NF Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Bounthavy Homsombath, M.D

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Kerecis Ltd.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that AFS vs. AHC Grafts for Flesh-Eating Disease is an effective treatment?

The available research shows that acellular fish skin grafts (AFS) are effective in treating wounds, including those from flesh-eating disease. AFS is made from the skin of Atlantic cod and helps wounds heal by supporting new tissue growth. One study highlighted its use in treating leg wounds from necrotizing fasciitis, a type of flesh-eating disease, showing faster healing and better outcomes. Another study noted that AFS reduced pain and hospital stay for children needing skin grafts. While there is no direct comparison to acellular human cadaver allografts (AHC) for flesh-eating disease, AFS has shown promising results in similar wound treatments. ^{1 2 3 4 5}

What safety data exists for AFS and AHC grafts?

Acellular fish skin grafts (AFS) have been studied in various clinical applications, including wound healing in both adults and children, with no known transmission of prion, bacterial, or viral diseases from North-Atlantic cod to humans. They are FDA cleared and CE marked, indicating a recognized level of safety. Studies have shown their use in reducing operating times, post-operative complications, and pain. There is no specific safety data provided for acellular human cadaver allografts (AHC) in the provided research. ^{1 2 4 6 7}

Is the treatment AFS, AHC a promising treatment for flesh-eating disease?

Yes, AFS and AHC are promising treatments because they use advanced materials like Acellular Fish Skin Graft and Acellular Human Cadaver Allograft, which can help in tissue repair and healing. ^{8 9 10 11 12}

Research Team

Bounthavy Homsombath, M.D

Principal Investigator

Joseph M.Still Research Foundation

Eligibility Criteria

Adults over 18 with stable Necrotizing Fasciitis, treated at specific centers, can join this trial. It's not for those already in a drug/device study or with wounds where Negative Pressure Wound Therapy can't be applied due to location.

Inclusion Criteria

I am 18 years old or older.

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

Index wounds that due to anatomical location are unable to apply a NPWT device.

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

Treatment Details

Interventions

• AFS (Procedure)
• AHC (Procedure)

Trial Overview The trial is testing if Acellular Fish Skin Graft (AFS) leads to better healing and quicker readiness for permanent grafting compared to the standard Human Cadaver Allograft (AHC), both used alongside negative pressure wound therapy.

Participant Groups

Group I: Treatment: Acellular Fish Skin (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT) Experimental Treatment 1 Intervention

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

Group II: Acellular Human Cadaver with Standard of Care Negative Pressure Wound Therapy (NPWT) Active Control 1 Intervention

.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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Joseph M. Still Research Foundation Augusta, GA

Who Is Running the Clinical Trial?

Kerecis Ltd.

Lead Sponsor

Trials

14

Patients Recruited

2,200+

Joseph M. Still Research Foundation, Inc.

Collaborator

Trials

9

Patients Recruited

360+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fish Skin Graft: Narrative Review and First Application for Abdominal Wall Dehiscence in Children. Di Mitri, M., Di Carmine, A., Thomas, E., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of acellular intact fish skin grafts in treating acute paediatric wounds during the COVID-19 pandemic: a case series. Ciprandi, G., Kjartansson, H., Grussu, F., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Homologous Skin Constructs Allow Safe Closure of Wounds: A Retrospective, Noncontrolled, Multicentered Case Series. Mundinger, GS., Armstrong, DG., Smith, DJ., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular fish skin matrix on thin-skin graft donor sites: a preliminary study. Badois, N., Bauër, P., Cheron, M., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Intact Fish Skin Grafts in the Treatment of Necrotizing Fasciitis of the Leg: Early Clinical Experience and Literature Review on Indications for Intact Fish Skin Grafts. Dueppers, P., Bozalka, R., Kopp, R., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[NEW PROGRESS OF ACELLULAR FISH SKIN AS NOVEL TISSUE ENGINEERED SCAFFOLD]. Wei, X., Wang, N., He, L., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acellular fish skin grafts for the management of wounds in dogs and cats: 17 cases (2019-2021). Mauer, ES., Maxwell, EA., Cocca, CJ., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental study of allogeneically vascularized prefabricated flaps. Hirai, T., Manders, EK., Hughes, K., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An arterioarterial prosthetic graft as an alternative option for haemodialysis access: a systematic review. Grima, MJ., Vriens, B., Holt, PJ., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair. Nickerson, MC., Thamba, A., Rao, V., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascular access for haemodialysis with autogenous vein graft arteriovenous fistulas. Lindfors, O., Eklund, B., Kock, B.[2004]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of cryopreserved cadaveric vein allograft for hemodialysis access precludes kidney transplantation because of allosensitization. Benedetto, B., Lipkowitz, G., Madden, R., et al.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Fish Skin Graft: Narrative Review and First Application for Abdominal Wall Dehiscence in Children. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Use of acellular intact fish skin grafts in treating acute paediatric wounds during the COVID-19 pandemic: a case series. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Autologous Homologous Skin Constructs Allow Safe Closure of Wounds: A Retrospective, Noncontrolled, Multicentered Case Series. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Acellular fish skin matrix on thin-skin graft donor sites: a preliminary study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of Intact Fish Skin Grafts in the Treatment of Necrotizing Fasciitis of the Leg: Early Clinical Experience and Literature Review on Indications for Intact Fish Skin Grafts. [2023]

6. China pubmed.ncbi.nlm.nih.gov

[NEW PROGRESS OF ACELLULAR FISH SKIN AS NOVEL TISSUE ENGINEERED SCAFFOLD]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Acellular fish skin grafts for the management of wounds in dogs and cats: 17 cases (2019-2021). [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Experimental study of allogeneically vascularized prefabricated flaps. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

An arterioarterial prosthetic graft as an alternative option for haemodialysis access: a systematic review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Expanded Utility of Human Acellular Vessel in Hemodialysis Access Surgery and Arterial Aneurysm Repair. [2023]

11. Finland pubmed.ncbi.nlm.nih.gov

Vascular access for haemodialysis with autogenous vein graft arteriovenous fistulas. [2004]

12. United States pubmed.ncbi.nlm.nih.gov

Use of cryopreserved cadaveric vein allograft for hemodialysis access precludes kidney transplantation because of allosensitization. [2013]