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Procedure

AFS vs. AHC Grafts for Flesh-Eating Disease (NF Trial)

Phase 4

Recruiting

Led By Bounthavy Homsombath, MD

Research Sponsored by Kerecis Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is ≥18 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 weeks

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two treatments for Necrotizing Fasciitis to find better clinical outcomes and quicker recovery times.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include infection, allergic reactions, inflammation at the treatment site, and complications related to wound healing processes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary endpoint: To compare the time from first application of study product to time of autografting between the two study groups.

Secondary study objectives

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

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment: Acellular Fish Skin (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT)Experimental Treatment1 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 Control1 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

0 / 1Eligibility criteria met