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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

NF 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.Check my eligibility

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.See study design

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.

NF Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

NF Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

NF 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

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Who is running the clinical trial?

Kerecis Ltd.Lead Sponsor

11 Previous Clinical Trials

1,897 Total Patients Enrolled

Joseph M. Still Research Foundation, Inc.OTHER

8 Previous Clinical Trials

328 Total Patients Enrolled

Bounthavy Homsombath, MDPrincipal InvestigatorJoseph M.Still Research Foundation

1 Previous Clinical Trials

50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are Acellular Fish Skin (AFS) and Negative Pressure Wound Therapy (NPWT) sanctioned by the FDA?

"The safety of Acellular Fish Skin (AFS) and Negative Pressure Wound Therapy (NPWT), both of which are approved treatments, is estimated to be a 3 due to the existence of Phase 4 trial data."

Answered by AI

Is there still capacity for new participants in this research endeavor?

"Per clinicaltrials.gov, this medical examination is actively recruiting participants. It was first published on August 1st 2023 and the information was most recently revised on October 2nd of the same year."

Answered by AI

How many participants are actively involved in this research initiative?

"Affirmative. According to clinicaltrials.gov, the medical trial is at present recruiting patients after first being posted on August 1st 2023 and revised most recently on October 2nd 2023. The study requires 30 participants from a single site for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

2023. "AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06073301.

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