Active — Not RecruitingPhase 4

AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF

United States30 participantsStarted 2023-08-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: 9 weeks

Trial details

NCT IDNCT06073301

SponsorKerecis Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-01

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