A Phase 4 interventional study of Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT) and Acellular Human Cadaver (AHC) with Standard of care Negative Pressure Wound Therapy (NPWT) in Necrotizing Fasciitis, sponsored by Kerecis Ltd.. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-30.
Sponsored by Kerecis Ltd. (part of Coloplast A/S) · Phase 4, Interventional, and Treatment
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.
This will be a prospective, randomized, open-label, interventional, single-center study looking at time to autograft placement and time to full closure in subjects treated with acellular fish skin compared to subjects treated with acellular human cadaver skin to prepare the wound bed prior to grafting. Subjects eligible to receive study treatment will be any adult patient (18 years of age or older) admitted to the Joseph M. Still Burn Center or Advanced Wound Clinic at Doctors Hospital Augusta with a diagnosis of NF that has been treated and is stable. Prior wound excisions will be allowed until the surgeon has deemed the wound stable and free from necrotizing processes.
Exclusion criteria will be positive pregnancy test on admission, subject has active diagnosis of any autoimmune process, or cancer that in the opinion of the investigator would prevent the subject from successfully participating in the study.
28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.
This study's planned enrollment of 30 is below the median of 74 across 12 interventional studies indexed under Fasciitis, Necrotizing.
Browse Fasciitis, Necrotizing studies →Kerecis Ltd. is the lead sponsor of 14 studies on the registry; 4 are open to participants now.
First submitted after Kerecis Ltd. became part of Coloplast A/S.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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)
.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)
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
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
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.
Time frame: 9 weeks
Secondary Endpoint: To compare the percentage of autograft take between the two study groups.
To measure the percentage from 0 to 100% of autograft adherence to the wound bed
Time frame: 9 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Aug 2025, 24 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.