Necrotizing FasciitisPhase 4NFNCT06073301
AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF
A Phase 4 study of Necrotizing Fasciitis, run by Kerecis Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotizing Fasciitis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 1 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Joseph M. Still Research Foundation
Augusta, Georgia, 30909
About this study
Official title: Comparison of Treatment with Acellular Fish Skin (AFS) to Acellular Human Cadaver Allograft (AHC) in the Treatment of Necrotizing Fasciitis (NF)
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.
Read the detailed description
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.
- Conditions
- Necrotizing Fasciitis
- Being tested
- Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT), Acellular Human Cadaver (AHC) with Standard of care Negative Pressure Wound Therapy (NPWT)
- Medical subject headings
- Fasciitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT)Device
Also called Brand Kerecis: GraftGuide, GraftGuide Micro, GraftGuide Meshed
Acellular Fish Skin, used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take.
Acellular Human Cadaver (AHC) with Standard of care Negative Pressure Wound Therapy (NPWT)Other
Also called AHC
Acellular Human Cadaver , used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: Acellular Fish Skin (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT) | Experimental | 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 Receives: Device: Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT) |
| Acellular Human Cadaver with Standard of Care Negative Pressure Wound Therapy (NPWT) | Active comparator | .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 Receives: Other: Acellular Human Cadaver (AHC) with Standard of care Negative Pressure Wound Therapy (NPWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 weeks
Secondary outcomes (1)
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
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start1 Aug 2023
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible Subjects for this single center open label randomized study, will randomize eligible subjects to 2 groups, 15 in the treatment arm (Fish skin graft) and 15 in the control arm (cadaver graft). Randomization will be done electronically on day of surgery, enrollment.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerecis Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Joseph M. Still Research Foundation, Inc.
- Responsible party
- Sponsor
- Investigators
- Bounthavy Homsombath, MD, Principal investigator, Joseph M.Still Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073301
- Sponsor's protocol ID
- KS-0820
- Acronym
- NF
- Status last verified
- Oct 2024
- First submitted
- 21 Sep 2023
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment with Acellular Fish Skin (AFS) to Acellular Human Cadaver Allograft (AHC) in the Treatment of Necrotizing Fasciitis (NF)
- ClinicalTrials.gov ID
- NCT06073301
- Acronym / sponsor ID
- NF / KS-0820
- Conditions
- Necrotizing Fasciitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kerecis Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Joseph M. Still Research Foundation, Inc.
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible Subjects for this single center open label randomized study, will randomize eligible subjects to 2 groups, 15 in the treatment arm (Fish skin graft) and 15 in the control arm (cadaver graft). Randomization will be done electronically on day of surgery, enrollment.
| Arm | Type | Receives |
|---|---|---|
| Treatment: Acellular Fish Skin (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT) | Experimental | Device: Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT)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 |
| Acellular Human Cadaver with Standard of Care Negative Pressure Wound Therapy (NPWT) | Active comparator | Other: Acellular Human Cadaver (AHC) 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT)Also: Brand Kerecis: GraftGuide, GraftGuide Micro, GraftGuide MeshedAcellular Fish Skin, used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take. | Device | Treatment: Acellular Fish Skin (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT) |
| Acellular Human Cadaver (AHC) with Standard of care Negative Pressure Wound Therapy (NPWT)Also: AHCAcellular Human Cadaver , used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take. | Other | Acellular Human Cadaver with Standard of Care Negative Pressure Wound Therapy (NPWT) |
Primary outcome
Primary endpoint: To compare the time from first application of study product to time of autografting between the two study groups.
Time frame: 9 weeks
To compare the time (number of days) from the first application of study product to time (number of days ) to autografting.
1 secondary outcome
Secondary Endpoint: To compare the percentage of autograft take between the two study groups.
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bounthavy Homsombath, MD principal investigator
Joseph M.Still Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Necrotizing Fasciitis, run by Kerecis Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: To compare the time from first application of study product to time of autografting between the two study groups. (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2024.