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| Name | Class |
|---|---|
| Joseph M. Still Research Foundation, Inc. | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acellular Fish Skin Graft (AFS) with Standard of Care Negative Pressure Wound Therapy (NPWT) | Device | Acellular Fish Skin, used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 9 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bounthavy Homsombath, MD | Joseph M.Still Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph M. Still Research Foundation | Augusta | Georgia | 30909 | United States |
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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.
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| Acellular Human Cadaver (AHC) with Standard of care Negative Pressure Wound Therapy (NPWT) | Other | Acellular Human Cadaver , used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take. |
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| ID | Term |
|---|---|
| D019115 | Fasciitis, Necrotizing |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
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