Necrotizing Fasciitis
Conditions
Brief 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.
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.
Interventions
DEVICEAcellular Fish Skin Graft (AFS) 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.
OTHERAcellular Human Cadaver (AHC) with Standard of care Negative Pressure Wound Therapy (NPWT)
Acellular Human Cadaver , used to temporize a wound bed prior to autograft. The intention is to prepare the wound bed for optimal autograft take.
Sponsors
Joseph M. Still Research Foundation, Inc.
Kerecis Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint: To compare the time from first application of study product to time of autografting between the two study groups. | 9 weeks | To compare the time (number of days) from the first application of study product to time (number of days ) to autografting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoint: To compare the percentage of autograft take between the two study groups. | 9 weeks | To measure the percentage from 0 to 100% of autograft adherence to the wound bed |
Countries
United States
Outcome results
None listed