Clinical trial NCT06073301: AFS Compared to AHC in Treatment of Necrotizing Fasciitis NF
Official title: Comparison of Treatment with Acellular Fish Skin (AFS) to Acellular Human Cadaver Allograft (AHC) in the Treatment of Necrotizing Fasciitis (NF)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Necrotizing Fasciitis
Lead sponsor: Kerecis Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Joseph M. Still Research Foundation, Inc.
First posted: 2023-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary endpoint: To compare the time from first application of study product to time of autografting between the two study groups.
timeFrame: 9 weeks
Secondary outcomes:
measure: Secondary Endpoint: To compare the percentage of autograft take between the two study groups.
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Joseph M. Still Research Foundation
state: Georgia
Study officials:
affiliation: Joseph M.Still Research Foundation
name: Bounthavy Homsombath, MD
role: PRINCIPAL_INVESTIGATOR
References: