Burn, Burn Injury
Conditions
Keywords
SFDI, Spatial Frequency Domain Imaging, Burn depth, Burn injury assessment
Brief summary
The goal of this pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. SFDI has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. The two feasibility goals of this study are as follows: 1) Do the values obtained with a commercial SFDI system provide utility in assessing burn depth in a clinical setting? And 2) Do Clarifi and m-Clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).
Interventions
DIAGNOSTIC_TESTSpatial Frequency Domain Imaging
Spatial Frequency Domain Imaging captures at specific timepoints.
Sponsors
The United States Institute of Surgical Research
Modulated Imaging Inc.
The Metis Foundation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 18 years of age or older 2. Thermal burns of any depth (superficial, deep partial thickness, or full thickness).
Exclusion criteria
1. Patients less than 18 years of age 2. Pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems | From enrollment to 21 days | This outcome will report the mean value of the scattering coefficient (μs'), a quantitative SFDI-derived biomarker that correlates with burn depth, measured at specified time points (Day 0, 3, 7, 14, and 21) using the Clarifi and m-Clarifi imaging systems. Higher scattering values are associated with deeper tissue damage. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation Between SFDI Scattering Parameter and Clinician-Determined Burn Depth | From enrollment to 21 days | This outcome evaluates the statistical correlation between SFDI scattering values and the burn depth classifications made by clinicians based on visual assessment and standard clinical criteria (e.g., superficial partial, deep partial, full thickness). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Clarifi and m-Clarifi Devices in Measuring SFDI Scattering Parameter | From enrollment to 21 days | This outcome assesses the agreement between SFDI scattering measurements obtained from the Clarifi (FDA-cleared) and m-Clarifi (handheld prototype) devices at the same anatomical burn sites. Agreement will be quantified using Bland-Altman analysis and intraclass correlation coefficients (ICCs). |
Countries
United States
Contacts
Primary ContactVictoria Diaz, BSN
Outcome results
None listed