Burns, Wound Heal
Conditions
Brief summary
The purpose of this study is to continue development and validation of an algorithm for burn healing assessment by the Spectral MD DeepView device and provide burn healing potential assessment.
Interventions
DV-SSP assistive imaging to collect observational data
Sponsors
SpectralMD
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Willing and able to give informed consent or have a Legally Authorized Representative (LAR) able to do so; * Life expectancy \> 6 months; * Thermal burn mechanism (flame, scald, or contact); * The Study Burn(s) occurred less than 72 hours prior to the time of first imaging; and * Minimum burn wound size for adult or pediatric patients is 0.5% TBSA per region * For adult Subjects: Have 2 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn. * For pediatric Subjects: Have 1 - 4 regions of their clinical burn(s) that meet the criteria for a Study Burn
Exclusion criteria
* Burn pattern distribution isolated to head, face, neck, hands, feet, genitalia, and/or joints; * Subject has burns involving \> 50% total body surface area (TBSA); * Sepsis at the time of enrollment; * Immunosuppression/radiation/chemotherapy \< 3 months prior to enrollment; * Concurrent use of investigational products with a known effect on the burn sites; and/or * Any condition that in the opinion of the Investigator may prevent compliance with the study requirements or compromise subject safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predict area of severe burn, using measurement tools such as the Pearson Correlation Coefficient | 3 weeks | Test that the Burn Segmentation Algorithm's predicted severe burn area (i.e., deep second degree and third degree) within an image of a burn injury, will be equivalent to the true area of severe burn as determined by the expert panel. The analysis for this study would only include data obtained from participants in the study. |
Countries
United States
Outcome results
None listed