Burn Pivotal Study
Purpose
The purpose of this study is to validate the algorithm for burn healing assessment by the Spectral MD DeepView device which would provide burn healing potential assessment.
Conditions
- Burns
- Wound Heal
- Wounds and Injuries
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts 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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Emergency Department Burn Subjects | Subjects with Thermal Burn Injury enrolled through the emergency department |
|
Burn Center Burn Subjects | Subjects with Thermal Burn Injury enrolled through the burn center |
|
Recruiting Locations
Washington, District of Columbia 20010
More Details
- Status
- Recruiting
- Sponsor
- SpectralMD