Burn Validation Study (BVS)

Spectral MD

Status

Completed

Conditions

Wound Heal

Burns

Wounds and Injuries

Treatments

Device: DeepView SnapShot Portable (DV-SSP)

Study type

Observational

Funder types

Industry

Identifiers

NCT06131203

CLA-PR-01

Details and patient eligibility

About

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.

Enrollment

274 patients

Sex

All

Volunteers

No Healthy Volunteers

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.