Summary

Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Kathleen Romanowski, MD (ucdavis)

Description

Summary

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.

Official Title

Performance Evaluation of the DeepView AI-Burn For Assessment of Thermal Burn Healing Potential

Keywords

Burns, Wound Heal, Wounds and Injuries, DeepView SnapShot Portable (DV-SSP)

Eligibility

You can join if…

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

You CAN'T join if...

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.

Locations

  • University of California Davis Health accepting new patients
    Sacramento California 95817 United States
  • Shriners Children's Northern California accepting new patients
    Sacramento California 95817 United States

Lead Scientist at University of California Health

  • Kathleen Romanowski, MD (ucdavis)
    Assistant Professor, Surgery, School of Medicine. Authored (or co-authored) 61 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SpectralMD
ID
NCT06131203
Study Type
Observational
Participants
Expecting 240 study participants
Last Updated