Burn Validation Study

Completed

Conditions studied: Burns, Wound Heal, Wounds and Injuries

In brief

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.

Key facts

Study ID

NCT06131203

Run by

SpectralMD

People needed

274

Starts

2023-12-19

Expected to finish

2025-04-01

Last updated by the study team

2025-04-25

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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.

Where it is running

• Valleywise Health — Phoenix, Arizona, United States
• Shriners Children's Northern California — Sacramento, California, United States
• University of California Davis Health — Sacramento, California, United States
• University of California San Diego — San Diego, California, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Tampa General Hospital — Tampa, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• University Medical Center — New Orleans, Louisiana, United States
• University of Rochester — Rochester, New York, United States
• SUNY Stony Brook Medical Center — Stony Brook, New York, United States
• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• St. Christopher's Children Hospital — Philadelphia, Pennsylvania, United States
• MUSC Shawn Jenkins Children's Hospital — Charelston, South Carolina, United States
• Texas Tech University — Lubbock, Texas, United States
• University of Utah Health — Salt Lake City, Utah, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• University of Washington Harborview — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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