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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DeepView SnapShot Portable (DV-SSP) | Device | DV-SSP assistive imaging to collect observational data |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary BC Endpoint | Demonstrate the DeepView AI-Burns' sensitivity is superior to BC HCPs' bedside examination while maintaining non-inferior specificity to burn HCPs. | 3 weeks |
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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.
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Subjects enrolled in this study will be recruited at the designated Study Site within 72 hours of suffering a thermal burn injury. Adult and pediatric Subjects with burns from one or more of the defined burn severities will be enrolled. All Subjects must meet the specified inclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Valleywise Health | Phoenix | Arizona | 85008 | United States | ||
| Shriners Children's Northern California |
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| Sacramento |
| California |
| 95817 |
| United States |
| University of California Davis Health | Sacramento | California | 95817 | United States |
| University of California San Diego | San Diego | California | 92093 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66103 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| University Medical Center | New Orleans | Louisiana | 70112 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| SUNY Stony Brook Medical Center | Stony Brook | New York | 11794 | United States |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27514 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| St. Christopher's Children Hospital | Philadelphia | Pennsylvania | 19134 | United States |
| MUSC Shawn Jenkins Children's Hospital | Charelston | South Carolina | 29425 | United States |
| Texas Tech University | Lubbock | Texas | 79409 | United States |
| University of Utah Health | Salt Lake City | Utah | 84132 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | United States |
| University of Washington Harborview | Seattle | Washington | 98104 | United States |
| ID | Term |
|---|---|
| D002056 | Burns |
| D014947 | Wounds and Injuries |
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