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

ArmDescriptionAssigned Intervention
Emergency Department Burn Subjects Subjects with Thermal Burn Injury enrolled through the emergency department
  • Device: DeepView SnapShot Portable (DV-SSP)
    DV-SSP assistive imaging to collect observational data
Burn Center Burn Subjects Subjects with Thermal Burn Injury enrolled through the burn center
  • Device: DeepView SnapShot Portable (DV-SSP)
    DV-SSP assistive imaging to collect observational data

Recruiting Locations

MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Melissa McLawhorn
Melissa.M.McLawhorn@medstar.net

More Details

Status
Recruiting
Sponsor
SpectralMD

Study Contact

Alex Krajcevska
(972) 499-4934
regan@spectralmd.com