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Not yet recruiting NCT06921421

Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging

— Observational Burn Burn Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spatial Frequency Domain Imaging.
Who it may be relevant to
Registry conditions: Burn, Burn Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Assessment Of Burn Severity and Extent Spatial Frequency Domain Imaging (SFDI): An Observational Pilot Study

Overview

The goal of this pilot clinical study is to evaluate the feasibility of collecting Spatial Frequency Domain Imaging (SFDI) data in patients with circulatory compromise due to thermal burns using the FDA-cleared Clarifi Imaging System and the next generation handheld m-Clarifi. Accurate assessment of burn depth and assessment at the point of care is an essential input for clinicians to plan proper treatment and management. SFDI has been shown to be a promising method to evaluate burn depth and extent within 24 hours in pre-clinical studies. The two feasibility goals of this study are as follows: 1) Do the values obtained with a commercial SFDI system provide utility in assessing burn depth in a clinical setting? And 2) Do Clarifi and m-Clarifi provide equivalent data when assessing subjects with burn injuries (biomarker imaging values, clinical workflow).

Interventions

  • Diagnostic test Spatial Frequency Domain Imaging
    Spatial Frequency Domain Imaging captures at specific timepoints.

Primary outcome measures

  • Mean SFDI Scattering Parameter (mm-¹) at Burn Injury Sites Using Clarifi and m-Clarifi Imaging Systems [Time frame: From enrollment to 21 days]
Secondary outcome measures (1)
  • Correlation Between SFDI Scattering Parameter and Clinician-Determined Burn Depth [Time frame: From enrollment to 21 days]

Eligibility criteria

Inclusion criteria

  • Patients 18 years of age or older
  • Thermal burns of any depth (superficial, deep partial thickness, or full thickness).

Exclusion criteria

  • Patients less than 18 years of age
  • Pregnant or breastfeeding women

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The United States Army Institute of Surgical Resarch — Fort Sam Houston

Identifiers

NCT: NCT06921421 · H-25-017 · MTEC-22-08-BDA-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗