Utilizing 3D Imaging for Burn Wound Assessment

Recruiting

• Conditions: Burn; 2nd Degree Burn of the Skin; 3rd Degree Burn of the Skin; 1st Degree Burn of the Skin

• Registration Number: NCT06938061
• Lead Sponsor: HealthPartners Institute

Brief Summary

The goal of this prospective cohort study is to determine if the DermaMonitor camera can accurately determine burn size in patients with 1st, 2nd, or 3rd degree burns, with exploratory aim of testing a new Artificial Intelligence (AI) program for determining burn depth. The main aims are:

1. The primary aim of this study is to assess an objective process for the classification of burn size using the DermaMonitor wound camera.

2. An exploratory aim of this study is to begin to train an Artificial Intelligence (AI) program to classify burn depth (1st, 2nd, 3rd degree) using the 3D images from this novel wound camera.

Researchers will compare DermaMonitor size classification and AI depth classification to clinician determinations. Participants will have images taken of their burn. Participation ends when the images are taken.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-31
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-22
• Status Verified: 2025-05
• Study Start: 2025-05-20
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-28
• Primary Completion: 2026-05
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

• Adults sustaining burns
• Outpatients
• No prior surgery on the wounds
• No known infection of the wounds

Exclusion Criteria

• Burns to the face or sensitive areas (genitals)
• Burns located on or near identifying landmarks such as tattoos or birthmarks
• Non-English speaking patients
• Patients unable to sign their name
• Burn occurred greater than 7 days prior to clinic visit
• Age greater than 90 (Patient age is sent externally to IKO, to ensure no PHI is sent, patients with an age >90 will not be enrolled)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Concordance between TBSA based on Clinician measurements and TBSA based on DermaMonitor Camera measurements	Through study completion, an average of one year	Measurements of the burn will be taken by clinicians in the burn clinic and translated into total burn surface area (TBSA) using body mass index and height. This will be compared to TBSA computed from measurements taken virtually using the DermaMonitor camera and the same body mass index and height values.

Secondary Outcome Measures

Name	Time	Method
Concordance between clinician burn depth determination (1st, 2nd, 3rd degree burn) and AI determination of burn depth based on DermaMonitor images	Through study completion, an average of one year	Clinicians will subjectively determine burn depth (1st, 2nd, or 3rd degree) based on physical exam and clinical factors. This will be compared to burn depth assessment (1st, 2nd, or 3rd degree) made by an Artificial Intelligence program using the 3D images from the DermaMonitor camera.

Trial Locations

Locations (1)

Regions Hospital Burn Clinic; 🇺🇸 Saint Paul, Minnesota, United States