Utilizing 3D Imaging for Burn Wound Assessment

NCT06938061 | Recruiting FDA Device

• 1 other identifier: A24-362
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

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

Keywords

3D Imaging; AI

Outcome Measures

Primary Outcomes (1)

• Concordance between TBSA based on Clinician measurements and TBSA based on DermaMonitor Camera measurements

  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.

  Through study completion, an average of one year

Secondary Outcomes (1)

• 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

Study Arms (3)

1st Degree Burn

Patients presenting to Regions Hospital Burn Clinic with a 1st degree burn

Device: 3D Imaging

2nd Degree Burn

Patients presenting to Regions Hospital Burn Clinic with a 2nd degree burn

Device: 3D Imaging

3rd Degree Burn

Patients presenting to Regions Hospital Burn Clinic with a 3rd degree burn

Device: 3D Imaging

Interventions

3D Imaging DEVICE

The Derma Monitor device is a handheld, battery powered camera incorporating polarized LED illumination, a high-resolution CMOS color image sensor and a 3D depth sensor, allowing for the imaging and mapping of a patient's skin.

Also known as: DermaMonitor Camera

1st Degree Burn; 2nd Degree Burn; 3rd Degree Burn

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting outpatient to the Regions Hospital burn clinic after a burn

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital Burn Clinic

Saint Paul, Minnesota, 55101, United States

RECRUITING

Related Publications (2)

• Irwin LR, Reid CA, McLean NR. Burns in children: do casualty officers get it right? Injury. 1993 Mar;24(3):187-8. doi: 10.1016/0020-1383(93)90291-d.

  PMID: 8509192 BACKGROUND

• Ho HL, Halim AS, Sulaiman WAW, Fatimah MJ. Estimation of Total Body Surface Area Burned: A Comparison Between Burn Unit and Referring Facilities. Ann Burns Fire Disasters. 2023 Mar 31;36(1):19-28. eCollection 2023 Mar.

  PMID: 38680901 BACKGROUND

MeSH Terms

Conditions

Burns

Interventions

Imaging, Three-Dimensional

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 22, 2025
• Study Start: May 20, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)