Utilizing 3D Imaging for Burn Wound Assessment

NCT ID: NCT06938061

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-20

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1st Degree Burn

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

3D Imaging

Intervention Type 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.

2nd Degree Burn

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

3D Imaging

Intervention Type 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.

3rd Degree Burn

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

3D Imaging

Intervention Type 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.

Interventions

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3D Imaging

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.

Intervention Type DEVICE

Other Intervention Names

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DermaMonitor Camera

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HealthPartners Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Regions Hospital Burn Clinic

Saint Paul, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Nicholas Larson

Role: primary

651-254-4846

References

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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.

Reference Type BACKGROUND
PMID: 8509192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38680901 (View on PubMed)

Other Identifiers

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A24-362

Identifier Type: -

Identifier Source: org_study_id

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