Utilizing 3D Imaging for Burn Wound Assessment (NCT06938061) | Clinical Trial Compass
TerminatedNot Applicable
Utilizing 3D Imaging for Burn Wound Assessment
Stopped: Stopped due to feasibility concerns with enrollment
United States8 participantsStarted 2025-05-20
Plain-language 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.
Who can participate
Age range
18 Years – 89 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concordance between TBSA based on Clinician measurements and TBSA based on DermaMonitor Camera measurements
Timeframe: Through study completion, an average of one year