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Burns MultipleAMBUSHNCT05167461

AutoMated BUrn Diagnostic System for Healthcare (AMBUSH)

An observational study of Burns Multiple and Burns, run by Indiana University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to develop a high accuracy and automated system that can provide early assessment of burn injuries with at least 90% accuracy in absence of burn experts, using AI and FDA cleared harmonic ultrasound TDI data based on the analysis of mechanical and hemodynamic properties of the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Burns Multiple, Burns, Thermal Burn
What is being tested?
Collection of imaging by ultrasonography
How many people
30 participants
Where
1 siteUnited States
Study dates
24 May 2022to 25 May 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects aged 18 years and above, male and female, with a thermal burn injury will be considered for participation in this study. Enrollment of 30 subjects is planned

Subjects must meet all the following enrollment criteria to be eligible for participation in the study:

  1. Male or female patients aged 18 years and above.
  2. The patient has a thermal burn injury
  3. Antibiotic use allowed
  4. Patient does not need to have the ability to communicate
  5. Inpatient or outpatient
  6. Within 7 days of burn
  7. No prior surgical debridement
  8. Burn ≤ 75% of body surface
  9. The patient or their legal representative agrees to comply with all compulsory study procedures and visit schedule
  10. The patient or their legal representative agrees to abstain from enrollment in any other clinical trial for the duration of the study.
  11. In the opinion of the investigator, the patient or their legal representative must be able to:
  12. Understand the full nature and purpose of the study, including possible risks and adverse events,
  13. Understand instruction, and
  14. Provide voluntary informed written consent/assent as appropriate for study participation.

Exclusion Criteria: Subjects who meet any of the following criteria are not eligible for participation in the study:

  1. Unable to provide informed consent
  2. Age <18 years
  3. Burn ≥ 75% of body surface
  4. Burns caused by chemicals, electricity or radiation.
  5. Patients presenting with only 3rd-degree/full-thickness wounds which require immediate autografting.
  6. Burn injury has had prior surgical treatment.
  7. Prisoners
  8. Pregnant individuals
  9. Unable to follow study schedule or understand study instructions

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Eskenazi Health

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Official title: AutoMated Burn Diagnostic System for Healthcare

The primary objective of this study is to develop a high accuracy and automated system that can provide early assessment of burn injuries with at least 90% accuracy in absence of burn experts, using AI and FDA cleared harmonic ultrasound TDI data based on the analysis of mechanical and hemodynamic properties of the subcutaneous burned tissue. Data collected in this study will lead to the development of better diagnostic tools that could inform clinical burn practices by enabling doctors to determine burn depth and the need for surgery with greater speed and accuracy, resulting in better clinical outcomes.

Read the detailed description

Burn injuries are considered as one of the most complex type of traumatic injuries. In the United States (US), about 1.25 million people are treated each year for burns, and 40,000 are hospitalized for the treatment of these injuries resulting in high medical costs, approximately $7.9 billion per year. Early and accurate treatment of burns is critical to prevent infections and improve the possible outcomes of the patient, decreasing the mortality rate by about 36% In this regard, prioritizing burns that require a surgical procedure to heal, i.e. burn excision and skin grafting, is critical. This constitutes a challenging task because it involves the determination of the burn depth, for which experienced burn surgeons achieve an accuracy of 67-76%, value that decreases to 50% for inexperienced surgeons. Assessment of the burn depth is one of the most important aspects of burn care. It is a predictor of pathological scarring that occurs in 30%-91% of burn injuries. However, it continues to be an open clinical challenge for which an accurate solution has yet to be found. Burns are classified into three different categories: superficial burns, which involve only epidermis; partial-thickness burns, which affect epidermis and dermis; and full-thickness burns, which include deep structures such as subcutaneous, muscles, and bone. The first two are expected to heal without scarring by 14-21 days after the burn injury, while the last one will heal with scarring resulting in significant morbidity to the patient, including pain, loss of joint mobility, loss of function, and social isolation. For this reason, full-thickness burns are excised, and exposed body parts are covered with skin grafts to prevent further complications with scarring Currently, burn depth is determined by clinical assessment, based on appearance, blanching to pressure, sensation to pin prick, and bleeding on needle prick. This visual and tactile inspection approach introduces inter-subject variability, especially when partial-thickness burns are involved. Overestimation of burn depth leads to unnecessary surgery of excision of viable skin and replacement with skin grafts that look different from surrounding skin. These grafts are less pliable with lack of the ability to sweat for thermoregulation, while underestimation leads to surgical delay, long length of hospital stays, high treatment costs, scarring, and poor functional and aesthetic outcomes. This issue is exacerbated by a phenomenon known as burn conversion, which is not fully understood yet, and it is usually not accounted for in the assessment process or in the clinical decision support technologies. Burn injury is a dynamic process, the longer the delay in intervening, the more abundant the scar tissue formation and the more likely the patient is to have deformity with loss of mobility and function. Thus, early prediction of burn conversion is critical for surgical decision making and burn follow up. Several non-invasive light-based imaging technologies have been developed to support clinical assessment, which is currently the most common technique for burn depth assessment. They operate based on the existing correlation among blood perfusion, functional blood vessels, and burn depth. However, Laser Doppler Imaging (LDI) is the only one approved by FDA. It is the most widely adopted non-invasive technology in burn treatment facilities in the US, but it is used as the preferred modality in only 6% of them. Considering the many limitations of this technology, this is not unexpected. It uses light/optic principles to detect the active blood flow in the damaged tissue of the patient, and the results can be greatly altered by the curvature of tissues, ambient light and temperature, motion artifacts, topical wound dressings, non-debrided tissue, skin color, pigment from tattoos, and blisters. In addition, LDI performance is poor when burn injuries are less than 24 hours old and can be difficult to interpret for inexperienced users. To overcome the limitations of light-based technologies, the investigators will integrate novel techniques in Artificial Intelligence (AI), Computer Vision, with FDA approved Harmonic B-mode ultrasound (HUSD B-mode) and Harmonic Ultrasound Tissue Doppler Elastography imaging (TDI), medical expertise in the wound care, tissue injury management, and burn surgery domains. This will enhance the burn assessment accuracy, improving the patient's prognosis.

Being tested
Collection of imaging by ultrasonography
Keywords
burns, thermal burn
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of imaging by ultrasonographyOther

    Also called deep machine learning

    The investigators will collect burn image data to be processed through the software combined with the deep machine learning to find automated diagnostic burn assessment with accuracy of >95% compared to human assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare human assessment of burn depth to AI assessment

    Compare human assessment of burn depth to the technology output (Artificial Intelligence and TDI) as determined by need for surgery (time points include day 0 +/- 3 days). Biopsy collected from patients that go to OR (one-time collection) to verify the burn depth via histological analysis.

    Measured: 2 year

Secondary outcomes (1)
  1. Confirm burn conversion

    : Confirm burn conversion by the presence of infection as found in the electronic medical record (EMR). Confirm burn infection by sending one tissue biopsy from OR (one-time collection)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2021
  2. Study start24 May 2022
  3. Primary completion25 May 2023
  4. Study completion25 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05167461
Sponsor's protocol ID
12689
Acronym
AMBUSH
Status last verified
Oct 2023
First submitted
5 Nov 2021
Last updated
23 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share the artificial intelligence data regarding how the AI performed in comparison to the human evaluators

Publications

  • Rahman MM, Masry ME, Gnyawali SC, Xue Y, Gordillo G, Wachs JP. AI-Driven Integrated System for Burn Depth Prediction With Electronic Medical Records: Algorithm Development and Validation. JMIR Med Inform. 2025 Aug 15;13:e68366. doi: 10.2196/68366.

    PubMed 40815778

Questions about this trial

What is this clinical trial studying?

An observational study of Burns Multiple and Burns, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare human assessment of burn depth to AI assessment (time frame: 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05167461, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.

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