Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05167461 |
| Other study ID # |
12689 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 24, 2022 |
| Est. completion date |
May 25, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Indiana University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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 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.
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.
