Burns Second Degree Clinical Trial
Official title:
Contribution of Thermal Imaging in Determining the Depth of Pediatric Acute Burns: a Prospective Observational Study
The need to cover a burn with a skin graft is determined primarily by its depth. In fact only
burns of the second deep degree or the third degree are likely to be grafted. However, if the
diagnosis is obvious in the case of third degree burns, second degree burns are often "mixed"
with more or less deep areas, especially in pediatrics.
Clinical experience and daily observation of the burn since its occurrence currently
determine the indication for surgery. In practice, it is rare to be able to determine with
certainty whether a second degree mixed burn will require a graft before the 10-12th day of
evolution. There are currently devices that can help refine the diagnosis such as laser
Doppler, but they are expensive devices, and not 100% reliable. The thermal camera Flir-one®
attaches to a smartphone or tablet and allows thanks to a free application, to obtain a
thermogram of the pointed area. This is a device used to detect insulation deficits in the
building sector. Knowing that a deep burn, by devascularization, will have an external
temperature lower than a superficial burn, a thermogram would thus make it possible to better
identify the deep zones and the superficial zones of the burn. One study showed a good
sensitivity and specificity of the device but it was a population of adult patients. This
determined that a difference in skin temperature between a deep burned area and healthy skin
should be at least 1.15 ° C in favor of healthy skin, to retain a burn as deep, and not to
operate so-called superficial burn if this difference was below this threshold. However,
further studies would be needed to demonstrate the validity of this method in clinical
practice.
All patients under 18, with acute burns (<10 days of development), surface area <10%, second
degree, hospitalized from 22/01/18 in the plastic surgery department and burns Trousseau
Hospital in Paris, subject to the non-opposition of parental authority. 500000 pediatric
burns are counted each year in France. In 2005, they resulted in 5109 hospital stays 2.
Improving the accuracy of the diagnosis before 10 days of evolution would make it possible to
graft the children who needed it more quickly and thus shorten the length of hospital stay.
It is therefore a public health issue, with a significant medical and economic impact.
Description of the item (s) being researched
It involves collecting, through a thermal camera, a temperature difference between a
second-degree burn zone and an adjacent healthy zone, in order to prove that this difference,
can make it possible to retain the burn as deep, and can therefore guide a surgical decision.
Justification of the duration of the research.
According to the same study in adults1, the number of patients to be included was 41 to
obtain sufficient power for a statistical analysis of the same data collected in this study,
and according to the same methodology. A duration of 4 months seems compatible with such
recruitment in the specialized center for treating pediatric burns at the Trousseau Hospital
in Paris.
Goal of the study: Objectively determine the depth of pediatric acute burns using a thermal
imaging camera.
METHOD AND POPULATION
Main evaluation criterion Measurement of Δ T = temperature difference between the burned area
and an adjacent healthy area of 3cm, or contralateral if extremity burns, with the thermal
camera, by a blind surgeon the final evaluation of the depth (between D10 and D14 ).
The thermograms will be read at three different times, from the moment of admission to
hospital or after the patient has been cured by:
- T1: D1 to D4 of the burn
- T2: D4 to D7 of the burn
- T3: D7 to D10 of the burn.
Secondary evaluation criteria Interest of the repeated measurements to determine if the
evolution of ΔT is also an index reflecting the depth of the burn.
Recruitment of the population Hospitalized patients from 22/01/18 in the Pediatric Burn
Surgery Department of Trousseau Hospital in Paris.
Eligibility criteria (inclusion and non-inclusion criteria) Inclusion criteria: All patients
<18 years of age, with acute burns (<10 days of progression) of the second degree of body
surface area burned <10%, hospitalized from 22/01/18 in the plastic surgery department and
burns at the Trousseau Hospital in Paris, subject to the non-opposition of parental
authority.
Criteria for non-inclusion: First-degree burns, third-degree burns, fever episode not caused
by burns, burn surgery before measurement, inability to communicate with the persons having
parental authority.
Population monitoring Patients will be followed as usual as part of the nurse consultation
consultation treatment every 2 days initially at the Trousseau Hospital Pediatric Burn
Treatment Center, with surgical advice on how to proceed with care. local, as was already the
case, then the pace will adapt to the pathology, with iterative appointments specialized
consultation with the surgeon from 15 days after discharge and every 2 months until complete
healing and definitive in the event of satisfactory evolution. In the case of surgery
necessary for healing during hospitalization, the follow-up may last for a period of 2 years.
Risks AND VIGILANCE
Non-interventional research involving the human person presents no risk to patients.
The adverse effects observed in the patients participating in the research are notified by
the investigators according to the local vigilance plans put in place as part of the care
activities.
Terms of data collection
The collection of thermograms on thermal camera is performed by a blind surgeon of the
operative decision of the burn. The thermograms will be read at three different times, from
the moment of admission to hospital or after the patient has been cured by:
- T1: D1 to D4 of the burn
- T2: D4 to D7 of the burn
- T3: D7 to D10 of the burn
An operative decision or a continuation of the surgical care is recorded in the database at
D10-14 in blind of the registered thermograms, by the only expertise of a surgeon different
from that having measured the ΔT thus without modification of the care usually dispensed for
each patient included.
The research does not foresee the use of data extracted from existing information systems or
study bases already carried out.
Data circuit The collection of thermograms on a thermal camera is done by a surgeon who uses
himself to transfer them by connectivity on the centralized computer database, protected,
anonymized with a number given to each patient which only the surgeon having collected the
thermograms knows the correspondence with the real identity. This surgeon does not
participate in the operative decision of the patient and records it if necessary in the
patient database after it is taken by the rest of the surgical team who remains blind
thermograms and Δ T measured.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04890574 -
CellMist™ Autologous Cells to Treat Deep Second-Degree Burns
|
Phase 1 |