Burns Second DegreeFLIRPEDNCT03702972
Thermal Imaging and Pediatric Burns
An observational study of Burns Second Degree, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Burns Second Degree
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Jan 2019
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Minor patients hospitalized in the Burns Surgery Department at Trousseau Hospital with second degree burns less than 10 days old, less than 10% of total body surface area
Who may be able to join
- Age <18 years,
- Acute burns (<10 days of evolution) of the second degree
- Body surface burned <10% of total body area
- Hospitalized patients for a period of 4 months and 15 days in the plastic surgery and burns department at Trousseau Hospital in Paris.
- Affiliates to the general system of social security as having the right of the holders of parental authority
Who cannot join
- Burns of the first degree,
- Third degree burns,
- fever episode not caused by burning,
- Surgical procedure on burn before measurement,
- Impossibility to communicate with the holders of the parental authority or opposition formulated to the participation
About this study
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.
Read the detailed description
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.
- Conditions
- Burns Second Degree
- Keywords
- Burn, Pediatry, Flir One Thermal Imager, Depth determination
- Medical subject headings
- Burns
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature difference between burned zone and adjacent or contralateral healthy zone at time T3
Δ T3 will be recorded from day 7 to day 10 once by the Flir One Thermal Imager
Measured: day 7 to day 10 from the day of the burn occurrence
Secondary outcomes (2)
Temperature difference between burned zone and adjacent or contralateral healthy zone at time s T1
Δ T1 will be recorded from day 1 to day 4 once by the Flir One Thermal Imager
Measured: day 1 to day 4 from the day of the burn occurrence
Temperature difference between burned zone and adjacent or contralateral healthy zone at time s T2
Δ T2 will be recorded from day 4 to day 7 once by the Flir One Thermal Imager
Measured: day 4 to day 7 from the day of the burn occurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Why it stopped: Essential equipment unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burns Second DegreeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie CASSIER, Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702972
- Sponsor's protocol ID
- NI18021J
- Other IDs
- 2018-A01154-51
- Acronym
- FLIRPED
- Status last verified
- Aug 2018
- First submitted
- 28 Sep 2018
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Thermal Imaging in Determining the Depth of Pediatric Acute Burns: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03702972
- Acronym / sponsor ID
- FLIRPED / NI18021J
- Conditions
- Burns Second Degree
- Keywords
- Burn, Pediatry, Flir One Thermal Imager, Depth determination
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Essential equipment unavailable
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Minor patients hospitalized in the Burns Surgery Department at Trousseau Hospital with second degree burns less than 10 days old, less than 10% of total body surface area
Key inclusion criteria (5 listed)
- Age <18 years,
- Acute burns (<10 days of evolution) of the second degree
- Body surface burned <10% of total body area
- Hospitalized patients for a period of 4 months and 15 days in the plastic surgery and burns department at Trousseau Hospital in Paris.
- Affiliates to the general system of social security as having the right of the holders of parental authority
Key exclusion criteria (5 listed)
- Burns of the first degree,
- Third degree burns,
- fever episode not caused by burning,
- Surgical procedure on burn before measurement,
- Impossibility to communicate with the holders of the parental authority or opposition formulated to the participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Temperature difference between burned zone and adjacent or contralateral healthy zone at time T3
Time frame: day 7 to day 10 from the day of the burn occurrence
Δ T3 will be recorded from day 7 to day 10 once by the Flir One Thermal Imager
2 secondary outcomes
Temperature difference between burned zone and adjacent or contralateral healthy zone at time s T1
Time frame: day 1 to day 4 from the day of the burn occurrence
Temperature difference between burned zone and adjacent or contralateral healthy zone at time s T2
Time frame: day 4 to day 7 from the day of the burn occurrence
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Burns Second Degree
Not yet recruiting
Impact of Range of Motion Exercises on Pain and Functional Ability
Impact of ROM Exercises on Pain and Functional Ability in Patients With Second -Degree Burns
Not yet recruitingObservational study
Phoenixin and Pain in Pediatric Burn Patients
Children, Acute Pain
Not yet recruitingObservational study
The Use of Cultured (Dermal) Epithelial Autografts in Severely Burned Patients
Burn Degree Second, Burn Degree Third
Not yet recruiting
Development and Clinical Study of Burn Wound Nursing Dressing Based on Sodium Hyaluronate Carbomer Composite Hydrogel
Burn, Burn Contracture of Skin
Not yet recruitingObservational study
Cell Suspension With Biologic Dressing for Burn Wounds
Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophie CASSIER, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
An observational study of Burns Second Degree, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Temperature difference between burned zone and adjacent or contralateral healthy zone at time T3 (time frame: day 7 to day 10 from the day of the burn occurrence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.