BurnsNCT03876340
Impact of a Clinical Decision Algorithm on Length of Hospital Stay and Costs of Care of Burned Patients
A study testing Treatment algorithm and Current treatment in people with Burns, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.
Trial summary
Reliable and valid assessment of burn wound depth or healing potential is essential to treatment decision-making, to provide a prognosis, and to compare studies evaluating different treatment modalities. Clinical evaluation remains the most widely used method for assessing the depth of the burn wound. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Burns
- What is being tested?
- Treatment algorithm and Current treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteMexico
- Study dates
- 1 Nov 2018to 31 Aug 2020
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with partial or full thickness burn in <15% of the total body surface area in distal limbs, including hands or feet.
- Patients admitted to the burn care unit within 24 hours from injury.
- Patients that signed the informed consent. In the case of children or patients unable to consent themselves, signing of the consent by their guardian.
Who cannot join
- Patients who sustained electrical burns.
- Patients that received previous care in any other unit.
- Patients with uncontrolled chronic diseases.
- Patients that used corticosteroids or cytotoxic medications within 3 months of sustaining the injury.
- Patients with a baseline body mass index of <19.9 for adults or below the 5th percentile for their age in children.
- Presence of foreign bodies embedded in the wound tissue, gross edema, systemic causes of distal hypoperfusion, or presence of local infection.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central Dr. Ignacio Morones Prieto
San Luis Potosí City, 78290
About this study
Official title: Impact of a Clinical Decision Algorithm on Length of Hospital Stay and Costs of Care of Burned Patients: a Pragmatic Clinical Trial
Reliable and valid assessment of burn wound depth or healing potential is essential to treatment decision-making, to provide a prognosis, and to compare studies evaluating different treatment modalities. Clinical evaluation remains the most widely used method for assessing the depth of the burn wound. This method is based on the subjective evaluation of visual and tactile characteristics of the wound, with an accuracy ranging between 50 to 70%; which is not precise to guide clinical decision making. The aim of these study is to validate thermography as a therapeutic approach to predict treatment modality based on thermographic imaging of the wound and its healing potential obtained during the first three days of treatment of either healing by re-epithelization, requiring skin grafts, or requiring amputations. By performing this algorithm, it is expected to address three aspects of the management of patients with acute burns: early clinical diagnosis, initial management decisions and reduction of hospitalization days.
Read the detailed description
Burn wounds are divided into first degree burns involving the epidermis, superficial second degree with lesion of the papillary dermis, deep second degree with lesion of the reticular dermis, third degree with lesion to the hypodermis, and fourth degree involves fascia, muscle, tendons and bone.
In burns, development and severity of complications are in direct proportion to the magnitude of the burn. The magnitude of the damage depends on three factors, the duration of the contact, the intensity of the current or temperature and the resistance offered by the tissue. The extent of the burned skin surface is very useful to assess the severity of the patient, it is a relevant criterion to develop the prognosis. It is important to have comprehensive knowledge of the burned patient and close collaboration with the multidisciplinary care team through a careful evaluation that includes mechanism of injury, type, extent, degree of affectation and organic repercussion of the burn. The reliable and valid evaluation on the depth of a burn wound or the healing potential is essential for the decision making in the treatment; to provide a prognosis and to compare the different treatment modalities. There is no gold standard in the evaluation of burns.
Infrared imaging is a non-invasive technique that quantifies the temperature of the body surface by capturing the thermal radiation emitted and producing a high-resolution digital image called a thermogram. The presence of a disease interferes locally with the heat balance, which results in an increase or decrease in the temperature of the skin, in comparison to the surrounding regions or the contralateral not affected region. A degree of thermal asymmetry between opposite sides of the body (ΔT) of up to 1 ° C has been considered indicative of dysfunction. In several previous studies the parameters of initial thermography between the wound and healthy skin (delta T) were defined, to decide the therapeutic approach of the burns to predict the evolution: ΔT <3º C epithelialized with conservative treatment, ΔT 3-5º C should be graft early and ΔT> 5º C should be amputated.Thermography offers a feasible option for valuation.
Methods:
This is randomized clinical study of patients with different burn depth. All patients will be examined using a thermal camera.
Expected Results:
In all cases, the investigators obtained infrared images that corroborate clinical findings.
- Conditions
- Burns
- Being tested
- Treatment algorithm, Current treatment
- Keywords
- Burns, Cost-effectiveness, Clinical decision rule, Length of stay, Cost of treatment
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment algorithmOther
Digital infrared thermograms will be obtained during the first contact with the patients. Temperature recordings of the injured and healthy skin will be used to calculate the temperature difference between the structures. The thermograms will be used to dictate the initial treatment.
Current treatmentOther
Digital infrared thermograms will be obtained during the first contact with the patients. Temperature recordings of the injured and healthy skin will be used to calculate the temperature difference between the structures, but the results will be kept sealed until the study is finished. The patients will receive the usual standard of care as dictated by the surgical team.
| Study group | Role | What they receive |
|---|---|---|
| Current treatment | Active comparator | Patients will receive burn care treatment as dictated by the surgical team (current standard of care). Receives: Other: Current treatment |
| Algorithm-dictated treatment | Experimental | Patients will receive burn care treatment as dictated by the treatment algorithm (PLOS ONE 13(11): e0206477.). Receives: Other: Treatment algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Number of days the patient stays in the burn care unit
Measured: Through study completion, an average of 30 days
Treatment modality conversion
Change of the initial treatment modality
Measured: Through study completion, an average of 30 days
Secondary outcomes (2)
Rate of complications
Presence of complications such as tissue necrosis, infection, death.
Measured: Through study completion, an average of 30 days
Cost of stay
Total cost of the stay in the burn care unit in american dollars (USD)
Measured: Through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2019
- Study start1 Nov 2018
- Primary completion31 Dec 2019
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BurnsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms: group A will receive treatment as usual, group B will receive treatment as dictated by a clinical decision algorithm (PLoS ONE 2018:13(11):e0206477).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIO AURELIO MARTÍNEZ-JIMÉNEZ, Hospital Central "Dr. Ignacio Morones Prieto"
- Investigators
- Jose L Ramirez Garcia Luna, MD, MSc, Study chair, Universidad Autonoma de San Luis Potosi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03876340
- Sponsor's protocol ID
- QX2018
- Status last verified
- Feb 2020
- First submitted
- 1 Mar 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez-Jimenez MA, Ramirez-GarciaLuna JL, Kolosovas-Machuca ES, Drager J, Gonzalez FJ. Development and validation of an algorithm to predict the treatment modality of burn wounds using thermographic scans: Prospective cohort study. PLoS One. 2018 Nov 14;13(11):e0206477. doi: 10.1371/journal.pone.0206477. eCollection 2018.
PubMed 30427892Medina-Preciado JD, Kolosovas-Machuca ES, Velez-Gomez E, Miranda-Altamirano A, Gonzalez FJ. Noninvasive determination of burn depth in children by digital infrared thermal imaging. J Biomed Opt. 2013 Jun;18(6):061204. doi: 10.1117/1.JBO.18.6.061204.
PubMed 23111601Kolosovas-Machuca ES, Gonzalez FJ. Distribution of skin temperature in Mexican children. Skin Res Technol. 2011 Aug;17(3):326-31. doi: 10.1111/j.1600-0846.2011.00501.x. Epub 2011 Feb 22.
PubMed 21338404
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Clinical Decision Algorithm on Length of Hospital Stay and Costs of Care of Burned Patients: a Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT03876340
- Acronym / sponsor ID
- QX2018
- Conditions
- Burns
- Keywords
- Burns, Cost-effectiveness, Clinical decision rule, Length of stay, Cost of treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Hospital Central "Dr. Ignacio Morones Prieto"University, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 15 Mar 2019 (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.
Reliable and valid assessment of burn wound depth or healing potential is essential to treatment decision-making, to provide a prognosis, and to compare studies evaluating different treatment modalities. Clinical evaluation remains the most widely used method for assessing the depth of the burn wound. This method is based on the subjective evaluation of visual and tactile characteristics of the wound, with an accuracy ranging between 50 to 70%; which is not precise to guide clinical decision making. The aim of these study is to validate thermography as a therapeutic approach to predict treatment modality based on thermographic imaging of the wound and its healing potential obtained during the first three days of treatment of either healing by re-epithelization, requiring skin grafts, or requiring amputations. By performing this algorithm, it is expected to address three aspects of the management of patients with acute burns: early clinical diagnosis, initial management decisions and reduction of hospitalization days.
Detailed description
Burn wounds are divided into first degree burns involving the epidermis, superficial second degree with lesion of the papillary dermis, deep second degree with lesion of the reticular dermis, third degree with lesion to the hypodermis, and fourth degree involves fascia, muscle, tendons and bone.
In burns, development and severity of complications are in direct proportion to the magnitude of the burn. The magnitude of the damage depends on three factors, the duration of the contact, the intensity of the current or temperature and the resistance offered by the tissue. The extent of the burned skin surface is very useful to assess the severity of the patient, it is a relevant criterion to develop the prognosis. It is important to have comprehensive knowledge of the burned patient and close collaboration with the multidisciplinary care team through a careful evaluation that includes mechanism of injury, type, extent, degree of affectation and organic repercussion of the burn. The reliable and valid evaluation on the depth of a burn wound or the healing potential is essential for the decision making in the treatment; to provide a prognosis and to compare the different treatment modalities. There is no gold standard in the evaluation of burns.
Infrared imaging is a non-invasive technique that quantifies the temperature of the body surface by capturing the thermal radiation emitted and producing a high-resolution digital image called a thermogram. The presence of a disease interferes locally with the heat balance, which results in an increase or decrease in the temperature of the skin, in comparison to the surrounding regions or the contralateral not affected region. A degree of thermal asymmetry between opposite sides of the body (ΔT) of up to 1 ° C has been considered indicative of dysfunction. In several previous studies the parameters of initial thermography between the wound and healthy skin (delta T) were defined, to decide the therapeutic approach of the burns to predict the evolution: ΔT <3º C epithelialized with conservative treatment, ΔT 3-5º C should be graft early and ΔT> 5º C should be amputated.Thermography offers a feasible option for valuation.
Methods:
This is randomized clinical study of patients with different burn depth. All patients will be examined using a thermal camera.
Expected Results:
In all cases, the investigators obtained infrared images that corroborate clinical findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two parallel arms: group A will receive treatment as usual, group B will receive treatment as dictated by a clinical decision algorithm (PLoS ONE 2018:13(11):e0206477).
| Arm | Type | Receives |
|---|---|---|
| Current treatment | Active comparator | Other: Current treatmentPatients will receive burn care treatment as dictated by the surgical team (current standard of care). |
| Algorithm-dictated treatment | Experimental | Other: Treatment algorithmPatients will receive burn care treatment as dictated by the treatment algorithm (PLOS ONE 13(11): e0206477.). |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with partial or full thickness burn in <15% of the total body surface area in distal limbs, including hands or feet.
- Patients admitted to the burn care unit within 24 hours from injury.
- Patients that signed the informed consent. In the case of children or patients unable to consent themselves, signing of the consent by their guardian.
Key exclusion criteria (6 listed)
- Patients who sustained electrical burns.
- Patients that received previous care in any other unit.
- Patients with uncontrolled chronic diseases.
- Patients that used corticosteroids or cytotoxic medications within 3 months of sustaining the injury.
- Patients with a baseline body mass index of <19.9 for adults or below the 5th percentile for their age in children.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment algorithmDigital infrared thermograms will be obtained during the first contact with the patients. Temperature recordings of the injured and healthy skin will be used to calculate the temperature difference between the structures. The thermograms will be used to dictate the initial treatment. | Other | Algorithm-dictated treatment |
| Current treatmentDigital infrared thermograms will be obtained during the first contact with the patients. Temperature recordings of the injured and healthy skin will be used to calculate the temperature difference between the structures, but the results will be kept sealed until the study is finished. The patients will receive the usual standard of care as dictated by the surgical team. | Other | Current treatment |
Primary outcome
Length of stay
Time frame: Through study completion, an average of 30 days
Number of days the patient stays in the burn care unit
Treatment modality conversion
Time frame: Through study completion, an average of 30 days
Change of the initial treatment modality
2 secondary outcomes
Rate of complications
Time frame: Through study completion, an average of 30 days
Cost of stay
Time frame: Through study completion, an average of 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Background: PubMed 30427892Martinez-Jimenez MA, Ramirez-GarciaLuna JL, Kolosovas-Machuca ES, Drager J, Gonzalez FJ. Development and validation of an algorithm to predict the treatment modality of burn wounds using thermographic scans: Prospective cohort study. PLoS One. 2018 Nov 14;13(11):e0206477. doi: 10.1371/journal.pone.0206477. eCollection 2018.
- Background: PubMed 23111601Medina-Preciado JD, Kolosovas-Machuca ES, Velez-Gomez E, Miranda-Altamirano A, Gonzalez FJ. Noninvasive determination of burn depth in children by digital infrared thermal imaging. J Biomed Opt. 2013 Jun;18(6):061204. doi: 10.1117/1.JBO.18.6.061204.
- Background: PubMed 21338404Kolosovas-Machuca ES, Gonzalez FJ. Distribution of skin temperature in Mexican children. Skin Res Technol. 2011 Aug;17(3):326-31. doi: 10.1111/j.1600-0846.2011.00501.x. Epub 2011 Feb 22.
- Individual participant dataSharing planned: No
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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.
Jose L Ramirez Garcia Luna, MD, MSc study chair
Universidad Autonoma de San Luis Potosi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment algorithm and Current treatment in people with Burns, run by Hospital Central "Dr. Ignacio Morones Prieto" at 1 site in Mexico.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Feb 2020. 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 Mexico. 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?
Results are not available in the source record.
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?
Length of stay (time frame: Through study completion, an average of 30 days). The study lists 2 primary outcomes in all. 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 NCT03876340, which also lists 3 linked publications.
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 13 Feb 2020; AzTrials last refreshed its copy on 7 Nov 2026.