Burn InjuryNCT03343353
Therapy by Led (Light Emission Diode) in Cutaneous Lesion: in Vivo
A study testing LED (Light Emission Diode) in people with Burn Injury, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
Light Emitting Diode (LED) therapy has been investigated in burns and skin ulcers, as it has a bactericidal effect and promotes tissue repair. This study aims to evaluate LED therapy at different wavelengths in the healing process of graft donor area in adult burn victims. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Burn Injury
- What is being tested?
- LED (Light Emission Diode)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 2 sitesBrazil
- Study dates
- 19 Feb 2018to 19 Feb 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients admitted to the Burn Unit of the HCFMRP-USP - Emergency Unit, who agree to participate in the study and are over 18 years of age, guided and without diagnosis of psychiatric diseases, who have undergone graft surgery for a maximum of 24 hours, with a body mass index greater than 16 kg / m² and without infection (sepsis), and that do not present any factor that could interfere in healing such as diabetes or the use of corticosteroids.
- Exclusion Criteria: patients who develop infection, are not adherent to treatment or are willing to not continue to participate in the research are excluded.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Flávia Fernanda de Oliveira Assunção
Ribeirão Preto, São Paulo, 14095050
Flávia Fernanda de O Assunção, 16997108798, flaviafassuncao@hotmail.com
University of Sao Paulo
Ribeirão Preto, São Paulo
About this study
Light Emitting Diode (LED) therapy has been investigated in burns and skin ulcers, as it has a bactericidal effect and promotes tissue repair. This study aims to evaluate LED therapy at different wavelengths in the healing process of graft donor area in adult burn victims.
Read the detailed description
It is a blinded and controlled clinical trial in which burned adult patients will be selected, who will be irradiated with red (630 nm) and infrared (940 nm) LEDs at 4J / cm2 fluency, in the donor area of until complete reepithelialization. Patients included will be the donor scalp area, with withdrawal of 0.2 mm. For application of the LEDs, the device will be calibrated for wavelength parameters, beam divergence, nominal power and fluency in the photobiophysical laboratory of the University of Ribeirão Preto - SP. Three groups will be divided: GS = Sham group (will not receive LED irradiation), will only receive routine hospital care, GT-V = treatment group with red led, and GT-IV = treatment group with infrared led. Patients will be randomized for group distribution. The donor areas will be evaluated by infrared thermography, computerized bioimpedance, infrared plethysmography, and Vancouver healing scale at two times, the first within a period of up to 24 hours after graft surgery, and the second after release of the primary dressing. The evaluations will be carried out by an expert evaluator, blind to the groups. For the analysis of the results will be applied statistical tests intra and intergroup (p <0.05). This research aims to contribute with a new therapeutic method in the control of infections commonly found in cutaneous lesions, as well as in the healing process of the skin.
- Conditions
- Burn Injury
- Being tested
- LED (Light Emission Diode)
- Keywords
- burn injury, phototherapy, wound healing
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED (Light Emission Diode)Other
LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns
| Study group | Role | What they receive |
|---|---|---|
| LED red group (630nm) | Experimental | The leds will initially be measured in the photobiophysics laboratory of the University of São Paulo - Ribeirão Preto, regarding wavelength parameters, beam divergence, nominal power and fluency. The application will be in the graft donor area (scalp) of burn patients. The applied fluence will be 4J / cm2. Receives: Other: LED (Light Emission Diode) |
| LED infrared group (940nm) | Experimental | The leds will initially be measured in the photobiophysics laboratory of the University of São Paulo - Ribeirão Preto, regarding wavelength parameters, beam divergence, nominal power and fluency. The application will be in the graft donor area (scalp) of burn patients. The applied fluence will be 4J / cm2. Receives: Other: LED (Light Emission Diode) |
| Group Sham | Sham comparator | This group will not receive irradiation by led light. You will only receive the routine care of the hospital unit to which you are hospitalized. These patients will be evaluated in the same way as the other two intervention groups, and also by a blind evaluator. Receives: Other: LED (Light Emission Diode) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detachment of the primary dressing
Skin re-epithelialization
Measured: 2 weeks
Secondary outcomes (5)
The Vancouver Scar Scale (VSS)
This scale evaluates the skin in four questions: pigmentation (3 items), vascularization (4 items), malleability (6 items) and scar height (4 itns). It is in the public domain and will be applied by the researcher to evaluate the donor area. Originally developed in the English language by Sullivan et al. (1990), adapted and validated for Portuguese by Santos, Tibola and Marques (2014). The final score varies from 0 to 13, being the lowest score corresponding to the best result (better quality of the scar). The scores are added to each item, and the lower the score, the better the quality of the scar.
Measured: 2 weeks
Digital Photography
Analysis of the size and characteristics of the skin donor area by Image J software
Measured: 2 weeks
Infrared Thermography
Quantitative analysis of skin temperature difference. Skin temperature (Celsius Degree). This evaluation seeks to find possible temperature differences between samples. With precision of up to 0.05 ° C, emissivity of 0.98 will be established, with three infrared images in sequence, and the distance between the thermograph and the donor area will be determined after a pilot test for the scalp regions, thus allowing the best framing and resolution of the area to be evaluated. An infrared thermograph model T400 (FLIR, Wilsonville, United States) will be used.
The analysis of the images will be by the software QuickReport, version 1.2.
Measured: 2 weeks
Bioimpedance
Analysis of the electrical resistance of the skin donor area. The electrical impedance of the tissue in the healthy skin donor region will be evaluated by the Biodynamics 450® bioimpedance instrument (mark, city, state, country), in which the phase angle in the 50 KHz frequency will be obtained. To do this, prior to the examination, the volunteer will remain in the supine position for 10 minutes, in a room with controlled temperature (22 ± 2ºC) and humidity of 50%. The measurements will be collected by four electrodes that will be coupled 1 cm from the edge of the lesion, for further processing and analysis, being this a relevant parameter to evaluate the effectiveness of the treatment in the process of wound healing (Moore et al., 2011). The impedance between the electrodes will be expressed in kiloohms (KΩ).
Measured: 2 weeks
Infrared Plesthysmography
Changes in the microvascular blood volume of the tissue around the wound
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start19 Feb 2018 (estimated)
- Primary completion19 Feb 2020 (estimated)
- Study completion19 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Volunteers will be randomized into groups: Group Sham= 35 Group red LED= 35 Group infrared LED = 35
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343353
- Sponsor's protocol ID
- Therapy led in lesion
- Status last verified
- Nov 2017
- First submitted
- 27 Oct 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapy by Led (Light Emission Diode) in Cutaneous Lesion: in Vivo
- ClinicalTrials.gov ID
- NCT03343353
- Acronym / sponsor ID
- Therapy led in lesion
- Conditions
- Burn Injury
- Keywords
- burn injury, phototherapy, wound healing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 19 Feb 2018 (estimated)
- Primary completion
- 19 Feb 2020 (estimated)
- Study completion
- 19 Feb 2020 (estimated)
- First posted
- 17 Nov 2017 (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.
Light Emitting Diode (LED) therapy has been investigated in burns and skin ulcers, as it has a bactericidal effect and promotes tissue repair. This study aims to evaluate LED therapy at different wavelengths in the healing process of graft donor area in adult burn victims.
Detailed description
It is a blinded and controlled clinical trial in which burned adult patients will be selected, who will be irradiated with red (630 nm) and infrared (940 nm) LEDs at 4J / cm2 fluency, in the donor area of until complete reepithelialization. Patients included will be the donor scalp area, with withdrawal of 0.2 mm. For application of the LEDs, the device will be calibrated for wavelength parameters, beam divergence, nominal power and fluency in the photobiophysical laboratory of the University of Ribeirão Preto - SP. Three groups will be divided: GS = Sham group (will not receive LED irradiation), will only receive routine hospital care, GT-V = treatment group with red led, and GT-IV = treatment group with infrared led. Patients will be randomized for group distribution. The donor areas will be evaluated by infrared thermography, computerized bioimpedance, infrared plethysmography, and Vancouver healing scale at two times, the first within a period of up to 24 hours after graft surgery, and the second after release of the primary dressing. The evaluations will be carried out by an expert evaluator, blind to the groups. For the analysis of the results will be applied statistical tests intra and intergroup (p <0.05). This research aims to contribute with a new therapeutic method in the control of infections commonly found in cutaneous lesions, as well as in the healing process of the skin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Volunteers will be randomized into groups: Group Sham= 35 Group red LED= 35 Group infrared LED = 35
| Arm | Type | Receives |
|---|---|---|
| LED red group (630nm) | Experimental | Other: LED (Light Emission Diode)The leds will initially be measured in the photobiophysics laboratory of the University of São Paulo - Ribeirão Preto, regarding wavelength parameters, beam divergence, nominal power and fluency. The application will be in the graft donor area (scalp) of burn patients. The applied fluence will be 4J / cm2. |
| LED infrared group (940nm) | Experimental | Other: LED (Light Emission Diode)The leds will initially be measured in the photobiophysics laboratory of the University of São Paulo - Ribeirão Preto, regarding wavelength parameters, beam divergence, nominal power and fluency. The application will be in the graft donor area (scalp) of burn patients. The applied fluence will be 4J / cm2. |
| Group Sham | Sham comparator | Other: LED (Light Emission Diode)This group will not receive irradiation by led light. You will only receive the routine care of the hospital unit to which you are hospitalized. These patients will be evaluated in the same way as the other two intervention groups, and also by a blind evaluator. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients admitted to the Burn Unit of the HCFMRP-USP - Emergency Unit, who agree to participate in the study and are over 18 years of age, guided and without diagnosis of psychiatric diseases, who have undergone graft surgery for a maximum of 24 hours, with a body mass index greater than 16 kg / m² and without infection (sepsis), and that do not present any factor that could interfere in healing such as diabetes or the use of corticosteroids.
- Exclusion Criteria: patients who develop infection, are not adherent to treatment or are willing to not continue to participate in the research are excluded.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| LED (Light Emission Diode)LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns | Other | Group Sham, LED infrared group (940nm), LED red group (630nm) |
Primary outcome
Detachment of the primary dressing
Time frame: 2 weeks
Skin re-epithelialization
5 secondary outcomes
The Vancouver Scar Scale (VSS)
Time frame: 2 weeks
Digital Photography
Time frame: 2 weeks
Infrared Thermography
Time frame: 2 weeks
Bioimpedance
Time frame: 2 weeks
Infrared Plesthysmography
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED (Light Emission Diode) in people with Burn Injury, run by University of Sao Paulo at 2 sites in Brazil.
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 2 inclusion and 0 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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. Some participants in this study may receive a placebo. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detachment of the primary dressing (time frame: 2 weeks). 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 21 Nov 2017.