- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03343353
Therapy by Led (Light Emission Diode) in Cutaneous Lesion: in Vivo
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sao Paulo
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Ribeirao Preto, Sao Paulo, Brazil
- University of Sao Paulo
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São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14095050
- Flávia Fernanda de Oliveira Assunção
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Contact:
- Flávia Fernanda de O Assunção
- Phone Number: 16997108798
- Email: flaviafassuncao@hotmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LED red group (630nm)
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.
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LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns
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Experimental: LED infrared group (940nm)
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 light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns
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Sham Comparator: Group Sham
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.
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LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detachment of the primary dressing
Time Frame: 2 weeks
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Skin re-epithelialization
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Vancouver Scar Scale (VSS)
Time Frame: 2 weeks
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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.
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2 weeks
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Digital Photography
Time Frame: 2 weeks
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Analysis of the size and characteristics of the skin donor area by Image J software
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2 weeks
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Infrared Thermography
Time Frame: 2 weeks
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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. |
2 weeks
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Bioimpedance
Time Frame: 2 weeks
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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).
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2 weeks
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Infrared Plesthysmography
Time Frame: 2 weeks
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Changes in the microvascular blood volume of the tissue around the wound
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2 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Therapy led in lesion
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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