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Therapy by Led (Light Emission Diode) in Cutaneous Lesion: in Vivo

Primary Purpose

Burn Injury

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
LED (Light Emission Diode)
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn Injury focused on measuring burn injury, phototherapy, wound healing

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Sao Paulo
  • Flávia Fernanda de Oliveira Assunção

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

LED red group (630nm)

LED infrared group (940nm)

Group Sham

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Detachment of the primary dressing
Skin re-epithelialization

Secondary Outcome Measures

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.
Digital Photography
Analysis of the size and characteristics of the skin donor area by Image J software
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.
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).
Infrared Plesthysmography
Changes in the microvascular blood volume of the tissue around the wound

Full Information

First Posted
October 27, 2017
Last Updated
November 17, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03343353
Brief Title
Therapy by Led (Light Emission Diode) in Cutaneous Lesion: in Vivo
Official Title
Therapy by Led (Light Emission Diode) in Cutaneous Lesion: in Vivo
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 19, 2018 (Anticipated)
Primary Completion Date
February 19, 2020 (Anticipated)
Study Completion Date
February 19, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Injury
Keywords
burn injury, phototherapy, wound healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Volunteers will be randomized into groups: Group Sham= 35 Group red LED= 35 Group infrared LED = 35
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LED red group (630nm)
Arm Type
Experimental
Arm Description
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.
Arm Title
LED infrared group (940nm)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
LED (Light Emission Diode)
Intervention Description
LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns
Primary Outcome Measure Information:
Title
Detachment of the primary dressing
Description
Skin re-epithelialization
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
The Vancouver Scar Scale (VSS)
Description
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.
Time Frame
2 weeks
Title
Digital Photography
Description
Analysis of the size and characteristics of the skin donor area by Image J software
Time Frame
2 weeks
Title
Infrared Thermography
Description
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.
Time Frame
2 weeks
Title
Bioimpedance
Description
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).
Time Frame
2 weeks
Title
Infrared Plesthysmography
Description
Changes in the microvascular blood volume of the tissue around the wound
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Sao Paulo
City
Ribeirao Preto
State/Province
Sao Paulo
Country
Brazil
Facility Name
Flávia Fernanda de Oliveira Assunção
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14095050
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flávia Fernanda de O Assunção
Phone
16997108798
Email
flaviafassuncao@hotmail.com

12. IPD Sharing Statement

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Therapy by Led (Light Emission Diode) in Cutaneous Lesion: in Vivo

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