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

• ClinicalTrials.gov Identifier: NCT03343353
• Recruitment Status: Unknown
• First Posted: November 17, 2017
• Last Update Posted: November 21, 2017
• Sponsor: University of Sao Paulo
• Information provided by (Responsible Party): Rinaldo Roberto de Jesus Guirro, University of Sao Paulo

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.

Condition or disease	Intervention/treatment	Phase
Burn Injury	Other: LED (Light Emission Diode)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

Intervention Model Description

Volunteers will be randomized into groups:

Group Sham= 35 Group red LED= 35 Group infrared LED = 35

• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Therapy by Led (Light Emission Diode) in Cutaneous Lesion: in Vivo
• Estimated Study Start Date: February 19, 2018
• Estimated Primary Completion Date: February 19, 2020
• Estimated Study Completion Date: February 19, 2020

Arms and Interventions

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.	Other: LED (Light Emission Diode); LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns
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.	Other: LED (Light Emission Diode); LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns
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.	Other: LED (Light Emission Diode); LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns

Outcome Measures

Primary Outcome Measures :

1. Detachment of the primary dressing [ Time Frame: 2 weeks ]
   Skin re-epithelialization

Secondary Outcome Measures :

1. The Vancouver Scar Scale (VSS) [ Time Frame: 2 weeks ]
   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.
2. Digital Photography [ Time Frame: 2 weeks ]
   Analysis of the size and characteristics of the skin donor area by Image J software
3. Infrared Thermography [ Time Frame: 2 weeks ]

   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.

4. Bioimpedance [ Time Frame: 2 weeks ]
   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).
5. Infrared Plesthysmography [ Time Frame: 2 weeks ]
   Changes in the microvascular blood volume of the tissue around the wound

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Brazil

University of Sao Paulo

Ribeirao Preto, Sao Paulo, Brazil

Flávia Fernanda de Oliveira Assunção

Ribeirão Preto, São Paulo, Brazil, 14095050

Contact: Flávia Fernanda de O Assunção 16997108798 flaviafassuncao@hotmail.com

Sponsors and Collaborators

University of Sao Paulo

More Information

• Responsible Party: Rinaldo Roberto de Jesus Guirro, Professor Doctoral, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT03343353
• Other Study ID Numbers: Therapy led in lesion
• First Posted: November 17, 2017
• Last Update Posted: November 21, 2017
• Last Verified: November 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rinaldo Roberto de Jesus Guirro, University of Sao Paulo:

burn injury, phototherapy, wound healing

Additional relevant MeSH terms:

Burns; Wounds and Injuries