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

University of Sao Paulo

Status: Unknown

Conditions: Burn Injury

Treatments: Other: LED (Light Emission Diode)

Study type: Interventional

Funder types: Other

Identifiers

NCT03343353

Therapy led in lesion

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

LED red group (630nm)

Experimental group

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.

Treatment:

Other: LED (Light Emission Diode)

LED infrared group (940nm)

Experimental group

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.

Treatment:

Other: LED (Light Emission Diode)

Group Sham

Sham Comparator group

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.

Treatment:

Other: LED (Light Emission Diode)