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

NCT ID: NCT03343353

Last Updated: 2017-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-19

Study Completion Date

2020-02-19

Brief Summary

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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

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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

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Burn Injury

Keywords

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burn injury, phototherapy, wound healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Volunteers will be randomized into groups:

Group Sham= 35 Group red LED= 35 Group infrared LED = 35
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

LED (Light Emission Diode)

Intervention Type OTHER

LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns

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.

Group Type EXPERIMENTAL

LED (Light Emission Diode)

Intervention Type OTHER

LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns

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.

Group Type SHAM_COMPARATOR

LED (Light Emission Diode)

Intervention Type OTHER

LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns

Interventions

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LED (Light Emission Diode)

LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Rinaldo Roberto de Jesus Guirro

Professor Doctoral

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Flávia Fernanda de Oliveira Assunção

Ribeirão Preto, São Paulo, Brazil

Site Status

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

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Brazil

Facility Contacts

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Flávia Fernanda de O Assunção

Role: primary

Other Identifiers

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Therapy led in lesion

Identifier Type: -

Identifier Source: org_study_id