Clinical trial NCT03343353: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Burn Injury
Keywords: burn injury, phototherapy, wound healing
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Volunteers will be randomized into groups:

Group Sham= 35 Group red LED= 35 Group infrared LED = 35
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Detachment of the primary dressing
timeFrame: 2 weeks
Secondary outcomes:
measure: The Vancouver Scar Scale (VSS)
timeFrame: 2 weeks
measure: Digital Photography
timeFrame: 2 weeks
measure: Infrared Thermography
timeFrame: 2 weeks
measure: Bioimpedance
timeFrame: 2 weeks
measure: Infrared Plesthysmography
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Ribeirao Preto
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
city: Ribeirão Preto
country: Brazil
facility: Flávia Fernanda de Oliveira Assunção
state: São Paulo
Study officials:
References: