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

NCT03343353 | Unknown DMC

• 1 other identifier: Therapy led in lesion
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

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.

Conditions

Burn Injury

Keywords

burn injury, phototherapy, wound healing

Outcome Measures

Primary Outcomes (1)

• Detachment of the primary dressing

  Skin re-epithelialization

  2 weeks

Secondary Outcomes (5)

• The Vancouver Scar Scale (VSS)

  2 weeks

• Digital Photography

  2 weeks

• Infrared Thermography

  2 weeks

• Bioimpedance

  2 weeks

• Infrared Plesthysmography

  2 weeks

Study Arms (3)

LED red group (630nm)

EXPERIMENTAL

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 infrared group (940nm)

EXPERIMENTAL

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)

Group Sham

SHAM COMPARATOR

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)

Interventions

LED (Light Emission Diode) OTHER

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

Group Sham; LED infrared group (940nm); LED red group (630nm)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (2)

Flávia Fernanda de Oliveira Assunção

Ribeirão Preto, São Paulo, 14095050, Brazil

Location

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctoral

Model Details: Volunteers will be randomized into groups: Group Sham= 35 Group red LED= 35 Group infrared LED = 35

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 17, 2017
• Study Start: February 19, 2018
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: November 21, 2017

Record last verified: 2017-11

Locations

BR (2)