Trials / Unknown
UnknownNCT03343353
Therapy by Led (Light Emission Diode) in Cutaneous Lesion: in Vivo
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 105 (estimated)
- Sponsor
- University of Sao Paulo · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | LED (Light Emission Diode) | LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns |
Timeline
- Start date
- 2018-02-19
- Primary completion
- 2020-02-19
- Completion
- 2020-02-19
- First posted
- 2017-11-17
- Last updated
- 2017-11-21
Locations
2 sites across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03343353. Inclusion in this directory is not an endorsement.