Use of Blue Light Emitting Diode in the Treatment of Women With Bacterial Vaginosis: a Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Description of types of cells done by oncology and microflora cytology in women treated by blue LED of 401 +/- 5nm
研究概览
简要总结
Bacterial Vaginosis (BV) is a infectious process of the female genitourinary tract, an important health issue due to the high incidence and high rate of recurrence of the infection. Therefore, new therapeutic modalities are sought with the capacity to minimize drug side effects and reduce cases of recurrence of the disease. The objective of this study is to evaluate the clinical and microbiological response of the 401+/- 5nm blue light emitting diode (LED) in the treatment of women with bacterial vaginosis. The group of women with diagnosis of bacterial vaginosis will be submitted to the light therapy. These women will also be submitted to an evaluation and examination by a ginecologist before and after the therapy. There will also be an evaluation of the clinical condition and about the effects of the light through the questionnaire answered before and after participant's treatment. It's expected that the 41 +/- 5nm LED will destroy the VB demonstrated by laboratory examination and also improves the signs and results analyzed by the gynecologist and participants.
详细描述
A current treatment proposal is the use of blue LED of 401 +/- 5 nm wich is a light that has antimicrobial effect when exposed to endogenous porphyrin of the pathogens. This exposition produces reactive oxygen and it causes cells death with no possibilities of resistance by the bacterium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with 18 to 65 years old and with diagnosis of bacterial vaginosis
排除标准
- •women with injury seen by Pap smear, or in use of pacemaker, with diagnosis or suspicion of neoplasias, with heart diseases, pregnant or with diagnosis of epilepsy
研究组 & 干预措施
Blue LED 401 +/- 5 nm
The Blue LED 401 +/- 5 nm will be applied in the participant, in a closed room by a physiotherapist for 1 hour. The apparatus will be supported on a tripod, statically, externally, 5 cm away from the vulva abd vaginal region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol consists of only one session. This part of the study will see if there is bactericidal effect of the blue LED.
干预措施: Blue Light Emitting Diode (LED) 401 +/- 5nm (Device)
结局指标
主要结局
Description of types of cells done by oncology and microflora cytology in women treated by blue LED of 401 +/- 5nm
时间窗: 15 days
This exam will be done by the collect of vaginal secretion to analyze types of cells and organisms
Identification of bacterial vaginosis by the culture in vaginal secretion of women treated by blue LED
时间窗: 15 days
This exam will be done by the collect of vaginal secretion using a Gram exam / culture for bacteria in women treated by blue LED
Amount of clue cells quantified by fresh cytology in vaginal secretion of women treated by blu LED of 401 +/- 5nm
时间窗: 10 minutes
This exam will be done by the collect of vaginal secretion using KOH 10%
Value of vaginal pH measurement in women treated by blue LED
时间窗: 2 minutes
This exam will be done by the collect of vaginal secretion using a pH measuring tape to analyse the hydrogen potential in -log 10 \[pH+\] in women treated by blue LED. It will be used the numeric scale of pH value
次要结局
未报告次要终点