Comparison Between the Effects of Low-level Laser Therapy, High Frequency and Wound Dressing on Pressure Ulcers Treatment: a Clinical Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Changes on pressure ulcer area 28 days after first intervention
研究概览
简要总结
Patients admitted in the Emergency Service that have pressure ulcers will be selected by eligibility criteria and randomized into three groups according to the adopted therapy: wound dressing (CG); wound dressing + high-frequency generator group (GAF); and wound dressing + low-level laser therapy group (GLBP).
详细描述
Wound dressing is considered the standard treatment for pressure ulcers, however, despite its proven efficacy, it's a long-term healing process. Among Physiotherapy resources available for pressure ulcers treatment, the most used are low-level laser therapy and high-frequency generator. Even though the individual effects of both are evidenced on literature, there are no randomized clinical trials evidencing the effects of low-level laser therapy and high-frequency generator in comparison to wound dressing on pressure ulcers treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pressure ulcers with rate II or III;
- •Not receiving pressure ulcer treatment.
排除标准
- •Presence of necrotic tissue needing debridement
- •Pregnancy
- •Discomfort during treatment
- •Pressure ulcers with area bigger than 30cm2
- •Extensive tunneling
- •Diabetes mellitus (DM)
- •Severe metabolic disease
- •Use of corticosteroids or vasopressors
- •Immunosuppression
- •Pacemaker
- •Neoplasia
- •Hemorrhage
- •Sensibility disorders
- •Metalic device.
研究组 & 干预措施
Low-level laser therapy AlGaInP
AlGaInP 660 nm laser and dose of 6 J / cm 2 with point application on the edges of the lesion and sweep up application in the center.
干预措施: Low-level laser therapy AlGaInP (Device)
Low-level laser therapy AlGaInP
AlGaInP 660 nm laser and dose of 6 J / cm 2 with point application on the edges of the lesion and sweep up application in the center.
干预措施: Wound dressing with saline solution (Other)
High-frequency therapy with O3 formation
High frequency generator, spherical electrode. Direct spark technique will be used, in which the electrode is positioned millimeters away from the skin of the patient, causing the formation of sparks, with increasing intensity up to 80 to 100% for ozone formation.
干预措施: High-frequency therapy with O3 formation (Device)
High-frequency therapy with O3 formation
High frequency generator, spherical electrode. Direct spark technique will be used, in which the electrode is positioned millimeters away from the skin of the patient, causing the formation of sparks, with increasing intensity up to 80 to 100% for ozone formation.
干预措施: Wound dressing with saline solution (Other)
Wound dressing with saline solution
Wound dressing with hygiene of the pressure ulcer with warm saline and after applying the bandage will be held will be held.
干预措施: Wound dressing with saline solution (Other)
结局指标
主要结局
Changes on pressure ulcer area 28 days after first intervention
时间窗: Patients will be evaluated on the 7th, 14th, 21st and 28th day after randomized, while hospitalized. If discharge before, follow up will be done untill the last day of hospitalization.
Evaluated through absolute (mm ²) reduction according to baseline. The participants will be followed while hospitalized, and outcome measure will be assessed at 7th, 14th, 21st and 28th day after the study randomization.
次要结局
- Changes on clinical evolution of the pressure ulcer 28 days after first intervention(Patients will be evaluated on the 7th, 14th, 21st and 28th day after randomized, while hospitalized. If discharge before, follow up will be done untill the last day of hospitalization.)
- Changes on pressure ulcer relative area 28 days after first intervention(Patients will be evaluated on the 7th, 14th, 21st and 28th day after randomized, while hospitalized. If discharge before, follow up will be done untill the last day of hospitalization.)