The Effect of Photobiomodulation on Pressure Ulcers: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 主要终点
- The healing of pressure sores in the patients in the experimental group will be faster and more effective than in the control group.
研究概览
简要总结
Photobiomodulation Group (Intervention Group):
Before the intervention, the patient's skin sensitivity to light will be tested by applying light for 3 minutes to one-fourth of the forearm skin. If redness occurs and persists for more than 2 hours, this indicates photosensitivity, and the intervention will not be performed.
The Patient Information Form will be completed during the first meeting with the patients included in the study. Subsequently, blood values will be determined, the Patient Assessment Form will be filled out, vital signs will be measured, and then the intervention will begin. After routine wound care/cleaning procedures in the intensive care unit, without applying any medication, cream, or lotion to the wound area, red light (660 nm wavelength) will be applied to the wound area for 5 minutes at a distance of 55 cm during the first 3 days, and for 10 minutes at the same distance on the following days. This application will continue once daily for 14 days. Wound assessments will be performed, and photographs will be taken on Day 1, Day 4, Day 7, and Day 14 (Baracho et al., 2021; Viecelli et al., 2024; Lima et al., 2020).
Control Group:
The Patient Information Form will be completed during the first meeting with the patients included in the study. Subsequently, blood values will be determined, the Patient Assessment Form will be filled out, and vital signs will be measured. No intervention will be performed other than the routine wound care procedure carried out in the intensive care unit. Wound assessments will be performed, and photographs will be taken on Day 1, Day 4, Day 7, and Day 14, in the same manner as in the intervention group.
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
- Single (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
- 是
入选标准
- •Patients with Stage II pressure ulcers
- •Patients without any skin disease
- •Patients with albumin, platelet, and blood glucose levels within normal ranges
- •Patients who will stay in the intensive care unit for 14 days or longer
- •Patients with a BMI of 35 or below
- •Patients with vital signs within normal limits
- •Patients with an oxygen saturation level of 90% or above
排除标准
- •Patients who do not consent to participate in the study
- •Patients with severe nutritional problems and those who are cachectic
- •Patients with severe edema (+4 or above)
- •Patients with diabetes mellitus
- •Patients who show photosensitivity in the light sensitivity test
- •Patients with metastatic tumors, high fever, thromboangiitis obliterans, vascular insufficiency, active tuberculosis, acute soft tissue infection, pregnancy, bleeding tendency, skin sensory disorders, or skin allergies
- •Patients with acute injuries within the past 72 hours
- •Patients with a pacemaker, defibrillator, or other electronic implants
- •Patients taking medications known to cause photosensitivity
研究组 & 干预措施
photobiomodulation group
photobiomodulation intervention group
干预措施: photobiomodulation (Device)
control group
routine hospital care
结局指标
主要结局
The healing of pressure sores in the patients in the experimental group will be faster and more effective than in the control group.
时间窗: 14 days
This application will be continued once a day for 14 days and wound evaluation will be made and wound photographs will be taken on days 1, 4, 7 and 14. Wound assessment will be based on Pressure Ulcer Scale for Healing-PUSH and wound measurement(diameter).
次要结局
未报告次要终点
研究者
Hülya Elmalı Şimşek
Asst Prof
Ankara Medipol University