The Effect of Photobiomodulation on Pressure Ulcers

Официальное название

The Effect of Photobiomodulation on Pressure Ulcers: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Устройство photobiomodulation
  The effectiveness of photobiomodulation application in chronic wound healing will be evaluated.

Первичные конечные точки

• The healing of pressure sores in the patients in the experimental group will be faster and more effective than in the control group. [Срок оценки: 14 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07307885 · Ankaramedipol · university

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗