Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- incidence rate of skin lesions
研究概览
简要总结
Skin care for seriously ill patients in the intensive care unit (ICU) is one of the key components in the prevention of serious complications that affect the treatment outcome. Bed rest, prolonged skin contact with biological secretions (urine, faeces, etc.) containing active irritating metabolic products (urea, faecal proteases, lipase, bile salts), and the use of diapers (disposable or otherwise) result in patient skin damage. Skin microbiota metabolizes urine that leads to alteration of skin pH, and promotes the propagation of opportunistic microorganisms causing infectious complications of skin and soft tissues. Additional factors, such as pressure on soft tissues, friction, or soft tissue displacement, lead to the formation of pressure sores which seriously worsens clinical results, patients' life quality, and significantly increases treatment costs. Statistics on the incidence of pressure sores in Russian medical institutions are rather scarce. It was reported that the incidence of pressure sores in hospice patients is up to 22.4%, and when assessing skin and soft tissues infections in ICU patients, the incidence of pressure sores is 28.9%.
A meta-analysis of foreign studies on the prevalence of pressure sores in ICU showed an incidence range of 7.8%-54% in studies using the methodology of the European Pressure Ulcer Advisory Panel, 6-22% in studies applying the methodology of the National Pressure Ulcer Advisory Panel, and 4.94% for a study that used the Torrance system. The probable range of the prevalence of pressure sores worldwide in intensive care facilities is from 6% to 18.5%. A recent UK randomized study found the development of new pressure sores or progression of existing ones in 15% of ICU patients with an expected stay in the ward for at least 36 hours.
Unfortunately, premorbid skin conditions that contribute to the formation of trophic disorders are largely overlooked, which results in the absence of a proper risk management system. Use of the traditional method of skin care in patients including liquid soap, napkins, and diapers can disrupt the skin barrier function and increase the risk of bedsores. This treatment method contributes to probable damage of the hydrolipid skin layer, the formation of skin microcracks, and the chemical irritation of skin, which is aggravated by frequent washing. The current trend is the use of methods that allow frequent skin washing without compromising its barrier function.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Estimated length of stay in ICU - 3 days or more.
- •Signed informed consent form.
排除标准
- •The presence of trophic skin changes (bedsores, maceration, intertrigo).
- •Allergy to any component of the investigated products for skin and hair care.
结局指标
主要结局
incidence rate of skin lesions
时间窗: From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months
The incidence of skin lesions including maceration, intertrigo, excessive dryness, micro damage, and pressure ulcers at stages I-IV will be assessed daily by physical examination during the entire stay in the ICU. The incidence rate of skin trophic disorders will be estimated as a percentage after primary completion of the trial.
次要结局
- duration of hospitalization(From the date of admission to the hospital until the date of discharge from hospital, assessed up to 6 months)
- convenience of the investigated technique(From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months)
- length of stay in ICU(From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months)
- infectious complications rate(From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months)
- in-hospital mortality rate(From the date of admission to the hospital until the date of discharge from hospital, assessed up to 6 months)