Clinical trial NCT05112068: Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
Official title: Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcer
Keywords: hygienic gloves
ICU
nosocomial infections
patient skin care
pressure sores
skin lesions
critical care nursing
Lead sponsor: State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study includes patients admitted to an ICU.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Estimated length of stay in ICU - 3 days or more.
2. Signed informed consent form.

Exclusion Criteria:

1. The presence of trophic skin changes (bedsores, maceration, intertrigo).
2. Allergy to any component of the investigated products for skin and hair care.

Primary outcomes:
measure: incidence rate of skin lesions
timeFrame: From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months
Secondary outcomes:
measure: infectious complications rate
timeFrame: From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months
measure: length of stay in ICU
timeFrame: From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months
measure: duration of hospitalization
timeFrame: From the date of admission to the hospital until the date of discharge from hospital, assessed up to 6 months
measure: in-hospital mortality rate
timeFrame: From the date of admission to the hospital until the date of discharge from hospital, assessed up to 6 months
measure: convenience of the investigated technique
timeFrame: From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov National Medical and Surgical Center
Study officials:
References: