Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients

NCT ID: NCT05112068

Last Updated: 2021-11-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-04
• Study Completion Date: 2017-08-11

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.

Conditions

Pressure Ulcer

Keywords

hygienic gloves; ICU; nosocomial infections; patient skin care; pressure sores; skin lesions; critical care nursing

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group

traditional skin care method

Intervention Type: OTHER

Skin and hair care for critically ill patients will be carried out using traditional means: clean warm water, cotton diapers and napkins, liquid soap, 0.02% aqueous chlorhexidine solution, and regular shampoo.

Experimental group

method using specialized gloves

Intervention Type: OTHER

Specialized hygienic gloves soaked in a washing lotion Aqua Total Hygiene ("Cleanis", France) for skin care and Aqua Shampoo ("Cleanis", France) for hair care will be used.

According to the manufacturer's recommendation, six hygienic gloves should be used for one skin care procedure, and two gloves should be used for hair care. The care method used in the experimental group will not require additional rinsing and drying.

Interventions

traditional skin care method

Skin and hair care for critically ill patients will be carried out using traditional means: clean warm water, cotton diapers and napkins, liquid soap, 0.02% aqueous chlorhexidine solution, and regular shampoo.

Intervention Type: OTHER

method using specialized gloves

Specialized hygienic gloves soaked in a washing lotion Aqua Total Hygiene ("Cleanis", France) for skin care and Aqua Shampoo ("Cleanis", France) for hair care will be used.

According to the manufacturer's recommendation, six hygienic gloves should be used for one skin care procedure, and two gloves should be used for hair care. The care method used in the experimental group will not require additional rinsing and drying.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pirogov National Medical and Surgical Center

Moscow, , Russia

Countries

Russia

Other Identifiers

NMSC-01-21

Identifier Type: -

Identifier Source: org_study_id