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

NCT05112068 | Completed

• 1 other identifier: NMSC-01-21
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• incidence rate of skin lesions

  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.

  From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months

Secondary Outcomes (5)

• infectious complications rate

  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

• duration of hospitalization

  From the date of admission to the hospital until the date of discharge from hospital, 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

• 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

Study Arms (2)

Control group

Other: traditional skin care method

Experimental group

Other: method using specialized gloves

Interventions

traditional skin care method 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.

Control group

method using specialized gloves 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.

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study includes patients admitted to an ICU.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Pirogov National Medical and Surgical Center

Moscow, 105037, Russia

Location

MeSH Terms

Conditions

Pressure Ulcer; Cross Infection

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2021
• First Posted: November 8, 2021
• Study Start: September 4, 2016
• Primary Completion: June 11, 2017
• Study Completion: August 11, 2017
• Last Updated: November 8, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 6 months after completion of the study
• Access Criteria: upon the request

Locations

RU (1)