NCT05112068

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

Completed Last updated 8 November 2021

What this trial tests

trial testing traditional skin care method in Pressure Ulcer in 60 participants. Completed in 11 August 2017.

Timeline

4 September 2016

Primary endpoint
11 June 2017

11 August 2017

Quick facts

Lead sponsor	State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Status	Completed
Study type	OBSERVATIONAL
Enrollment	60
Start date	4 September 2016
Primary completion	11 June 2017
Estimated completion	11 August 2017
Sites	1 location across Russia

Drugs / interventions tested

• traditional skin care method
• method using specialized gloves

Conditions studied

• Pressure Ulcer — all drugs for Pressure Ulcer →

Sponsor

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

Who can join

18 and older, any sex, with Pressure Ulcer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.