Pressure UlcerNCT05112068
Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
An observational study of Pressure Ulcer, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- traditional skin care method and method using specialized gloves
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 4 Sep 2016to 11 Aug 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study includes patients admitted to an ICU.
Who may be able to join
- Estimated length of stay in ICU - 3 days or more.
- Signed informed consent form.
Who cannot join
- The presence of trophic skin changes (bedsores, maceration, intertrigo).
- Allergy to any component of the investigated products for skin and hair care.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- traditional skin care method, method using specialized gloves
- Keywords
- hygienic gloves, ICU, nosocomial infections, patient skin care, pressure sores, skin lesions, critical care nursing
- Medical subject headings
- Pressure Ulcer, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional skin care methodOther
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.
method using specialized glovesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described Receives: Other: traditional skin care method | |
| Experimental group | Not described Receives: Other: method using specialized gloves |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The incidence of infectious complications (pneumonia, catheter-associated bloodstream infections, urinary tract infections, acute sinusitis, acute otitis) will be assessed daily during the entire stay in the ICU according to the results of diagnostic procedures (physical examination, laboratory tests and radiology procedures). The incidence rate of infectious complications will be estimated as a percentage after primary completion of the trial.
Measured: 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
Length of stay in ICU will be assessed as period of time from patient's admission to ICU to patient's transfer to another hospital unit. The mean value of this indicator measured in days will be calculated.
Measured: From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months
duration of hospitalization
Duration of hospitalization will be assessed as period of time from patient's admission to the hospital to patient's discharge. The mean value of this indicator measured in days will be calculated.
Measured: From the date of admission to the hospital until the date of discharge from hospital, assessed up to 6 months
in-hospital mortality rate
in-hospital mortality rate
Measured: 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
Medical personnel who administered study treatment will complete a "Safety, Efficacy and Convenience of Scin Care Procedures" questionnaire daily during the entire stay of patient in the ICU. The 5-item questionnaire, which assesses the simplicity of use, degree of physical effort, possibility of use without involving additional tools, patient comfort, and nursing care time. Each characteristic (except nursing time) is rated from 1 (inadmissible) to 5 (excellent) with higher scores denoting better outcomes.
Nursing time will be assessed in minutes and presented as median and interquartile range (Q1 - Q3).
Measured: From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start4 Sep 2016
- Primary completion11 Jun 2017
- Study completion11 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112068
- Sponsor's protocol ID
- NMSC-01-21
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Effectiveness and Safety of Methods for Skin and Hair Care in Severe Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT05112068
- Acronym / sponsor ID
- NMSC-01-21
- Conditions
- Pressure Ulcer
- Keywords
- hygienic gloves, ICU, nosocomial infections, patient skin care, pressure sores, skin lesions, critical care nursing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of RussiaUniversity, hospital or other
- Study start
- 4 Sep 2016 (actual)
- Primary completion
- 11 Jun 2017 (actual)
- Study completion
- 11 Aug 2017 (actual)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Other: traditional skin care method |
| Experimental group | – | Other: method using specialized gloves |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes patients admitted to an ICU.
Key inclusion criteria (2 listed)
- Estimated length of stay in ICU - 3 days or more.
- Signed informed consent form.
Key exclusion criteria (2 listed)
- The presence of trophic skin changes (bedsores, maceration, intertrigo).
- Allergy to any component of the investigated products for skin and hair care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional skin care methodSkin 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. | Other | Control group |
| method using specialized glovesSpecialized 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. | Other | Experimental group |
Primary outcome
incidence rate of skin lesions
Time frame: 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.
5 secondary outcomes
infectious complications rate
Time frame: 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
Time frame: From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months
duration of hospitalization
Time frame: From the date of admission to the hospital until the date of discharge from hospital, assessed up to 6 months
in-hospital mortality rate
Time frame: 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
Time frame: From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer, run by State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence rate of skin lesions (time frame: From the date of admission to the ICU until the date of discharge from ICU, assessed up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.