Effects of Patient-centered Skin Care in Critical Care

March 7, 2025 updated by: TUĞBA YENİ, Istanbul Bilgi University

The Effects of Patient-Centred Skin Care on Barrier Functions of Skin in Critical Patients: Randomised-Controlled Trial

Many critical diseases can damage skin and tissue integrity due to natural immobility, hemodynamic instability, poor tissue perfusion, use of medical devices and many other internal and external factors. Skin damage frequently seen in intensive care units; It can be listed as skin tears and secondary cutaneous infections, especially pressure injuries (PI) and incontinence-associated dermatitis (IAD). In the DecubICU's study, which has the largest sample number ever, published in 2021, the prevalence of pressure ulcers and related factors in 1117 intensive care units from 90 different countries were evaluated; Pressure ulcers were detected in 6747 of 13,254 patients hospitalized in the ICU, and 57% of these wounds were reported to be associated with the intensive care unit.

In addition to pressure injuries, another skin problem that has also been focused on in nursing science in the last 10 years; incontinence-associated dermatitis. IAD, which develops on the skin exposed to urine and faeces, is not only a skin damage that needs to be examined on its own, but also paves the way for the development of pressure sores and can also progress together with pressure injuries. The study which was published in 2018, examined 109 intensive care patients, while the incidence of IAD was determined as 23.6%, while in 2019 another study in which 351 patients were included for 52 weeks, annual prevalence of IAD ranged from 17% and weekly incidences ranged from 0-70%. The findings of three different studies conducted in the intensive care unit are that IAD developed in 6% of 112 patients, 26.2% of 145 patients, and 65.4% of 266 patients, respectively. However, despite the limited literature, the high prevalence rates and the strong relationship between pressure injuries and incontinence associated dermatitis point to the necessity of evaluating these two skin injuries together.

Each existing skin injury reduces the quality of life by causing pain and pain to the individual, and also increases hospitalizations and infection rates, placing a financial burden on the health system and causing loss of workforce. For all these reasons, skin problems are considered as a quality indicator in hospitals and the primary responsibility for maintaining skin integrity is attributed to nurses. Guidelines published by EPUAP, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance (PPPIA) in 2019 in the prevention of pressure injuries in intensive care units play a key role in determining nurses' attempts to preserve skin and tissue integrity. In the prevention of incontinence-related dermatitis, the best practices guide published by Dimitri Beckmann in 2015 should be integrated into clinics.

Furthermore, the person-centered approach in skin care has been considered as a concept that should be focused on by the authors in recent years, and in a systematic review published in 2020, clinical applications of the person-centered care approach in wound care were suggested by considering the current evidence. However, the resources in which prevention strategies are focused on individual-centered care are very limited. Therefore, in this study, it was aimed to develop a critical patient-centered skin care protocol and to examine the effects of this protocol on the barrier functions of the skin.

HYPOTHESES AND DETAILED AIMS ARE BELOW.

The primary aim of the study is to examine the effect of critical patient centered skin care on the barrier function of the skin. The hypotheses for the primary purpose of this study are as follows:

  • H1a: The mean TEWL is lower in ICU patients receiving patient-centred care than in those receiving standard care.
  • H1b: The mean skin pH is more acidic in ICU patients receiving patient-centred care than in those receiving standard care.
  • H1c: The PI risk is lower in ICU patients receiving patient-centred care than in those receiving standard care.
  • H1d: The incidence of PI is lower in ICU patients receiving patient-centred care than in those receiving standard care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Beykoz State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Taking care in the ICU for 24 hours as a stable patient,
  • Glasgow coma scale to be at least 10 points,
  • Having at least one of the urinary/fecal/mixed incontinence types,
  • Being treated in the intensive care unit for at least 7 days,
  • Being over 18 years old

Exclusion Criteria:

  • Being after cardiopulmonary resuscitation (post CPR),
  • Brain death has occurred,
  • Having had multiple trauma,
  • Being diagnosed with allergic asthma
  • Having any skin health problem before ICU admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient-centered skin care group
A patient-centered skin care protocol developed according to the Stetler Model will be applied to the experimental group.
Other: Critical Patient-Centered Skin Care Protocol

A patient-centered skin care protocol prepared by the researchers in accordance with the Stetler Model will be applied to the experimental group.

Sub-titles of this protocol; evaluation of risk factors, examination of the skin from head to toe, skin hygiene, examining the effects of critical illness on the skin, mobilization and re-positioning, incontinence management, maintaining nutrition, and using a support surface. For each sub-heading, application items regarding patient demands and suggestions will be added.
No Intervention: Routine skin care group
The routine skin care of the ICU will be applied to the control group during the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of transepidermal water loss
Time Frame: This parameter will be measured through study completion for every day
This outcome includes transepidermal water loss. It will be assessed by researcher with VapoMeter.
This parameter will be measured through study completion for every day
Change of skin pH
Time Frame: This parameter will be measured through study completion for every day
This outcome includes skin pH changing. It will be assessed by researcher with pHmeter.
This parameter will be measured through study completion for every day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of pressure injuries
Time Frame: Patients included during the study will be followed for at least 4 days or through the hospitalization
Pressure injuries will be assessed according to the EPUAP stage system
Patients included during the study will be followed for at least 4 days or through the hospitalization
Risk score of pressure injuries
Time Frame: Patients included during the study will be followed for at least 4 days or through the hospitalization
Scale is used for risk detection
Patients included during the study will be followed for at least 4 days or through the hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Bilgi University

Collaborators

University of Southampton
Istanbul University - Cerrahpasa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 12, 2024

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

July 8, 2023

First Posted (Actual)

July 17, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/81

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All results of the project will be shared by researcher via publishing.

IPD Sharing Time Frame

Sharing will be possible in a year. And it is available for unlimited time. Tugba Yeni as a first author is responsible for sharing.

IPD Sharing Access Criteria

Researcher worked with ICU patients and tissue viability can access to research results.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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