Pressure InjuryNCT05948306
Effects of Patient-centered Skin Care in Critical Care
A study testing Critical Patient-Centered Skin Care Protocol in people with Pressure Injury and Transepidermal Water Loss, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injury, Transepidermal Water Loss, sk
- What is being tested?
- Critical Patient-Centered Skin Care Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2023to 12 Jul 2024
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Pressure Injury, Transepidermal Water Loss, sk
- Being tested
- Critical Patient-Centered Skin Care Protocol
- Keywords
- pressure injury, patient-centered care, skin care protocol, transepidermal waterloss, skin properties
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical Patient-Centered Skin Care ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient-centered skin care group | Experimental | A patient-centered skin care protocol developed according to the Stetler Model will be applied to the experimental group. Receives: Other: Critical Patient-Centered Skin Care Protocol |
| Routine skin care group | No intervention | The routine skin care of the ICU will be applied to the control group during the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of transepidermal water loss
This outcome includes transepidermal water loss. It will be assessed by researcher with VapoMeter.
Measured: This parameter will be measured through study completion for every day
Change of skin pH
This outcome includes skin pH changing. It will be assessed by researcher with pHmeter.
Measured: This parameter will be measured through study completion for every day
Secondary outcomes (2)
Incidence of pressure injuries
Pressure injuries will be assessed according to the EPUAP stage system
Measured: Patients included during the study will be followed for at least 4 days or through the hospitalization
Risk score of pressure injuries
Scale is used for risk detection
Measured: Patients included during the study will be followed for at least 4 days or through the hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start27 Sep 2023
- Primary completion30 Jun 2024
- Study completion12 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was planned as a randomized controlled trial including experimental and control groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, University of Southampton
- Responsible party
- Principal investigator, TUĞBA YENİ, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05948306
- Sponsor's protocol ID
- 2022/81
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All results of the project will be shared by researcher via publishing.
Publications
Campbell J, Cook JL, Doubrovsky A, Vann A, McNamara G, Coyer F. Exploring Incontinence-Associated Dermatitis in a Single Center Intensive Care Unit: A Longitudinal Point Prevalence Survey. J Wound Ostomy Continence Nurs. 2019 Sep/Oct;46(5):401-407. doi: 10.1097/WON.0000000000000571.
PubMed 31513128Gethin G, Probst S, Stryja J, Christiansen N, Price P. Evidence for person-centred care in chronic wound care: A systematic review and recommendations for practice. J Wound Care. 2020 Sep 1;29(Sup9b):S1-S22. doi: 10.12968/jowc.2020.29.Sup9b.S1.
PubMed 32935648Johansen E, Lind R, Sjobo B, Petosic A. Moisture associated skin damage (MASD) in intensive care patients: A Norwegian point-prevalence study. Intensive Crit Care Nurs. 2020 Oct;60:102889. doi: 10.1016/j.iccn.2020.102889. Epub 2020 Jun 11.
PubMed 32536519Telser E. [Pharmaceutic incompatibilities--pharmaceutically undesirable conditions--in feed drugs. II. Chemical incompatibilities]. Dtsch Tierarztl Wochenschr. 1979 Feb 5;86(2):69-73. No abstract available. German.
PubMed 33034Valls-Matarin J, Del Cotillo-Fuente M, Ribal-Prior R, Pujol-Vila M, Sandalinas-Mulero I. Incidence of moisture-associated skin damage in an intensive care unit. Enferm Intensiva. 2017 Jan-Mar;28(1):13-20. doi: 10.1016/j.enfi.2016.11.001. Epub 2017 Jan 16. English, Spanish.
PubMed 28110903Wang X, Zhang Y, Zhang X, Zhao X, Xian H. Incidence and risk factors of incontinence-associated dermatitis among patients in the intensive care unit. J Clin Nurs. 2018 Nov;27(21-22):4150-4157. doi: 10.1111/jocn.14594. Epub 2018 Jul 26.
PubMed 29964368Wei L, Bao Y, Chai Q, Zheng J, Xu W. Determining Risk Factors to Develop a Predictive Model of Incontinence-associated Dermatitis Among Critically Ill Patients with Fecal Incontinence: A Prospective, Quantitative Study. Wound Manag Prev. 2019 Apr;65(4):24-33.
PubMed 30994472European Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide. Emily Haesler (Ed.). EPUAP/NPIAP/PPPIA: 2019.
Beeckman D et al. Proceedings of the Global IAD Expert Panel. Incontinence- associated dermatitis: moving prevention forward. Wounds International 2015.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Patient-Centred Skin Care on Barrier Functions of Skin in Critical Patients: Randomised-Controlled Trial
- ClinicalTrials.gov ID
- NCT05948306
- Acronym / sponsor ID
- 2022/81
- Conditions
- Pressure Injury, Transepidermal Water Loss, sk
- Keywords
- pressure injury, patient-centered care, skin care protocol, transepidermal waterloss, skin properties
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa, University of Southampton
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 12 Jul 2024 (actual)
- First posted
- 17 Jul 2023 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study was planned as a randomized controlled trial including experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| Patient-centered skin care group | Experimental | Other: Critical Patient-Centered Skin Care ProtocolA patient-centered skin care protocol developed according to the Stetler Model will be applied to the experimental group. |
| Routine skin care group | No intervention | –The routine skin care of the ICU will be applied to the control group during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Critical Patient-Centered Skin Care ProtocolA 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. | Other | Patient-centered skin care group |
Primary outcome
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.
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.
2 secondary outcomes
Incidence of pressure injuries
Time frame: 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
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 11 Mar 2025.
- Results publication: PubMed 31513128Campbell J, Cook JL, Doubrovsky A, Vann A, McNamara G, Coyer F. Exploring Incontinence-Associated Dermatitis in a Single Center Intensive Care Unit: A Longitudinal Point Prevalence Survey. J Wound Ostomy Continence Nurs. 2019 Sep/Oct;46(5):401-407. doi: 10.1097/WON.0000000000000571.
- Results publication: PubMed 32935648Gethin G, Probst S, Stryja J, Christiansen N, Price P. Evidence for person-centred care in chronic wound care: A systematic review and recommendations for practice. J Wound Care. 2020 Sep 1;29(Sup9b):S1-S22. doi: 10.12968/jowc.2020.29.Sup9b.S1.
- Results publication: PubMed 32536519Johansen E, Lind R, Sjobo B, Petosic A. Moisture associated skin damage (MASD) in intensive care patients: A Norwegian point-prevalence study. Intensive Crit Care Nurs. 2020 Oct;60:102889. doi: 10.1016/j.iccn.2020.102889. Epub 2020 Jun 11.
- Results publication: PubMed 33034Telser E. [Pharmaceutic incompatibilities--pharmaceutically undesirable conditions--in feed drugs. II. Chemical incompatibilities]. Dtsch Tierarztl Wochenschr. 1979 Feb 5;86(2):69-73. No abstract available. German.
- Results publication: PubMed 28110903Valls-Matarin J, Del Cotillo-Fuente M, Ribal-Prior R, Pujol-Vila M, Sandalinas-Mulero I. Incidence of moisture-associated skin damage in an intensive care unit. Enferm Intensiva. 2017 Jan-Mar;28(1):13-20. doi: 10.1016/j.enfi.2016.11.001. Epub 2017 Jan 16. English, Spanish.
- Results publication: PubMed 29964368Wang X, Zhang Y, Zhang X, Zhao X, Xian H. Incidence and risk factors of incontinence-associated dermatitis among patients in the intensive care unit. J Clin Nurs. 2018 Nov;27(21-22):4150-4157. doi: 10.1111/jocn.14594. Epub 2018 Jul 26.
- Results publication: PubMed 30994472Wei L, Bao Y, Chai Q, Zheng J, Xu W. Determining Risk Factors to Develop a Predictive Model of Incontinence-associated Dermatitis Among Critically Ill Patients with Fecal Incontinence: A Prospective, Quantitative Study. Wound Manag Prev. 2019 Apr;65(4):24-33.
- Results publicationEuropean Pressure Ulcer Advisory Panel, National Pressure Injury Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers/Injuries: Quick Reference Guide. Emily Haesler (Ed.). EPUAP/NPIAP/PPPIA: 2019.
- Results publicationBeeckman D et al. Proceedings of the Global IAD Expert Panel. Incontinence- associated dermatitis: moving prevention forward. Wounds International 2015.
- Individual participant dataSharing planned: Yes. All results of the project will be shared by researcher via publishing.
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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?
A study testing Critical Patient-Centered Skin Care Protocol in people with Pressure Injury and Transepidermal Water Loss, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 11 Mar 2025. 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 Turkey (Türkiye). 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?
Change of transepidermal water loss (time frame: This parameter will be measured through study completion for every day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05948306, which also lists 9 linked publications.
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 11 Mar 2025.