Pressure InjuriesSKIN-BARNCT07560683
Barrier Functions oF Skin in ICU: SKIN-BAR
An observational study of Pressure Injuries and Skin Failure, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate skin barrier function in intensive care unit (ICU) patients using biosensor-based measurements. Biophysical parameters including transepidermal water loss (TEWL), skin pH, stratum corneum hydration, local skin temperature, and sebum will be assessed in anatomical regions at risk for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Injuries, Skin Failure, Skin Abnormalities
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2026to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult critically ill patients admitted to the intensive care unit (ICU) and at risk for pressure injury development will be enrolled. Participants will undergo longitudinal, non-invasive biosensor-based assessments of skin barrier function in pressure injury-prone anatomical regions throughout their ICU stay. The population will include both patients who develop pressure injuries and those who do not.
Who may be able to join
- Adults aged >18 years
- Admission to the intensive care unit
- Initial skin assessment completed within the first 4 hours after ICU admission
- Hemodynamically stable enough to undergo follow-up and repeated skin measurements
- Intact skin integrity at ICU admission
- Willingness to participate in the study, with informed consent provided by the participant or legally authorized representative
Who cannot join
- Inability to tolerate position changes
- Post-cardiopulmonary resuscitation care period at enrollment
- Cardiac arrest or cardiopulmonary resuscitation during follow-up
- Severe edema or subcutaneous fluid accumulation
- Presence of skin lesions before ICU admission
- Systemic dermatologic disease directly affecting skin barrier function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Koç University
Istanbul, 34000
TUĞBA ERDEM, PhD, +90 532 739 1501, tyeni@ku.edu.tr
Meryem YILDIZ AYVAZ, PhD, +90 554 379 8373, mayvaz@ku.edu.tr
About this study
Official title: Investigation of Skin Barrier Function Using Biosensor Methods in Risky Skin Regions and Developed Pressure Injuries in Intensive Care Patients, and Identification of Influencing Factors: The SKIN-BAR Project
This study aims to investigate skin barrier function in intensive care unit (ICU) patients using biosensor-based measurements. Biophysical parameters including transepidermal water loss (TEWL), skin pH, stratum corneum hydration, local skin temperature, and sebum will be assessed in anatomical regions at risk for pressure injuries. The study will examine temporal changes in these parameters, their interrelationships, and their association with pressure injury development.
Read the detailed description
Pressure injuries (PIs) remain a major complication in intensive care units (ICUs), associated with increased morbidity, mortality, and healthcare costs. Early detection and prevention are critical; however, current assessment methods rely largely on subjective clinical evaluation and risk scales, which may lack sensitivity in detecting subclinical skin barrier impairment.
Recent advances in biosensor technology enable objective, non-invasive assessment of skin barrier function through biophysical parameters such as transepidermal water loss (TEWL), skin pH, stratum corneum hydration, local temperature, and sebum levels. These parameters reflect epidermal integrity and may provide early indicators of pressure-induced tissue damage before visible clinical signs emerge.
The SKIN-BAR study is designed as a prospective, longitudinal cohort study conducted in ICU patients. The primary objective is to evaluate skin barrier function in pressure injury-prone anatomical regions and to identify factors influencing these parameters. Specifically, the study aims to:
- assess temporal changes in biophysical skin parameters,
- examine relationships between these parameters,
- compare measurements between pressure injury-developing and non-developing patients, and
- identify clinical and demographic factors associated with impaired skin barrier function.
Data will be collected using validated, non-invasive biosensor devices. Measurements will be performed at multiple time points (including early ICU admission and follow-up intervals) and across multiple anatomical sites, including the sacrum, trochanters, scapulae, lateral legs, and posterior neck. Control measurements from adjacent intact skin will also be obtained.
A comprehensive dataset including clinical, demographic, and physiological variables will be analyzed to determine predictors of pressure injury development and to better understand the pathophysiological mechanisms underlying skin barrier disruption in critically ill patients.
This study is expected to contribute to the development of objective, evidence-based approaches for early detection and prevention of pressure injuries in ICU settings and to support the integration of biosensor technologies into clinical care protocols.
- Keywords
- barrier function of skin, pressure-prone skin areas, pressure injury, intensive care unit, biosensory, skin integrity
- Medical subject headings
- Pressure Ulcer, Skin Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Patients Without Pressure Injury | ICU patients who do not develop pressure injuries during the follow-up period. Skin barrier function parameters (TEWL, pH, stratum corneum hydration, local skin temperature) will be measured longitudinally in pressure injury-prone anatomical regions. | |
| Cohort 2: Patients With Pressure Injury | ICU patients who develop pressure injuries during the follow-up period. Skin barrier function parameters will be assessed in both pressure injury-prone regions and adjacent intact skin areas to evaluate changes associated with pressure injury development. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in transepidermal water loss (TEWL) in pressure injury-prone anatomical regions
Transepidermal water loss (TEWL) values measured using a non-invasive biosensor device in pressure injury-prone anatomical regions, including the sacrum, right and left trochanters, right and left lateral legs, right and left scapulae, and posterior neck. TEWL will be evaluated longitudinally to determine temporal changes in skin barrier function and its association with pressure injury development.
Measured: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
Secondary outcomes (3)
Change in skin surface pH in pressure injury-prone anatomical regions
Skin surface pH values measured longitudinally in pressure injury-prone anatomical regions using a non-invasive pH meter to assess changes in skin barrier acidity over time.
Measured: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
Change in local skin temperature in pressure injury-prone anatomical regions
Local skin temperature measured in pressure injury-prone anatomical regions as a biophysical indicator of tissue stress and early skin barrier alteration.
Measured: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
Incidence of pressure injury during ICU stay
Occurrence of new pressure injuries during ICU stay, assessed according to international pressure injury classification criteria.
Measured: Daily from baseline through Day 13 (or until ICU discharge, whichever occurs first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuriesStudies 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
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Koc University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560683
- Sponsor's protocol ID
- 425S012
- Acronym
- SKIN-BAR
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) sharing is currently undecided. Due to the sensitive nature of clinical data collected in an intensive care unit setting and institutional data protection policies, data sharing will be considered after study completion. Any potential data sharing will involve fully de-identified datasets and will require appropriate ethical approvals and data use agreements.
Publications
McEvoy NL, Patton D, Curley GF, Moore Z. Pressure ulcer risk assessment in the ICU. Is it time for a more objective measure? Intensive Crit Care Nurs. 2024 Aug;83:103681. doi: 10.1016/j.iccn.2024.103681. Epub 2024 Mar 21.
PubMed 38518456Abiakam NS, Jayabal H, Filingeri D, Bader DL, Worsley PR. Spatial and temporal changes in biophysical skin parameters over a category I pressure ulcer. Int Wound J. 2023 Oct;20(8):3164-3176. doi: 10.1111/iwj.14194. Epub 2023 Apr 14.
PubMed 37060199Bader DL, Worsley PR. Technologies to monitor the health of loaded skin tissues. Biomed Eng Online. 2018 Apr 12;17(1):40. doi: 10.1186/s12938-018-0470-z.
PubMed 29650012Akdeniz M, Gabriel S, Lichterfeld-Kottner A, Blume-Peytavi U, Kottner J. Transepidermal water loss in healthy adults: a systematic review and meta-analysis update. Br J Dermatol. 2018 Nov;179(5):1049-1055. doi: 10.1111/bjd.17025. Epub 2018 Sep 9.
PubMed 30022486Erdem T, Yildiz Ayvaz M, Gura SS, Acik ME, Senturk E. SKIN-BAR project: protocol for a prospective cohort study investigating skin barrier function and pressure injury development in critically ill adults. BMJ Open. 2026 Sep 21;16(9):e124660. doi: 10.1136/bmjopen-2026-124660.
PubMed 42767743
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Skin Barrier Function Using Biosensor Methods in Risky Skin Regions and Developed Pressure Injuries in Intensive Care Patients, and Identification of Influencing Factors: The SKIN-BAR Project
- ClinicalTrials.gov ID
- NCT07560683
- Acronym / sponsor ID
- SKIN-BAR / 425S012
- Keywords
- barrier function of skin, pressure-prone skin areas, pressure injury, intensive care unit, biosensory, skin integrity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Koc University Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 1 May 2026 (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.
This study aims to investigate skin barrier function in intensive care unit (ICU) patients using biosensor-based measurements. Biophysical parameters including transepidermal water loss (TEWL), skin pH, stratum corneum hydration, local skin temperature, and sebum will be assessed in anatomical regions at risk for pressure injuries. The study will examine temporal changes in these parameters, their interrelationships, and their association with pressure injury development.
Detailed description
Pressure injuries (PIs) remain a major complication in intensive care units (ICUs), associated with increased morbidity, mortality, and healthcare costs. Early detection and prevention are critical; however, current assessment methods rely largely on subjective clinical evaluation and risk scales, which may lack sensitivity in detecting subclinical skin barrier impairment.
Recent advances in biosensor technology enable objective, non-invasive assessment of skin barrier function through biophysical parameters such as transepidermal water loss (TEWL), skin pH, stratum corneum hydration, local temperature, and sebum levels. These parameters reflect epidermal integrity and may provide early indicators of pressure-induced tissue damage before visible clinical signs emerge.
The SKIN-BAR study is designed as a prospective, longitudinal cohort study conducted in ICU patients. The primary objective is to evaluate skin barrier function in pressure injury-prone anatomical regions and to identify factors influencing these parameters. Specifically, the study aims to:
- assess temporal changes in biophysical skin parameters,
- examine relationships between these parameters,
- compare measurements between pressure injury-developing and non-developing patients, and
- identify clinical and demographic factors associated with impaired skin barrier function.
Data will be collected using validated, non-invasive biosensor devices. Measurements will be performed at multiple time points (including early ICU admission and follow-up intervals) and across multiple anatomical sites, including the sacrum, trochanters, scapulae, lateral legs, and posterior neck. Control measurements from adjacent intact skin will also be obtained.
A comprehensive dataset including clinical, demographic, and physiological variables will be analyzed to determine predictors of pressure injury development and to better understand the pathophysiological mechanisms underlying skin barrier disruption in critically ill patients.
This study is expected to contribute to the development of objective, evidence-based approaches for early detection and prevention of pressure injuries in ICU settings and to support the integration of biosensor technologies into clinical care protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Patients Without Pressure Injury | – | –ICU patients who do not develop pressure injuries during the follow-up period. Skin barrier function parameters (TEWL, pH, stratum corneum hydration, local skin temperature) will be measured longitudinally in pressure injury-prone anatomical regions. |
| Cohort 2: Patients With Pressure Injury | – | –ICU patients who develop pressure injuries during the follow-up period. Skin barrier function parameters will be assessed in both pressure injury-prone regions and adjacent intact skin areas to evaluate changes associated with pressure injury development. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult critically ill patients admitted to the intensive care unit (ICU) and at risk for pressure injury development will be enrolled. Participants will undergo longitudinal, non-invasive biosensor-based assessments of skin barrier function in pressure injury-prone anatomical regions throughout their ICU stay. The population will include both patients who develop pressure injuries and those who do not.
Key inclusion criteria (6 listed)
- Adults aged >18 years
- Admission to the intensive care unit
- Initial skin assessment completed within the first 4 hours after ICU admission
- Hemodynamically stable enough to undergo follow-up and repeated skin measurements
- Intact skin integrity at ICU admission
Key exclusion criteria (6 listed)
- Inability to tolerate position changes
- Post-cardiopulmonary resuscitation care period at enrollment
- Cardiac arrest or cardiopulmonary resuscitation during follow-up
- Severe edema or subcutaneous fluid accumulation
- Presence of skin lesions 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.
Primary outcome
Change in transepidermal water loss (TEWL) in pressure injury-prone anatomical regions
Time frame: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
Transepidermal water loss (TEWL) values measured using a non-invasive biosensor device in pressure injury-prone anatomical regions, including the sacrum, right and left trochanters, right and left lateral legs, right and left scapulae, and posterior neck. TEWL will be evaluated longitudinally to determine temporal changes in skin barrier function and its association with pressure injury development.
3 secondary outcomes
Change in skin surface pH in pressure injury-prone anatomical regions
Time frame: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
Change in local skin temperature in pressure injury-prone anatomical regions
Time frame: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
Incidence of pressure injury during ICU stay
Time frame: Daily from baseline through Day 13 (or until ICU discharge, whichever occurs first)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 38518456McEvoy NL, Patton D, Curley GF, Moore Z. Pressure ulcer risk assessment in the ICU. Is it time for a more objective measure? Intensive Crit Care Nurs. 2024 Aug;83:103681. doi: 10.1016/j.iccn.2024.103681. Epub 2024 Mar 21.
- Background: PubMed 37060199Abiakam NS, Jayabal H, Filingeri D, Bader DL, Worsley PR. Spatial and temporal changes in biophysical skin parameters over a category I pressure ulcer. Int Wound J. 2023 Oct;20(8):3164-3176. doi: 10.1111/iwj.14194. Epub 2023 Apr 14.
- Background: PubMed 29650012Bader DL, Worsley PR. Technologies to monitor the health of loaded skin tissues. Biomed Eng Online. 2018 Apr 12;17(1):40. doi: 10.1186/s12938-018-0470-z.
- Background: PubMed 30022486Akdeniz M, Gabriel S, Lichterfeld-Kottner A, Blume-Peytavi U, Kottner J. Transepidermal water loss in healthy adults: a systematic review and meta-analysis update. Br J Dermatol. 2018 Nov;179(5):1049-1055. doi: 10.1111/bjd.17025. Epub 2018 Sep 9.
- Derived from this study: PubMed 42767743Erdem T, Yildiz Ayvaz M, Gura SS, Acik ME, Senturk E. SKIN-BAR project: protocol for a prospective cohort study investigating skin barrier function and pressure injury development in critically ill adults. BMJ Open. 2026 Sep 21;16(9):e124660. doi: 10.1136/bmjopen-2026-124660.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) sharing is currently undecided. Due to the sensitive nature of clinical data collected in an intensive care unit setting and institutional data protection policies, data sharing will be considered after study completion. Any potential data sharing will involve fully de-identified datasets and will require appropriate ethical approvals and data use agreements.
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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.
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 Injuries and Skin Failure, run by Koç 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 1 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TUĞBA ERDEM, PhD (+90 532 739 15 01, tyeni@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in transepidermal water loss (TEWL) in pressure injury-prone anatomical regions (time frame: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.). 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 NCT07560683, which also lists 5 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 1 May 2026.