An observational study in Pressure Injuries, Skin Failure and Skin Abnormalities, sponsored by Koç University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Koç University · Observational
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.
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:
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.
545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.
This study's planned enrollment of 156 is above the median of 138 across 110 observational studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Koç University is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
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.
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
Local skin temperature measured in pressure injury-prone anatomical regions as a biophysical indicator of tissue stress and early skin barrier alteration.
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
Occurrence of new pressure injuries during ICU stay, assessed according to international pressure injury classification criteria.
Time frame: Daily from baseline through Day 13 (or until ICU discharge, whichever occurs first)
Plan to share: 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.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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