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| Name | Class |
|---|---|
| Koc University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TUĞBA ERDEM, PhD | Contact | +90 532 739 15 01 | tyeni@ku.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koç University | Istanbul | 34000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38518456 | Background | 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. | |
| 37060199 | Background | Abiakam 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. |
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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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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D012868 | Skin Abnormalities |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000013 | Congenital Abnormalities |
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| 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. |
| 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. | Daily from baseline through Day 13 (or until ICU discharge, whichever occurs first) |
| 29650012 | Background | Bader 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. |
| 30022486 | Background | Akdeniz 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. |
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |