Barrier Functions oF Skin in ICU: SKIN-BAR (SKIN-BAR)
28 de abril de 2026 actualizado por: Koç University
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.
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Estimado)
156
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: TUĞBA ERDEM, PhD
- Número de teléfono: +90 532 739 15 01
- Correo electrónico: tyeni@ku.edu.tr
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye), 34000
- Koc University
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Contacto:
- TUĞBA ERDEM, PhD
- Número de teléfono: +90 532 739 1501
- Correo electrónico: tyeni@ku.edu.tr
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Contacto:
- Meryem YILDIZ AYVAZ, PhD
- Número de teléfono: +90 554 379 8373
- Correo electrónico: mayvaz@ku.edu.tr
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Sub-Investigador:
- EVREN ŞENTÜRK, PROFESSOR
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Sub-Investigador:
- EREN AÇIK, Medical Doctor
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Sub-Investigador:
- ŞÜKRAN GURA, MSc Nurse
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Sub-Investigador:
- MERYEM YILDIZ AYVAZ, PhD
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Investigador principal:
- TUĞBA ERDEM, PhD
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra de probabilidad
Población de estudio
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.
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in transepidermal water loss (TEWL) in pressure injury-prone anatomical regions
Periodo de tiempo: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
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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.
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From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in skin surface pH in pressure injury-prone anatomical regions
Periodo de tiempo: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
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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.
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From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
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Change in local skin temperature in pressure injury-prone anatomical regions
Periodo de tiempo: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
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Local skin temperature measured in pressure injury-prone anatomical regions as a biophysical indicator of tissue stress and early skin barrier alteration.
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From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.
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Incidence of pressure injury during ICU stay
Periodo de tiempo: Daily from baseline through Day 13 (or until ICU discharge, whichever occurs first)
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Occurrence of new pressure injuries during ICU stay, assessed according to international pressure injury classification criteria.
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Daily from baseline through Day 13 (or until ICU discharge, whichever occurs first)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de julio de 2028
Finalización del estudio (Estimado)
1 de octubre de 2028
Fechas de registro del estudio
Enviado por primera vez
21 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de abril de 2026
Publicado por primera vez (Actual)
1 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 425S012
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan IPD
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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .