Barrier Functions oF Skin in ICU: SKIN-BAR
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Pressure Injuries, Skin Failure, Skin Abnormalities, Biophysical Parameters of Skin. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Turkey (Türkiye)
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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
Обзор
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.
Подробное описание
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:
1. assess temporal changes in biophysical skin parameters, 2. examine relationships between these parameters, 3. compare measurements between pressure injury-developing and non-developing patients, and 4. 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.
Первичные конечные точки
- Change in transepidermal water loss (TEWL) in pressure injury-prone anatomical regions [Срок оценки: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.]
Вторичные конечные точки (3)
- Change in skin surface pH in pressure injury-prone anatomical regions [Срок оценки: 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 [Срок оценки: From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.]
- Incidence of pressure injury during ICU stay [Срок оценки: Daily from baseline through Day 13 (or until ICU discharge, whichever occurs first)]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Turkey (Türkiye) · 1 центр
- Koç University — Istanbul
Публикации
- 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. PMID 38518456
- 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. PMID 37060199
- 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. PMID 29650012
- 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. PMID 30022486
Идентификаторы
NCT: NCT07560683 · 425S012