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Barrier Functions oF Skin in ICU: SKIN-BAR (SKIN-BAR)

2026年4月28日更新者：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.

研究概览

地位

尚未招聘

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

156

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：TUĞBA ERDEM, PhD
电话号码：+90 532 739 15 01
邮箱：tyeni@ku.edu.tr

学习地点

土耳其（türkiye）
- - Istanbul、土耳其（türkiye）、34000
    - Koc University
    - 接触：
      
      TUĞBA ERDEM, PhD
      
      电话号码：+90 532 739 1501
      
      邮箱：tyeni@ku.edu.tr
    - 接触：
      
      Meryem YILDIZ AYVAZ, PhD
      
      电话号码：+90 554 379 8373
      
      邮箱：mayvaz@ku.edu.tr
    - 副研究员：
      
      EVREN ŞENTÜRK, PROFESSOR
    - 副研究员：
      
      EREN AÇIK, Medical Doctor
    - 副研究员：
      
      ŞÜKRAN GURA, MSc Nurse
    - 副研究员：
      
      MERYEM YILDIZ AYVAZ, PhD
    - 首席研究员：
      
      TUĞBA ERDEM, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Change in transepidermal water loss (TEWL) in pressure injury-prone anatomical regions 大体时间：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.	From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.

次要结果测量

结果测量	措施说明	大体时间
Change in skin surface pH in pressure injury-prone anatomical regions 大体时间：From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.	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.
Change in local skin temperature in pressure injury-prone anatomical regions 大体时间：From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.	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 大体时间：Daily from baseline through Day 13 (or until ICU discharge, whichever occurs first)	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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Koç University

合作者

Koc University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2028年10月1日

研究注册日期

首次提交

2026年4月21日

首先提交符合 QC 标准的

2026年4月28日

首次发布 (实际的)

2026年5月1日

研究记录更新

最后更新发布 (实际的)