Barrier Functions oF Skin in ICU: SKIN-BAR (SKIN-BAR)
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
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：TUĞBA ERDEM, PhD
- 電話番号：+90 532 739 15 01
- メール：tyeni@ku.edu.tr
研究場所
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Istanbul、トルコ（Türkiye）、34000
- Koc University
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コンタクト：
- TUĞBA ERDEM, PhD
- 電話番号：+90 532 739 1501
- メール：tyeni@ku.edu.tr
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コンタクト：
- Meryem YILDIZ AYVAZ, PhD
- 電話番号：+90 554 379 8373
- メール：mayvaz@ku.edu.tr
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副調査官：
- EVREN ŞENTÜRK, PROFESSOR
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副調査官：
- EREN AÇIK, Medical Doctor
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副調査官：
- ŞÜKRAN GURA, MSc Nurse
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副調査官：
- MERYEM YILDIZ AYVAZ, PhD
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主任研究者：
- TUĞBA ERDEM, PhD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in transepidermal water loss (TEWL) in pressure injury-prone anatomical regions
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in skin surface pH in pressure injury-prone anatomical regions
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 425S012
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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