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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: TUĞBA ERDEM, PhD
- 전화번호: +90 532 739 15 01
- 이메일: tyeni@ku.edu.tr
연구 장소
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Istanbul, 터키 (Türkiye), 34000
- Koç University
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연락하다:
- TUĞBA ERDEM, PhD
- 전화번호: +90 532 739 1501
- 이메일: tyeni@ku.edu.tr
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연락하다:
- Meryem YILDIZ AYVAZ, PhD
- 전화번호: +90 554 379 8373
- 이메일: mayvaz@ku.edu.tr
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부수사관:
- EVREN ŞENTÜRK, PROFESSOR
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부수사관:
- EREN AÇIK, Medical Doctor
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부수사관:
- ŞÜKRAN GURA, MSc Nurse
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부수사관:
- MERYEM YILDIZ AYVAZ, PhD
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수석 연구원:
- TUĞBA ERDEM, PhD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in transepidermal water loss (TEWL) in pressure injury-prone anatomical regions
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in skin surface pH in pressure injury-prone anatomical regions
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 425S012
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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