Barrier Functions oF Skin in ICU: SKIN-BAR

NCT07560683 | Not Yet Recruiting

• 1 other identifier: 425S012
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pressure Injuries; Skin Failure; Skin Abnormalities; Biophysical Parameters of Skin

Keywords

barrier function of skin; pressure-prone skin areas; pressure injury; intensive care unit; biosensory; skin integrity

Outcome Measures

Primary Outcomes (1)

• Change in transepidermal water loss (TEWL) in pressure injury-prone anatomical regions

  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.

Secondary Outcomes (3)

• Change in skin surface pH in pressure injury-prone anatomical regions

  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

  From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.

• Incidence of pressure injury during ICU stay

  Daily from baseline through Day 13 (or until ICU discharge, whichever occurs first)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University Hospital: collaborator
• Koç University: lead

Study Sites (1)

Koç University

Istanbul, 34000, Turkey (Türkiye)

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer; Skin Abnormalities

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

TUĞBA ERDEM, PhD

CONTACT

+90 532 739 15 01; tyeni@ku.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 1, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

TU (1)