Barrier Functions oF Skin in ICU: SKIN-BAR
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKoç University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
156 Participants
are grouped into 2 trial groupsGroup A: Cohort 1: Patients Without Pressure Injury
Group B: Cohort 2: Patients With Pressure Injury
Trial outcomes
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.
Time frame
From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.Secondary outcomes
1
Change in skin surface pH in pressure injury-prone anatomical regions
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.
Time frame
From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.2
Change in local skin temperature in pressure injury-prone anatomical regions
Local skin temperature measured in pressure injury-prone anatomical regions as a biophysical indicator of tissue stress and early skin barrier alteration.
Time frame
From ICU admission (within the first 4 hours), 24 hours, 48 hours, 96 hours, day 13.3
Incidence of pressure injury during ICU stay
Occurrence of new pressure injuries during ICU stay, assessed according to international pressure injury classification criteria.
Time frame
Daily from baseline through Day 13 (or until ICU discharge, whichever occurs first)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Koç University
Lead sponsor
Koc University Hospital
Collaborator
Source ClinicalTrials.gov
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