Clinical trial NCT02930590: Effects of Different Support Surfaces on the Properties Skin After Loading
Official title: Comparing the Effects of Three Different Support Surfaces on the Properties of Heel and Sacral Skin After Loading
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcers
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 15
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide. There is common agreement, that effective pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. Besides risk assessment and repositioning the use of special pressure ulcer preventive support surfaces are the key interventions in pressure ulcer prevention. Pressure ulcer preventive support surface modify the degree of skin and tissue deformation and/or skin temperature and moisture. Therefore, an association between the type and working mechanism of a pressure ulcer support surface and skin function after loading is highly likely. Furthermore, such a relationship may be used to characterize and/or to quantify the performance pressure ulcer support surfaces in terms of skin protection. The overall aim of this explorative study is to measure skin responses of the two most common pressure ulcer predilection sites (heel, sacral skin) after two hours loading on three different support surfaces and the sternal skin (control area).


Eligibility criteria: Inclusion Criteria:

* Healthy, female volunteers
* 60 to 80 years
* Body Mass Index between 18.5 and 29.9 kg/m2
* Non-Smoker of at least one year
* Absence of skin diseases or scars in the skin areas of interest
* Ability to move independently and to maintain supine and prone positions
* Able to give written informed consent
* No use of cosmetic products or topical applied drugs on the study areas at least 12 hours before measurement
* Skin phototype I to III according to Fitzpatrick classification
* Willing and able to fulfil the study requirements

Exclusion Criteria:

* Disability to maintain in supine or prone position
* Acute diseases
* Acute or chronic diseases with increased or decreased body temperature (≤ 35°C or ≥ 38,5°C, measured in the ear)
* History or establishment of Diabetes or pre-diabetes, cardiac or renal insufficiency, atopic dermatitis, psoriasis, chronic obstructive pulmonary disease (COPD)
* Acute or chronic wounds in the skin areas of interest
* Any skin affection which may interfere with the study assessment, e.g. tattoo, psoriasis or scar on the investigational sites
* Participation in another clinical study 4 weeks before inclusion visit
* Current participation in any other clinical study

Primary outcomes:
measure: Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline
timeFrame: at baseline
measure: Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading
timeFrame: after two hours loading
measure: Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading
timeFrame: 20 min after off-loading
measure: Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline
timeFrame: at baseline
measure: Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading
timeFrame: after two hours loading
measure: Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading
timeFrame: 20 min after off-loading
Secondary outcomes:
measure: Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline
timeFrame: at baseline
measure: Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours
timeFrame: after two hours
measure: Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading
timeFrame: 20 minutes after off-loading
measure: Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline
timeFrame: at baseline
measure: Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading
timeFrame: 20 minutes after off-loading
measure: Erythema Index in Arbitrary Units at the Sacrum, at Baseline
timeFrame: at baseline
measure: Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading
timeFrame: after two hours loading
measure: Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading
timeFrame: 20 min after off-loading
measure: Erythema Index in Arbitrary Units at the Heels, at Baseline
timeFrame: at baseline
measure: Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading
timeFrame: after two hours loading
measure: Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading
timeFrame: 20 min after off-loading
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline
timeFrame: at baseline
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading
timeFrame: after two hours loading
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading
timeFrame: 20 min after off-loading
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline
timeFrame: Baseline
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading
timeFrame: after two hours loading
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading
timeFrame: 20 min after off-loading
measure: Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline
timeFrame: Baseline
measure: Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading
timeFrame: 20 min after off-loading
measure: Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline
timeFrame: Baseline
measure: Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading
timeFrame: 20 min after off-loading
measure: Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline
timeFrame: Baseline
measure: Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading
timeFrame: 20 minutes after off-loading
measure: Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline
timeFrame: Baseline
measure: Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading
timeFrame: 20 min after off-loading
measure: Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline
timeFrame: Baseline
measure: Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading
timeFrame: 20 min after off-loading
measure: Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline
timeFrame: Baseline
measure: Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading
timeFrame: 20 minutes after off-loading
measure: Skin Extensibility (Uf) in mm at the Sacrum, at Baseline
timeFrame: Baseline
measure: Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading
timeFrame: 20 minutes after off-loading
measure: Skin Extensibility (Uf) in mm at the Heel, at Baseline
timeFrame: Baseline
measure: Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading
timeFrame: 20 minutes after off-loading
measure: Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline
timeFrame: Baseline
measure: Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading
timeFrame: after two hours loading
measure: Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading
timeFrame: 20 minutes after off-loading
measure: Elastic Recovery (Ur/Uf) at the Heel, at Baseline
timeFrame: Baseline
measure: Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading
timeFrame: after two hours loading
measure: Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading
timeFrame: 20 minutes after off-loading
measure: Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline
timeFrame: Baseline
measure: Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading
timeFrame: 20 minutes after off-loading
measure: Skin Elastic Function (Ur/Ue) at the Heel, at Baseline
timeFrame: Baseline
measure: Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading
timeFrame: 20 minutes after off-loading
measure: Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline
timeFrame: Baseline
measure: Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading
timeFrame: after two hours loading
measure: Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading
timeFrame: 20 minutes after off-loading
measure: Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline
timeFrame: Baseline
measure: Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading
timeFrame: after two hours loading
measure: Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading
timeFrame: 20 minutes after off-loading
measure: Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum
timeFrame: Baseline
measure: Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum
timeFrame: after two hours loading
measure: Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel
timeFrame: baseline
measure: Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel
timeFrame: after two hours loading
measure: Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)
timeFrame: baseline
measure: Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)
timeFrame: after two hours loading
measure: Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline
timeFrame: at baseline
measure: Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline
timeFrame: Baseline
measure: Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
measure: Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline
timeFrame: Baseline
measure: Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline
timeFrame: Baseline
measure: Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
measure: Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline
timeFrame: Baseline
measure: Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline
timeFrame: Baseline
measure: Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline
timeFrame: Baseline
measure: Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline
timeFrame: Baseline
measure: Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline
timeFrame: Baseline
measure: Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
measure: Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline
timeFrame: Baseline
measure: Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
measure: Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline
timeFrame: Baseline
measure: Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading
timeFrame: after two hours loading
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité-Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Jan Kottner, PD Dr.
role: STUDY_DIRECTOR
References:
citation: Tomova-Simitchieva T, Lichterfeld-Kottner A, Blume-Peytavi U, Kottner J. Comparing the effects of 3 different pressure ulcer prevention support surfaces on the structure and function of heel and sacral skin: An exploratory cross-over trial. Int Wound J. 2018 Jun;15(3):429-437. doi: 10.1111/iwj.12883. Epub 2017 Dec 26.