Effects of Different Support Surfaces on the Properties Skin After Loading

Study Overview
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Brief Summary
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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).

Official Title
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Comparing the Effects of Three Different Support Surfaces on the Properties of Heel and Sacral Skin After Loading

Conditions
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Pressure Ulcers

Intervention / Treatment
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* Other: Alternating low pressure mattress with air loss function
* Other: Gel mattress
* Other: Basic foam


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Pressure mattress<br>Alternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA) | Other: Alternating low pressure mattress with air loss function<br>* IsoAir, Stryker, USA<br>|
| Experimental: Reactive support surface<br>Gel mattress (IsoGel, stryker, USA) | Other: Gel mattress<br>* IsoGel, Stryker, USA<br>|
| Active Comparator: Standard mattress<br>basic foam | Other: Basic foam<br>* Standard hospital mattress<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | at baseline | 
| Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | after two hours loading | 
| Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | 20 min after off-loading | 
| Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | at baseline | 
| Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | after two hours loading | 
| Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | 20 min after off-loading | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | at baseline | 
| Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | after two hours | 
| Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | 20 minutes after off-loading | 
| Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | at baseline | 
| Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | after two hours loading | 
| Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | 20 minutes after off-loading | 
| Erythema Index in Arbitrary Units at the Sacrum, at Baseline | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | at baseline | 
| Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | after two hours loading | 
| Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | 20 min after off-loading | 
| Erythema Index in Arbitrary Units at the Heels, at Baseline | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | at baseline | 
| Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | after two hours loading | 
| Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | 20 min after off-loading | 
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | at baseline | 
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | after two hours loading | 
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer. | 20 min after off-loading | 
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer. | Baseline | 
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | after two hours loading | 
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | 20 min after off-loading | 
| Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | Baseline | 
| Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | after two hours loading | 
| Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | 20 min after off-loading | 
| Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | Baseline | 
| Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | after two hours loading | 
| Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | 20 min after off-loading | 
| Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | Baseline | 
| Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | after two hours loading | 
| Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | 20 minutes after off-loading | 
| Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | Baseline | 
| Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | after two hours loading | 
| Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | 20 min after off-loading | 
| Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | Baseline | 
| Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | after two hours loading | 
| Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | 20 min after off-loading | 
| Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | after two hours loading | 
| Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | Baseline | 
| Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | 20 minutes after off-loading | 
| Skin Extensibility (Uf) in mm at the Sacrum, at Baseline | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted with a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | Baseline | 
| Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm(Uf, mm). | after two hours loading | 
| Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the Skin in mm (Uf, mm). | 20 minutes after off-loading | 
| Skin Extensibility (Uf) in mm at the Heel, at Baseline | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | Baseline | 
| Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | after two hours loading | 
| Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | 20 minutes after off-loading | 
| Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline | 
| Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading | 
| Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | 20 minutes after off-loading | 
| Elastic Recovery (Ur/Uf) at the Heel, at Baseline | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline | 
| Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading | 
| Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | 20 minutes after off-loading | 
| Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline | 
| Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading | 
| Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | 20 minutes after off-loading | 
| Skin Elastic Function (Ur/Ue) at the Heel, at Baseline | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline | 
| Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading | 
| Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | 20 minutes after off-loading | 
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | Baseline | 
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | after two hours loading | 
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | 20 minutes after off-loading | 
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | Baseline | 
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | after two hours loading | 
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | 20 minutes after off-loading | 
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | Baseline | 
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | after two hours loading | 
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | baseline | 
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | after two hours loading | 
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area) | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | baseline | 
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area) | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | after two hours loading | 
| Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline | TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany) | at baseline | 
| Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading | TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | after two hours loading | 
| Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | Baseline | 
| Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | after two hours loading | 
| Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | Baseline | 
| Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | after two hours loading | 
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | Baseline | 
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | after two hours loading | 
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | Baseline | 
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | after two hours loading | 
| Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | Baseline | 
| Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | after two hours loading | 
| Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | Baseline | 
| Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | after two hours loading | 
| Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | Baseline | 
| Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | after two hours loading | 
| Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | Baseline | 
| Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | after two hours loading | 
| Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline | 
| Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading | 
| Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline | 
| Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading |