Effects of Different Support Surfaces on the Properties Skin After Loading

Pressure Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02930590
• Other study ID #: CRC-PU-A-23
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2017

Study information

• Verified date: May 2022
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Pressure Ulcer
• Pressure Ulcers

Intervention

Other:
• Alternating low pressure mattress with air loss function
IsoAir, Stryker, USA
• Gel mattress
IsoGel, Stryker, USA
• Basic foam
Standard hospital mattress

Locations

Country	Name	City	State
Germany	Charité-Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 (? = 660 nm) and green (? = 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
Secondary	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 (? = 660 nm) and green (? = 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
Secondary	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 (? = 660 nm) and green (? = 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
Secondary	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 (? = 660 nm) and green (? = 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
Secondary	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 (? = 660 nm) and green (? = 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
Secondary	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 (? = 660 nm) and green (? = 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 (? = 660 nm) and green (? = 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
Secondary	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 (? = 660 nm) and green (? = 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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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