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Effects of Different Support Surfaces on the Properties Skin After Loading

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02930590
Enrollment
15
Registered
2016-10-12
Start date
2016-09-30
Completion date
2017-03-31
Last updated
2022-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pressure Ulcers

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).

Interventions

OTHERAlternating low pressure mattress with air loss function

IsoAir, Stryker, USA

OTHERGel mattress

IsoGel, Stryker, USA

OTHERBasic foam

Standard hospital mattress

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
60 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baselineat baselineTEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loadingafter two hours loadingTEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading20 min after off-loadingTEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baselineat baselineTEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loadingafter two hours loadingTEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading20 min after off-loadingTEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).

Secondary

MeasureTime frameDescription
Erythema Index in Arbitrary Units at the Sacrum, at Baselineat baselineErythema 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.
Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loadingafter two hours loadingErythema 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.
Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading20 min after off-loadingErythema 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.
Erythema Index in Arbitrary Units at the Heels, at Baselineat baselineErythema 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.
Erythema Index in Arbitrary Units at the Heels, After Two Hours Loadingafter two hours loadingErythema 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.
Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading20 min after off-loadingErythema 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.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baselineat baselineCorneometer® 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.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loadingafter two hours loadingCorneometer® 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.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading20 min after off-loadingCorneometer® 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.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at BaselineBaselineCorneometer® 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.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loadingafter two hours loadingCorneometer® 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.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading20 min after off-loadingCorneometer® 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.
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at BaselineBaselineSkin 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.
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loadingafter two hours loadingSkin 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.
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading20 min after off-loadingSkin 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.
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at BaselineBaselineSkin 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.
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loadingafter two hours loadingSkin 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.
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading20 min after off-loadingSkin 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.
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at BaselineBaselineSkin 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.
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loadingafter two hours loadingSkin 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.
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading20 minutes after off-loadingSkin 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.
Skin Surface Mean Roughness (Rz) in μm at the Heel, at BaselineBaselineSkin 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.
Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loadingafter two hours loadingSkin 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.
Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading20 min after off-loadingSkin 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.
Skin Surface Mean Roughness (Ra) in μm at the Heels, at BaselineBaselineSkin 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.
Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loadingafter two hours loadingSkin 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.
Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading20 min after off-loadingSkin 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.
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loadingafter two hours loadingSkin 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.
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at BaselineBaselineSkin 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.
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading20 minutes after off-loadingSkin 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.
Skin Extensibility (Uf) in mm at the Sacrum, at BaselineBaselineSkin 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).
Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loadingafter two hours loadingSkin 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).
Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading20 minutes after off-loadingSkin 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).
Skin Extensibility (Uf) in mm at the Heel, at BaselineBaselineSkin 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).
Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loadingafter two hours loadingSkin 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).
Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading20 minutes after off-loadingSkin 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).
Elastic Recovery (Ur/Uf) at the Sacrum, at BaselineBaselineThe 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.
Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loadingafter two hours loadingThe 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.
Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading20 minutes after off-loadingThe 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.
Elastic Recovery (Ur/Uf) at the Heel, at BaselineBaselineThe 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.
Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loadingafter two hours loadingThe 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.
Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading20 minutes after off-loadingThe 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.
Skin Elastic Function (Ur/Ue) at the Sacrum, at BaselineBaselineThe 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.
Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loadingafter two hours loadingThe 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.
Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading20 minutes after off-loadingThe 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.
Skin Elastic Function (Ur/Ue) at the Heel, at BaselineBaselineThe 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.
Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loadingafter two hours loadingThe 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.
Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading20 minutes after off-loadingThe 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.
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at BaselineBaselineEpidermal 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 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loadingafter two hours loadingEpidermal 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 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading20 minutes after off-loadingEpidermal 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 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at BaselineBaselineEpidermal 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 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loadingafter two hours loadingEpidermal 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 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading20 minutes after off-loadingEpidermal 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 %).
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the SacrumBaselineSkin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the HeelbaselineSkin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)baselineSkin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baselineat baselineTEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany)
Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loadingafter two hours loadingTEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at BaselineBaselineSkin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loadingafter two hours loadingSkin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Erythema Index in Arbitrary Units at the Sternum (Control- Area), at BaselineBaselineErythema 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.
Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loadingafter two hours loadingErythema 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.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at BaselineBaselineCorneometer® 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.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loadingafter two hours loadingCorneometer® 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.
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at BaselineBaselineEpidermal 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 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loadingafter two hours loadingEpidermal 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 %).
Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at BaselineBaselineSkin 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.
Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loadingafter two hours loadingSkin 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.
Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at BaselineBaselineSkin 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.
Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loadingafter two hours loadingSkin 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.
Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at BaselineBaselineSkin 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.
Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loadingafter two hours loadingSkin 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.
Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baselineat baselineSkin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loadingafter two hours loadingSkin 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).
Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at BaselineBaselineThe 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.
Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loadingafter two hours loadingThe 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.
Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at BaselineBaselineThe 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.
Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loadingafter two hours loadingThe 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.
Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at BaselineBaselineSkin 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).
Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hoursafter two hoursSkin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading20 minutes after off-loadingSkin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Heel, at Baselineat baselineSkin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loadingafter two hours loadingSkin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading20 minutes after off-loadingSkin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.

Countries

Germany

Participant flow

Recruitment details

The study took place at the Clinical Research Center for Hair and Skin Science in Berlin, Germany from September 2016 to March 2017 and involved 15 healthy female volunteers.

Participants by arm

ArmCount
AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam
Cross-over trial. In total 15 participants, each of them lied on every of the three types of mattress.
15
Total15

Baseline characteristics

CharacteristicAlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam
Age, Continuous66 years
Body Mass Index (BMI)24.5 kg/m2
Body temperature36.3 °C
Diastolic blood pressure75 mmHg
Heart rate78 beats per minute
Race and Ethnicity Not Collected— Participants
Region of Enrollment
Germany
15 participants
Sex: Female, Male
Female
15 Participants
Sex: Female, Male
Male
0 Participants
Skin phototype
Skin phototype I
3 Participants
Skin phototype
Skin phototype II
9 Participants
Skin phototype
Skin phototype III
3 Participants
Systolic blood pressure125 mmHg

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 150 / 15
other
Total, other adverse events
0 / 150 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 150 / 15

Outcome results

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).

Time frame: 20 min after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressTransepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading9.6 g/m2/h
Reactive Support SurfaceTransepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading10.4 g/m2/h
Standard MattressTransepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading11.1 g/m2/h
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).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressTransepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading19.5 g/m2/h
Reactive Support SurfaceTransepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading19.2 g/m2/h
Standard MattressTransepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading28.4 g/m2/h
Primary

Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline

TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).

Time frame: at baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressTransepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline8.1 g/m2/h
Reactive Support SurfaceTransepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline9.4 g/m2/h
Standard MattressTransepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline8.6 g/m2/h
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).

Time frame: 20 min after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressTransepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading8.0 g/m2/h
Reactive Support SurfaceTransepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading7.6 g/m2/h
Standard MattressTransepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading8.0 g/m2/h
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).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressTransepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading12.4 g/m2/h
Reactive Support SurfaceTransepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading10.4 g/m2/h
Standard MattressTransepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading14.5 g/m2/h
Primary

Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline

TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).

Time frame: at baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressTransepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline7.8 g/m2/h
Reactive Support SurfaceTransepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline7.7 g/m2/h
Standard MattressTransepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline7.1 g/m2/h
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.

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressElastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading0.34 proportion of the elastic recovery
Reactive Support SurfaceElastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading0.36 proportion of the elastic recovery
Standard MattressElastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading0.35 proportion of the elastic recovery
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressElastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading0.35 proportion of the elastic recovery
Reactive Support SurfaceElastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading0.36 proportion of the elastic recovery
Standard MattressElastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading0.38 proportion of the elastic recovery
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressElastic Recovery (Ur/Uf) at the Heel, at Baseline0.36 proportion of the elastic recovery
Reactive Support SurfaceElastic Recovery (Ur/Uf) at the Heel, at Baseline0.35 proportion of the elastic recovery
Standard MattressElastic Recovery (Ur/Uf) at the Heel, at Baseline0.35 proportion of the elastic recovery
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.

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressElastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading0.52 proportion of the elastic recovery
Reactive Support SurfaceElastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading0.45 proportion of the elastic recovery
Standard MattressElastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading0.51 proportion of the elastic recovery
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressElastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading0.55 proportion of the elastic recovery
Reactive Support SurfaceElastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading0.50 proportion of the elastic recovery
Standard MattressElastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading0.44 proportion of the elastic recovery
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressElastic Recovery (Ur/Uf) at the Sacrum, at Baseline0.55 proportion of the elastic recovery
Reactive Support SurfaceElastic Recovery (Ur/Uf) at the Sacrum, at Baseline0.52 proportion of the elastic recovery
Standard MattressElastic Recovery (Ur/Uf) at the Sacrum, at Baseline0.57 proportion of the elastic recovery
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lay on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressElastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading0.47 proportion of the elastic recovery
Reactive Support SurfaceElastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading0.48 proportion of the elastic recovery
Standard MattressElastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading0.43 proportion of the elastic recovery
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lay on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressElastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline0.42 proportion of the elastic recovery
Reactive Support SurfaceElastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline0.43 proportion of the elastic recovery
Standard MattressElastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline0.47 proportion of the elastic recovery
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 %).

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading25.5 percentage of tissue water content
Reactive Support SurfaceEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading25.5 percentage of tissue water content
Standard MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading25.5 percentage of tissue water content
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 %).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading28.0 percentage of tissue water content
Reactive Support SurfaceEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading25.5 percentage of tissue water content
Standard MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading28.0 percentage of tissue water content
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 %).

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline25.5 percentage of tissue water content
Reactive Support SurfaceEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline25.5 percentage of tissue water content
Standard MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline24.0 percentage of tissue water content
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 %).

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading44.5 percentage of tissue water content
Reactive Support SurfaceEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading42.5 percentage of tissue water content
Standard MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading44.0 percentage of tissue water content
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 %).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading44.5 percentage of tissue water content
Reactive Support SurfaceEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading41.5 percentage of tissue water content
Standard MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading43.5 percentage of tissue water content
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 %).

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline41.0 percentage of tissue water content
Reactive Support SurfaceEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline40.0 percentage of tissue water content
Standard MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline41.0 percentage of tissue water content
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 %).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading45.5 percentage of tissue water content
Reactive Support SurfaceEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading51.5 percentage of tissue water content
Standard MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading51.5 percentage of tissue water content
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 %).

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline50.0 percentage of tissue water content
Reactive Support SurfaceEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline52.0 percentage of tissue water content
Standard MattressEpidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline51.5 percentage of tissue water content
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).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel0.45 µm
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).

Time frame: baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel0.43 µm
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).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum0.08 µm
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).

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum0.09 µm
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).

Time frame: baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)0.08 µm
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).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressEpidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)0.08 µm
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 (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.

Time frame: 20 min after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressErythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading231.9 arbitrary units
Reactive Support SurfaceErythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading188.5 arbitrary units
Standard MattressErythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading226.7 arbitrary units
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 (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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressErythema Index in Arbitrary Units at the Heels, After Two Hours Loading247.1 arbitrary units
Reactive Support SurfaceErythema Index in Arbitrary Units at the Heels, After Two Hours Loading225.7 arbitrary units
Standard MattressErythema Index in Arbitrary Units at the Heels, After Two Hours Loading225.2 arbitrary units
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 (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.

Time frame: at baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressErythema Index in Arbitrary Units at the Heels, at Baseline194.5 arbitrary units
Reactive Support SurfaceErythema Index in Arbitrary Units at the Heels, at Baseline177.9 arbitrary units
Standard MattressErythema Index in Arbitrary Units at the Heels, at Baseline186.2 arbitrary units
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 (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.

Time frame: 20 min after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressErythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading201.3 arbitrary units
Reactive Support SurfaceErythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading194.0 arbitrary units
Standard MattressErythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading221.0 arbitrary units
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 (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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressErythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading220.2 arbitrary units
Reactive Support SurfaceErythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading206.0 arbitrary units
Standard MattressErythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading235.9 arbitrary units
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 (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.

Time frame: at baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressErythema Index in Arbitrary Units at the Sacrum, at Baseline187.5 arbitrary units
Reactive Support SurfaceErythema Index in Arbitrary Units at the Sacrum, at Baseline176.5 arbitrary units
Standard MattressErythema Index in Arbitrary Units at the Sacrum, at Baseline167.2 arbitrary units
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 (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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressErythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading344.2 arbitrary units
Reactive Support SurfaceErythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading350.2 arbitrary units
Standard MattressErythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading325.9 arbitrary units
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 (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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressErythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline317.7 arbitrary units
Reactive Support SurfaceErythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline342 arbitrary units
Standard MattressErythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline390.2 arbitrary units
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.

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading0.67 percentage of net elasticity
Reactive Support SurfaceSkin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading0.67 percentage of net elasticity
Standard MattressSkin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading0.67 percentage of net elasticity
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading0.66 percentage of net elasticity
Reactive Support SurfaceSkin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading0.70 percentage of net elasticity
Standard MattressSkin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading0.70 percentage of net elasticity
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Elastic Function (Ur/Ue) at the Heel, at Baseline0.67 percentage of net elasticity
Reactive Support SurfaceSkin Elastic Function (Ur/Ue) at the Heel, at Baseline0.68 percentage of net elasticity
Standard MattressSkin Elastic Function (Ur/Ue) at the Heel, at Baseline0.68 percentage of net elasticity
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.

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading0.75 percentage of net elasticity
Reactive Support SurfaceSkin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading0.66 percentage of net elasticity
Standard MattressSkin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading0.72 percentage of net elasticity
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading0.81 percentage of net elasticity
Reactive Support SurfaceSkin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading0.70 percentage of net elasticity
Standard MattressSkin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading0.65 percentage of net elasticity
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Elastic Function (Ur/Ue) at the Sacrum, at Baseline0.79 percentage of net elasticity
Reactive Support SurfaceSkin Elastic Function (Ur/Ue) at the Sacrum, at Baseline0.78 percentage of net elasticity
Standard MattressSkin Elastic Function (Ur/Ue) at the Sacrum, at Baseline0.80 percentage of net elasticity
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading0.71 percentage of net elasticity
Reactive Support SurfaceSkin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading0.32 percentage of net elasticity
Standard MattressSkin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading0.68 percentage of net elasticity
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline0.59 percentage of net elasticity
Reactive Support SurfaceSkin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline0.32 percentage of net elasticity
Standard MattressSkin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline0.70 percentage of net elasticity
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).

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading0.08 mm
Reactive Support SurfaceSkin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading0.09 mm
Standard MattressSkin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading0.10 mm
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).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Extensibility (Uf) in mm at the Heel, After Two Hours Loading0.10 mm
Reactive Support SurfaceSkin Extensibility (Uf) in mm at the Heel, After Two Hours Loading0.10 mm
Standard MattressSkin Extensibility (Uf) in mm at the Heel, After Two Hours Loading0.10 mm
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).

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Extensibility (Uf) in mm at the Heel, at Baseline0.08 mm
Reactive Support SurfaceSkin Extensibility (Uf) in mm at the Heel, at Baseline0.08 mm
Standard MattressSkin Extensibility (Uf) in mm at the Heel, at Baseline0.09 mm
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).

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading0.33 mm
Reactive Support SurfaceSkin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading0.31 mm
Standard MattressSkin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading0.32 mm
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).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading0.34 mm
Reactive Support SurfaceSkin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading0.32 mm
Standard MattressSkin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading0.35 mm
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).

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Extensibility (Uf) in mm at the Sacrum, at Baseline0.32 mm
Reactive Support SurfaceSkin Extensibility (Uf) in mm at the Sacrum, at Baseline0.29 mm
Standard MattressSkin Extensibility (Uf) in mm at the Sacrum, at Baseline0.32 mm
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).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading0.32 mm
Reactive Support SurfaceSkin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading0.32 mm
Standard MattressSkin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading0.37 mm
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).

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline0.34 mm
Reactive Support SurfaceSkin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline0.32 mm
Standard MattressSkin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline0.36 mm
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.

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading71.5 µm
Reactive Support SurfaceSkin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading81.5 µm
Standard MattressSkin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading70.0 µm
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading67.5 µm
Reactive Support SurfaceSkin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading73.5 µm
Standard MattressSkin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading67.5 µm
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline63.5 µm
Reactive Support SurfaceSkin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline63.8 µm
Standard MattressSkin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline70.0 µm
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.

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading57.0 µm
Reactive Support SurfaceSkin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading52.5 µm
Standard MattressSkin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading52.0 µm
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading51.0 µm
Reactive Support SurfaceSkin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading50.0 µm
Standard MattressSkin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading52.0 µm
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline51.0 µm
Reactive Support SurfaceSkin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline47.5 µm
Standard MattressSkin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline46.5 µm
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading38.5 µm
Reactive Support SurfaceSkin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading38.5 µm
Standard MattressSkin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading36.0 µm
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline48.5 µm
Reactive Support SurfaceSkin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline49.0 µm
Standard MattressSkin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline44.5 µm
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.

Time frame: 20 min after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading10.5 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading11.5 µm
Standard MattressSkin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading9.0 µm
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading10.0 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading10.0 µm
Standard MattressSkin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading8.5 µm
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline9.0 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline9.8 µm
Standard MattressSkin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline9.5 µm
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.

Time frame: 20 min after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading10.0 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading9.5 µm
Standard MattressSkin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading9.0 µm
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading9.0 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading9.0 µm
Standard MattressSkin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading8.5 µm
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline9.0 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline8.3 µm
Standard MattressSkin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline8.0 µm
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading7.0 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading7.0 µm
Standard MattressSkin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading7.0 µm
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline8.0 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline7.3 µm
Standard MattressSkin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline8.5 µm
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline48.5 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline48.3 µm
Standard MattressSkin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline51.5 µm
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.

Time frame: 20 min after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading52.5 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading59.5 µm
Standard MattressSkin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading55.0 µm
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading50.5 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading51.5 µm
Standard MattressSkin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading51.0 µm
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.

Time frame: 20 min after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading43.0 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading40.5 µm
Standard MattressSkin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading42.5 µm
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading39.0 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading40.0 µm
Standard MattressSkin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading39.5 µm
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline39.5 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline35.5 µm
Standard MattressSkin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline34.0 µm
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading29.0 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading28.5 µm
Standard MattressSkin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading28.0 µm
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline36.5 µm
Reactive Support SurfaceSkin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline37.8 µm
Standard MattressSkin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline35.0 µm
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.

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading25.4 °C
Reactive Support SurfaceSkin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading25.2 °C
Standard MattressSkin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading25.9 °C
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading26.5 °C
Reactive Support SurfaceSkin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading25.5 °C
Standard MattressSkin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading26.6 °C
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.

Time frame: at baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Temperature in °C Per Skin Area at the Heel, at Baseline24.4 °C
Reactive Support SurfaceSkin Surface Temperature in °C Per Skin Area at the Heel, at Baseline25.2 °C
Standard MattressSkin Surface Temperature in °C Per Skin Area at the Heel, at Baseline24.3 °C
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.

Time frame: 20 minutes after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading30.3 °C
Reactive Support SurfaceSkin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading29.4 °C
Standard MattressSkin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading30.3 °C
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.

Time frame: after two hours

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours31.4 °C
Reactive Support SurfaceSkin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours30.7 °C
Standard MattressSkin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours32.0 °C
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.

Time frame: at baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline28.8 °C
Reactive Support SurfaceSkin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline28.9 °C
Standard MattressSkin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline29.1 °C
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading29.9 °C
Reactive Support SurfaceSkin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading30.2 °C
Standard MattressSkin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading30.6 °C
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressSkin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline30.8 °C
Reactive Support SurfaceSkin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline30.7 °C
Standard MattressSkin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline30.9 °C
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.

Time frame: 20 min after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading14.4 arbitrary units
Reactive Support SurfaceStratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading12.9 arbitrary units
Standard MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading15.3 arbitrary units
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading18.0 arbitrary units
Reactive Support SurfaceStratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading17.9 arbitrary units
Standard MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading20.2 arbitrary units
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline13.3 arbitrary units
Reactive Support SurfaceStratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline13.6 arbitrary units
Standard MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline12.9 arbitrary units
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.

Time frame: 20 min after off-loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading29.3 arbitrary units
Reactive Support SurfaceStratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading27.4 arbitrary units
Standard MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading30.1 arbitrary units
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading34.6 arbitrary units
Reactive Support SurfaceStratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading29.8 arbitrary units
Standard MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading31.6 arbitrary units
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.

Time frame: at baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline27.2 arbitrary units
Reactive Support SurfaceStratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline23.8 arbitrary units
Standard MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline27.5 arbitrary units
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.

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading46.7 arbitrary units
Reactive Support SurfaceStratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading43.7 arbitrary units
Standard MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading44.3 arbitrary units
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.

Time frame: Baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline48.1 arbitrary units
Reactive Support SurfaceStratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline50.0 arbitrary units
Standard MattressStratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline47.0 arbitrary units
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).

Time frame: after two hours loading

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressTransepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading8.3 g/m2/h
Reactive Support SurfaceTransepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading8.0 g/m2/h
Standard MattressTransepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading8.1 g/m2/h
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)

Time frame: at baseline

Population: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.

ArmMeasureValue (MEDIAN)
Alternating Low Pressure MattressTransepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline10.4 g/m2/h
Reactive Support SurfaceTransepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline9.8 g/m2/h
Standard MattressTransepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline9.8 g/m2/h

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026