An interventional study of Alternating low pressure mattress with air loss function and Gel mattress in Pressure Ulcers, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to female participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-14.
Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Supportive care
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).
518 studies on the registry are indexed under Pressure Ulcer; 117 are open to participants now.
This study's enrollment of 15 is below the median of 70 across 395 interventional studies indexed under Pressure Ulcer.
Browse Pressure Ulcer studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Alternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA)
Other: Alternating low pressure mattress with air loss function
Gel mattress (IsoGel, stryker, USA)
Other: Gel mattress
basic foam
Other: Basic foam
IsoAir, Stryker, USA
IsoGel, Stryker, USA
Standard hospital mattress
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
| Milestone | Low Pressure, Reactive Support, Than Standard Mattress | Low Pressure, Standard Mattress, Than Reactive Support | Reactive Support, Low Pressure, Than Standard Mattress | Reactive Support, Standard Mattress, Than Low Pressure | Standard Mattress, Low Pressure, Than Reactive Support | Standard Mattress, Reactive Support, Than Low Pressure |
|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 2 | 2 | 2 |
| Completed | 3 | 3 | 3 | 2 | 2 | 2 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Low Pressure, Reactive Support, Than Standard Mattress | Low Pressure, Standard Mattress, Than Reactive Support | Reactive Support, Low Pressure, Than Standard Mattress | Reactive Support, Standard Mattress, Than Low Pressure | Standard Mattress, Low Pressure, Than Reactive Support | Standard Mattress, Reactive Support, Than Low Pressure |
|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 2 | 2 | 2 |
| Completed | 3 | 3 | 3 | 2 | 2 | 2 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Low Pressure, Reactive Support, Than Standard Mattress | Low Pressure, Standard Mattress, Than Reactive Support | Reactive Support, Low Pressure, Than Standard Mattress | Reactive Support, Standard Mattress, Than Low Pressure | Standard Mattress, Low Pressure, Than Reactive Support | Standard Mattress, Reactive Support, Than Low Pressure |
|---|---|---|---|---|---|---|
| Started | 3 | 3 | 3 | 2 | 2 | 2 |
| Completed | 3 | 3 | 3 | 2 | 2 | 2 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
| g/m2/h | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline | 7.8 (6.7 to 8.8) | 7.7 (6.7 to 8.2) | 7.1 (6.8 to 8.8) |
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
| g/m2/h | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading | 12.4 (11.5 to 15.2) | 10.4 (8.5 to 12.2) | 14.5 (9.3 to 20.5) |
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
| g/m2/h | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading | 8.0 (7.0 to 8.6) | 7.6 (6.4 to 8.6) | 8.0 (6.8 to 9.0) |
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
| g/m2/h | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline | 8.1 (7.6 to 10.9) | 9.4 (8.2 to 11.6) | 8.6 (7.4 to 12.1) |
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
| g/m2/h | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading | 19.5 (16.6 to 25.3) | 19.2 (16.3 to 23.3) | 28.4 (15.9 to 32.3) |
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
| g/m2/h | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading | 9.6 (9.0 to 11.2) | 10.4 (8.9 to 13.3) | 11.1 (9.9 to 14.8) |
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
| °C | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline | 28.8 (28.2 to 29.2) | 28.9 (28.3 to 29.2) | 29.1 (28.1 to 29.8) |
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
| °C | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours | 31.4 (31.3 to 32.0) | 30.7 (30.5 to 31.3) | 32.0 (31.3 to 32.2) |
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
| °C | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading | 30.3 (29.8 to 30.6) | 29.4 (29.2 to 30.1) | 30.3 (29.8 to 31.1) |
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
| °C | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline | 24.4 (24.1 to 25.2) | 25.2 (24.3 to 25.4) | 24.3 (23.3 to 25.4) |
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
| °C | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading | 26.5 (25.4 to 26.9) | 25.5 (24.7 to 26.2) | 26.6 (25.5 to 27.3) |
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
| °C | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading | 25.4 (24.9 to 26.0) | 25.2 (23.8 to 25.4) | 25.9 (24.9 to 26.6) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Erythema Index in Arbitrary Units at the Sacrum, at Baseline | 187.5 (164.4 to 224.3) | 176.5 (142.7 to 211.1) | 167.2 (150.5 to 193.7) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading | 220.2 (185.0 to 251.4) | 206.0 (153.2 to 238.5) | 235.9 (191.3 to 275.2) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading | 201.3 (177.8 to 233.5) | 194.0 (147.0 to 218.5) | 221.0 (191.4 to 239.9) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Erythema Index in Arbitrary Units at the Heels, at Baseline | 194.5 (132.2 to 225.4) | 177.9 (143.2 to 250.9) | 186.2 (116.7 to 234.7) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading | 247.1 (146.9 to 279.2) | 225.7 (160.0 to 272.5) | 225.2 (183.5 to 290.5) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading | 231.9 (145.9 to 246.0) | 188.5 (142.8 to 236.0) | 226.7 (143.7 to 246.9) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline | 27.2 (19.7 to 34.7) | 23.8 (19.5 to 35.8) | 27.5 (25.1 to 36.2) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading | 34.6 (25.3 to 40.4) | 29.8 (22.0 to 40.0) | 31.6 (26.1 to 42.5) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading | 29.3 (25.6 to 35.9) | 27.4 (22.7 to 36.4) | 30.1 (23.9 to 39.6) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline | 13.3 (8.3 to 19.2) | 13.6 (9.3 to 21.1) | 12.9 (8.7 to 17.8) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading | 18.0 (13.9 to 23.4) | 17.9 (12.5 to 23.4) | 20.2 (14.5 to 24.6) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading | 14.4 (10.7 to 22.1) | 12.9 (8.3 to 19.2) | 15.3 (10.8 to 17.8) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline | 39.5 (33.5 to 41.0) | 35.5 (33.3 to 44.6) | 34.0 (32.0 to 41.5) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading | 39.0 (36.0 to 43.5) | 40.0 (37.0 to 43.5) | 39.5 (34.0 to 44.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading | 43.0 (38.5 to 50.5) | 40.5 (36.0 to 49.0) | 42.5 (37.0 to 46.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline | 9.0 (8.0 to 10.0) | 8.3 (6.9 to 10.1) | 8.0 (7.5 to 10.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading | 9.0 (8.0 to 11.5) | 9.0 (8.5 to 10.0) | 8.5 (7.5 to 10.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading | 10.0 (8.5 to 12.0) | 9.5 (8.5 to 10.0) | 9.0 (8.0 to 11.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline | 51.0 (42.5 to 56.0) | 47.5 (42.8 to 57.0) | 46.5 (38.5 to 53.5) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading | 51.0 (45.5 to 59.0) | 50.0 (46.0 to 57.5) | 52.0 (43.5 to 58.5) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading | 57.0 (49.5 to 63.5) | 52.5 (45.5 to 65.0) | 52.0 (47.5 to 61.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline | 48.5 (32.0 to 68.0) | 48.3 (36.1 to 59.4) | 51.5 (34.5 to 72.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading | 50.5 (43.5 to 63.5) | 51.5 (45.0 to 72.0) | 51.0 (39.5 to 70.5) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading | 52.5 (46.0 to 73.0) | 59.5 (53.0 to 88.0) | 55.0 (40.0 to 58.5) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline | 9.0 (7.5 to 13.5) | 9.8 (7.9 to 12.0) | 9.5 (7.0 to 15.5) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading | 10.0 (7.5 to 12.0) | 10.0 (9.0 to 12.0) | 8.5 (7.5 to 13.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading | 10.5 (8.5 to 14.0) | 11.5 (9.5 to 17.0) | 9.0 (8.0 to 11.5) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading | 67.5 (59.0 to 83.0) | 73.5 (57.0 to 100.5) | 67.5 (52.0 to 93.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline | 63.5 (44.0 to 93.0) | 63.8 (46.6 to 79.5) | 70.0 (44.5 to 91.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading | 71.5 (61.5 to 94.5) | 81.5 (69.0 to 110.5) | 70.0 (54.0 to 81.5) |
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).
| mm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Extensibility (Uf) in mm at the Sacrum, at Baseline | 0.32 (0.31 to 0.35) | 0.29 (0.26 to 0.33) | 0.32 (0.28 to 0.34) |
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).
| mm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading | 0.34 (0.32 to 0.40) | 0.32 (0.28 to 0.37) | 0.35 (0.32 to 0.37) |
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).
| mm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading | 0.33 (0.30 to 0.38) | 0.31 (0.27 to 0.35) | 0.32 (0.30 to 0.37) |
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).
| mm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Extensibility (Uf) in mm at the Heel, at Baseline | 0.08 (0.07 to 0.12) | 0.08 (0.06 to 0.10) | 0.09 (0.08 to 0.10) |
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).
| mm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading | 0.10 (0.08 to 0.12) | 0.10 (0.10 to 0.12) | 0.10 (0.08 to 0.12) |
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).
| mm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading | 0.08 (0.07 to 0.12) | 0.09 (0.06 to 0.11) | 0.10 (0.08 to 0.12) |
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.
| proportion of the elastic recovery | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline | 0.55 (0.42 to 0.64) | 0.52 (0.46 to 0.64) | 0.57 (0.43 to 0.66) |
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.
| proportion of the elastic recovery | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading | 0.55 (0.42 to 0.65) | 0.50 (0.42 to 0.66) | 0.44 (0.42 to 0.64) |
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.
| proportion of the elastic recovery | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading | 0.52 (0.41 to 0.68) | 0.45 (0.37 to 0.66) | 0.51 (0.44 to 0.64) |
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.
| proportion of the elastic recovery | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Elastic Recovery (Ur/Uf) at the Heel, at Baseline | 0.36 (0.32 to 0.42) | 0.35 (0.33 to 0.39) | 0.35 (0.33 to 0.43) |
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.
| proportion of the elastic recovery | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading | 0.35 (0.30 to 0.37) | 0.36 (0.32 to 0.40) | 0.38 (0.32 to 0.42) |
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.
| proportion of the elastic recovery | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading | 0.34 (0.32 to 0.38) | 0.36 (0.33 to 0.38) | 0.35 (0.32 to 0.37) |
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.
| percentage of net elasticity | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline | 0.79 (0.54 to 0.90) | 0.78 (0.65 to 0.96) | 0.80 (0.67 to 0.97) |
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.
| percentage of net elasticity | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading | 0.81 (0.65 to 0.87) | 0.70 (0.63 to 0.93) | 0.65 (0.56 to 0.90) |
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.
| percentage of net elasticity | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading | 0.75 (0.56 to 0.92) | 0.66 (0.57 to 0.97) | 0.72 (0.59 to 0.80) |
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.
| percentage of net elasticity | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Elastic Function (Ur/Ue) at the Heel, at Baseline | 0.67 (0.64 to 0.77) | 0.68 (0.63 to 0.98) | 0.68 (0.62 to 0.85) |
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.
| percentage of net elasticity | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading | 0.66 (0.58 to 0.79) | 0.70 (0.62 to 0.83) | 0.70 (0.62 to 0.81) |
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.
| percentage of net elasticity | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading | 0.67 (0.61 to 0.79) | 0.67 (0.64 to 0.74) | 0.67 (0.61 to 0.75) |
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 %).
| percentage of tissue water content | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline | 41.0 (39.6 to 43.6) | 40.0 (36.5 to 42.0) | 41.0 (39.0 to 47.0) |
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 %).
| percentage of tissue water content | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading | 44.5 (42.5 to 48.5) | 41.5 (40.5 to 47.5) | 43.5 (41.0 to 49.5) |
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 %).
| percentage of tissue water content | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading | 44.5 (43.0 to 46.0) | 42.5 (39.5 to 46.5) | 44.0 (41.0 to 48.0) |
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 %).
| percentage of tissue water content | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline | 25.5 (21.5 to 29.0) | 25.5 (21.5 to 30.0) | 24.0 (21.5 to 27.5) |
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 %).
| percentage of tissue water content | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading | 28.0 (25.0 to 32.0) | 25.5 (25.0 to 27.5) | 28.0 (27.0 to 31.5) |
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 %).
| percentage of tissue water content | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading | 25.5 (22.5 to 30.0) | 25.5 (23.5 to 28.0) | 25.5 (23.5 to 28.5) |
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
| µm | Standard Mattress |
|---|---|
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum | 0.09 (0.08 to 0.12) |
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
| µm | Standard Mattress |
|---|---|
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum | 0.08 (0.06 to 0.10) |
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
| µm | Standard Mattress |
|---|---|
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel | 0.43 (0.32 to 0.55) |
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
| µm | Standard Mattress |
|---|---|
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel | 0.45 (0.38 to 0.51) |
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
| µm | Standard Mattress |
|---|---|
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area) | 0.08 (0.06 to 0.09) |
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
| µm | Standard Mattress |
|---|---|
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area) | 0.08 (0.07 to 0.09) |
TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany)
| g/m2/h | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline | 10.4 (9.3 to 11.8) | 9.8 (8.6 to 10.8) | 9.8 (8.7 to 12.3) |
TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
| g/m2/h | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading | 8.3 (7.1 to 8.9) | 8.0 (7.2 to 8.7) | 8.1 (7.7 to 10.8) |
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
| °C | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline | 30.8 (29.9 to 31.2) | 30.7 (30.1 to 31.1) | 30.9 (30.4 to 31.2) |
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
| °C | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading | 29.9 (29.1 to 31.1) | 30.2 (29.7 to 30.9) | 30.6 (30.0 to 31.3) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline | 317.7 (275.7 to 446.3) | 342 (266.9 to 417.9) | 390.2 (307.8 to 445.2) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading | 344.2 (305.0 to 425.9) | 350.2 (286.5 to 411.9) | 325.9 (280.5 to 482.5) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline | 48.1 (38.9 to 53.6) | 50.0 (41.4 to 60.9) | 47.0 (38.7 to 57.7) |
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.
| arbitrary units | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading | 46.7 (34.1 to 50.5) | 43.7 (35.5 to 53.9) | 44.3 (31.7 to 62.8) |
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 %).
| percentage of tissue water content | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline | 50.0 (49.0 to 52.5) | 52.0 (44.5 to 55.5) | 51.5 (37.5 to 57.5) |
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 %).
| percentage of tissue water content | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading | 45.5 (41.0 to 55.0) | 51.5 (43.0 to 55.5) | 51.5 (47.5 to 56.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline | 36.5 (32.0 to 40.0) | 37.8 (31.5 to 42.9) | 35.0 (31.0 to 40.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading | 29.0 (26.0 to 32.5) | 28.5 (26.0 to 34.0) | 28.0 (23.5 to 32.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline | 8.0 (7.0 to 9.0) | 7.3 (7.0 to 8.5) | 8.5 (7.0 to 9.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading | 7.0 (6.0 to 9.0) | 7.0 (6.0 to 7.5) | 7.0 (6.0 to 8.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline | 48.5 (41.5 to 51.5) | 49.0 (41.5 to 56.6) | 44.5 (38.5 to 52.0) |
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.
| µm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading | 38.5 (34.0 to 42.0) | 38.5 (34.5 to 42.5) | 36.0 (30.5 to 41.5) |
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).
| mm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline | 0.34 (0.25 to 0.39) | 0.32 (0.28 to 0.37) | 0.36 (0.28 to 0.42) |
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).
| mm | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading | 0.32 (0.27 to 0.39) | 0.32 (0.24 to 0.34) | 0.37 (0.27 to 0.40) |
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.
| percentage of net elasticity | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline | 0.59 (0.47 to 0.98) | 0.32 (0.28 to 0.37) | 0.70 (0.57 to 0.80) |
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.
| percentage of net elasticity | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading | 0.71 (0.49 to 1.00) | 0.32 (0.24 to 0.34) | 0.68 (0.49 to 0.95) |
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.
| proportion of the elastic recovery | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline | 0.42 (0.32 to 0.64) | 0.43 (0.31 to 0.57) | 0.47 (0.42 to 0.59) |
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.
| proportion of the elastic recovery | Alternating Low Pressure Mattress | Reactive Support Surface | Standard Mattress |
|---|---|---|---|
| Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading | 0.47 (0.33 to 0.66) | 0.48 (0.41 to 0.58) | 0.43 (0.38 to 0.61) |
Collected over Adverse event immediately or after loading of 2 hours on every of the three types of mattresses during each visit (three visits per subject, observation lasted up to 1 hour after each intervention) between September 2016 and March 2017 should be documented.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alternating Low Pressure Mattress | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Reactive Support Surface | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Standard Mattress | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
Cross-over trial. In total 15 participants, each of them lied on every of the three types of mattress.
| Age, Continuous(years) | AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam |
|---|---|
| Median | 66 (63 to 69) |
| Sex: Female, Male(Participants) | AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam |
|---|---|
| Female | 15 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam |
|---|
| Region of Enrollment(participants) | AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam |
|---|---|
| Germany | 15 |
| Body Mass Index (BMI)(kg/m2) | AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam |
|---|---|
| Median | 24.5 (23.7 to 26.0) |
| Body temperature(°C) | AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam |
|---|---|
| Median | 36.3 (36.3 to 36.6) |
| Heart rate(beats per minute) | AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam |
|---|---|
| Median | 78 (66 to 80) |
| Systolic blood pressure(mmHg) | AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam |
|---|---|
| Median | 125 (115 to 140) |
2 further baseline measures are reported on the registry.
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This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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Charite University, Berlin, Germany