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Pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide. There is common agreement, that effective pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. Besides risk assessment and repositioning the use of special pressure ulcer preventive support surfaces are the key interventions in pressure ulcer prevention. Pressure ulcer preventive support surface modify the degree of skin and tissue deformation and/or skin temperature and moisture. Therefore, an association between the type and working mechanism of a pressure ulcer support surface and skin function after loading is highly likely. Furthermore, such a relationship may be used to characterize and/or to quantify the performance pressure ulcer support surfaces in terms of skin protection. The overall aim of this explorative study is to measure skin responses of the two most common pressure ulcer predilection sites (heel, sacral skin) after two hours loading on three different support surfaces and the sternal skin (control area).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Pressure mattress | Experimental | Alternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA) |
|
| Reactive support surface | Experimental | Gel mattress (IsoGel, stryker, USA) |
|
| Standard mattress | Active Comparator | basic foam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alternating low pressure mattress with air loss function | Other | IsoAir, Stryker, USA |
|
| Measure | Description | Time Frame |
|---|---|---|
| Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | at baseline |
| Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | after two hours loading |
| Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | 20 min after off-loading |
| Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | at baseline |
| Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | after two hours loading |
| Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | 20 min after off-loading |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | at baseline |
| Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Kottner, PD Dr. | Charite University, Berlin, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité-Universitätsmedizin Berlin | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29277963 | Result | Tomova-Simitchieva T, Lichterfeld-Kottner A, Blume-Peytavi U, Kottner J. Comparing the effects of 3 different pressure ulcer prevention support surfaces on the structure and function of heel and sacral skin: An exploratory cross-over trial. Int Wound J. 2018 Jun;15(3):429-437. doi: 10.1111/iwj.12883. Epub 2017 Dec 26. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Pressure, Reactive Support, Than Standard Mattress | Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA) |
| FG001 | Low Pressure, Standard Mattress, Than Reactive Support | Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA) |
| FG002 | Reactive Support, Low Pressure, Than Standard Mattress | Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA) |
| FG003 | Reactive Support, Standard Mattress, Than Low Pressure | Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA) |
| FG004 | Standard Mattress, Low Pressure, Than Reactive Support | Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA) |
| FG005 | Standard Mattress, Reactive Support, Than Low Pressure | Alternating Low Pressure Mattress with Low Air Loss Function (IsoAir, Stryker, USA) Reactive Support Surface: Gel mattress (IsoGel, Stryker, USA) Standard Mattress: Basic foam (Stryker, USA) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (2 Hours) |
| |||||||||||||
| Second Intervention (2 Hours) |
| |||||||||||||
| Third Intervention (2 Hours) |
|
Cross-over trial. In total 15 participants, each of them lied on every of the three types of mattress.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | g/m2/h | at baseline |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Alternating Low Pressure Mattress | Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA) Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jan Kottner | Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergology Charité - Universitätsmedizin Berlin | +49 30 450 518218 | jan.kottner@charite.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 6, 2017 | Sep 14, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Gel mattress | Other | IsoGel, Stryker, USA |
|
| Basic foam | Other | Standard hospital mattress |
|
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. |
| after two hours |
| Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | 20 minutes after off-loading |
| Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | at baseline |
| Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | after two hours loading |
| Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | 20 minutes after off-loading |
| Erythema Index in Arbitrary Units at the Sacrum, at Baseline | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | at baseline |
| Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | after two hours loading |
| Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | 20 min after off-loading |
| Erythema Index in Arbitrary Units at the Heels, at Baseline | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | at baseline |
| Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | after two hours loading |
| Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | 20 min after off-loading |
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | at baseline |
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | after two hours loading |
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer. | 20 min after off-loading |
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer. | Baseline |
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | after two hours loading |
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | 20 min after off-loading |
| Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | Baseline |
| Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | after two hours loading |
| Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | 20 min after off-loading |
| Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | Baseline |
| Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | after two hours loading |
| Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | 20 min after off-loading |
| Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | Baseline |
| Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | after two hours loading |
| Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | 20 minutes after off-loading |
| Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | Baseline |
| Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | after two hours loading |
| Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | 20 min after off-loading |
| Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | Baseline |
| Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | after two hours loading |
| Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | 20 min after off-loading |
| Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | after two hours loading |
| Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | Baseline |
| Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | 20 minutes after off-loading |
| Skin Extensibility (Uf) in mm at the Sacrum, at Baseline | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted with a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | Baseline |
| Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm(Uf, mm). | after two hours loading |
| Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the Skin in mm (Uf, mm). | 20 minutes after off-loading |
| Skin Extensibility (Uf) in mm at the Heel, at Baseline | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | Baseline |
| Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | after two hours loading |
| Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | 20 minutes after off-loading |
| Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline |
| Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading |
| Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | 20 minutes after off-loading |
| Elastic Recovery (Ur/Uf) at the Heel, at Baseline | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline |
| Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading |
| Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | 20 minutes after off-loading |
| Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline |
| Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading |
| Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | 20 minutes after off-loading |
| Skin Elastic Function (Ur/Ue) at the Heel, at Baseline | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline |
| Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading |
| Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | 20 minutes after off-loading |
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | Baseline |
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | after two hours loading |
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | 20 minutes after off-loading |
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | Baseline |
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | after two hours loading |
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | 20 minutes after off-loading |
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | Baseline |
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | after two hours loading |
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | baseline |
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | after two hours loading |
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area) | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | baseline |
| Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area) | Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). | after two hours loading |
| Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline | TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany) | at baseline |
| Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading | TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | after two hours loading |
| Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | Baseline |
| Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading | Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. | after two hours loading |
| Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | Baseline |
| Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading | Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. | after two hours loading |
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | Baseline |
| Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading | Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. | after two hours loading |
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | Baseline |
| Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading | Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). | after two hours loading |
| Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | Baseline |
| Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. | after two hours loading |
| Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | Baseline |
| Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. | after two hours loading |
| Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | Baseline |
| Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading | Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. | after two hours loading |
| Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | Baseline |
| Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading | Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). | after two hours loading |
| Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline |
| Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading | The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading |
| Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | Baseline |
| Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading | The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. | after two hours loading |
| COMPLETED | Cross-over trial.In total 15 participants,each of them lied on every of the three types of mattress. |
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| NOT COMPLETED |
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| COMPLETED | Cross-over trial.In total 15 participants,each of them lied on every of the three types of mattress. |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Median | Inter-Quartile Range | kg/m2 |
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| Body temperature | Median | Inter-Quartile Range | °C |
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| Heart rate | Median | Inter-Quartile Range | beats per minute |
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| Systolic blood pressure | Median | Inter-Quartile Range | mmHg |
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| Diastolic blood pressure | Median | Inter-Quartile Range | mmHg |
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| Skin phototype | Assessment of the participants' skin phototype according Fitzpatrick classification with six categories. Participants with the skin phototype I (celtic type: fair ivory skin, red or blond hair, blue eyes and freckles; tans never, burns always), II (fair "caucasian": white skin, blond hair, blue or green eyes; tans a little, burns easily) and III (dark "caucasian": white skin, brown hair, gray or brown eyes; tans moderately, burns moderately) have been included in this study. | Count of Participants | Participants |
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| OG002 | Standard Mattress | Basic foam (Stryker, USA) Basic foam: Standard mattress, Stryker, USA |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | g/m2/h | after two hours loading |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | g/m2/h | 20 min after off-loading |
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| Primary | Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline | TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | g/m2/h | at baseline |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | g/m2/h | after two hours loading |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | g/m2/h | 20 min after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | °C | at baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | °C | after two hours |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | °C | 20 minutes after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | °C | at baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | °C | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | °C | 20 minutes after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | at baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | 20 min after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | at baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | 20 min after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | at baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | 20 min after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | 20 min after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | 20 min after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | 20 min after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | 20 minutes after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | 20 min after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | 20 min after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | 20 minutes after off-loading |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | mm | Baseline |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | mm | after two hours loading |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | mm | 20 minutes after off-loading |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | mm | Baseline |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | mm | after two hours loading |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | mm | 20 minutes after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | proportion of the elastic recovery | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | proportion of the elastic recovery | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | proportion of the elastic recovery | 20 minutes after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | proportion of the elastic recovery | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | proportion of the elastic recovery | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | proportion of the elastic recovery | 20 minutes after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of net elasticity | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of net elasticity | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of net elasticity | 20 minutes after off-loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of net elasticity | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of net elasticity | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of net elasticity | 20 minutes after off-loading |
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| 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 %). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of tissue water content | Baseline |
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| 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 %). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of tissue water content | after two hours loading |
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| 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 %). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of tissue water content | 20 minutes after off-loading |
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| 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 %). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of tissue water content | Baseline |
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| 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 %). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of tissue water content | after two hours loading |
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| 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 %). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of tissue water content | 20 minutes after off-loading |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | Baseline |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | baseline |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | baseline |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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) | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | g/m2/h | at baseline |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | g/m2/h | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | °C | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | °C | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | arbitrary units | after two hours loading |
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| 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 %). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of tissue water content | Baseline |
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| 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 %). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of tissue water content | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | µm | after two hours loading |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | mm | Baseline |
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| 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). | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | mm | after two hours loading |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of net elasticity | Baseline |
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| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | percentage of net elasticity | after two hours loading |
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|
|
| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lay on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | proportion of the elastic recovery | Baseline |
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|
|
| 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. | Cross-over trial with 15 female participants between 60 and 80 years, each of them lay on every of the three types of mattress. | Posted | Median | Inter-Quartile Range | proportion of the elastic recovery | after two hours loading |
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|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Reactive Support Surface | Gel mattress (IsoGel, Stryker, USA) Gel mattress: IsoGel, Stryker, USA | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Standard Mattress | Basic foam (IsoGel, Stryker, USA) Basic foam: Standard mattress, Stryker, USA | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided