Trial Outcomes & Findings for Effects of Different Support Surfaces on the Properties Skin After Loading (NCT NCT02930590)
NCT ID: NCT02930590
Last Updated: 2022-06-14
Results Overview
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
COMPLETED
NA
15 participants
at baseline
2022-06-14
Participant Flow
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.
Participant milestones
| Measure |
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)
|
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)
|
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)
|
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)
|
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)
|
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)
|
|---|---|---|---|---|---|---|
|
First Intervention (2 Hours)
STARTED
|
3
|
3
|
3
|
2
|
2
|
2
|
|
First Intervention (2 Hours)
COMPLETED
|
3
|
3
|
3
|
2
|
2
|
2
|
|
First Intervention (2 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Second Intervention (2 Hours)
STARTED
|
3
|
3
|
3
|
2
|
2
|
2
|
|
Second Intervention (2 Hours)
COMPLETED
|
3
|
3
|
3
|
2
|
2
|
2
|
|
Second Intervention (2 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Third Intervention (2 Hours)
STARTED
|
3
|
3
|
3
|
2
|
2
|
2
|
|
Third Intervention (2 Hours)
COMPLETED
|
3
|
3
|
3
|
2
|
2
|
2
|
|
Third Intervention (2 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
AlternatingLow Pressure Mattress,Reactive Mattress,Basic Foam
n=15 Participants
Cross-over trial. In total 15 participants, each of them lied on every of the three types of mattress.
|
|---|---|
|
Age, Continuous
|
66 years
n=15 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
|
Region of Enrollment
Germany
|
15 participants
n=15 Participants
|
|
Body Mass Index (BMI)
|
24.5 kg/m2
n=15 Participants
|
|
Body temperature
|
36.3 °C
n=15 Participants
|
|
Heart rate
|
78 beats per minute
n=15 Participants
|
|
Systolic blood pressure
|
125 mmHg
n=15 Participants
|
|
Diastolic blood pressure
|
75 mmHg
n=15 Participants
|
|
Skin phototype
Skin phototype I
|
3 Participants
n=15 Participants
|
|
Skin phototype
Skin phototype II
|
9 Participants
n=15 Participants
|
|
Skin phototype
Skin phototype III
|
3 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: at baselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline
|
7.8 g/m2/h
Interval 6.7 to 8.8
|
7.7 g/m2/h
Interval 6.7 to 8.2
|
7.1 g/m2/h
Interval 6.8 to 8.8
|
PRIMARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading
|
12.4 g/m2/h
Interval 11.5 to 15.2
|
10.4 g/m2/h
Interval 8.5 to 12.2
|
14.5 g/m2/h
Interval 9.3 to 20.5
|
PRIMARY outcome
Timeframe: 20 min after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading
|
8.0 g/m2/h
Interval 7.0 to 8.6
|
7.6 g/m2/h
Interval 6.4 to 8.6
|
8.0 g/m2/h
Interval 6.8 to 9.0
|
PRIMARY outcome
Timeframe: at baselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline
|
8.1 g/m2/h
Interval 7.6 to 10.9
|
9.4 g/m2/h
Interval 8.2 to 11.6
|
8.6 g/m2/h
Interval 7.4 to 12.1
|
PRIMARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading
|
19.5 g/m2/h
Interval 16.6 to 25.3
|
19.2 g/m2/h
Interval 16.3 to 23.3
|
28.4 g/m2/h
Interval 15.9 to 32.3
|
PRIMARY outcome
Timeframe: 20 min after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading
|
9.6 g/m2/h
Interval 9.0 to 11.2
|
10.4 g/m2/h
Interval 8.9 to 13.3
|
11.1 g/m2/h
Interval 9.9 to 14.8
|
SECONDARY outcome
Timeframe: at baselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline
|
28.8 °C
Interval 28.2 to 29.2
|
28.9 °C
Interval 28.3 to 29.2
|
29.1 °C
Interval 28.1 to 29.8
|
SECONDARY outcome
Timeframe: after two hoursPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours
|
31.4 °C
Interval 31.3 to 32.0
|
30.7 °C
Interval 30.5 to 31.3
|
32.0 °C
Interval 31.3 to 32.2
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading
|
30.3 °C
Interval 29.8 to 30.6
|
29.4 °C
Interval 29.2 to 30.1
|
30.3 °C
Interval 29.8 to 31.1
|
SECONDARY outcome
Timeframe: at baselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline
|
24.4 °C
Interval 24.1 to 25.2
|
25.2 °C
Interval 24.3 to 25.4
|
24.3 °C
Interval 23.3 to 25.4
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading
|
26.5 °C
Interval 25.4 to 26.9
|
25.5 °C
Interval 24.7 to 26.2
|
26.6 °C
Interval 25.5 to 27.3
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading
|
25.4 °C
Interval 24.9 to 26.0
|
25.2 °C
Interval 23.8 to 25.4
|
25.9 °C
Interval 24.9 to 26.6
|
SECONDARY outcome
Timeframe: at baselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Erythema Index in Arbitrary Units at the Sacrum, at Baseline
|
187.5 arbitrary units
Interval 164.4 to 224.3
|
176.5 arbitrary units
Interval 142.7 to 211.1
|
167.2 arbitrary units
Interval 150.5 to 193.7
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading
|
220.2 arbitrary units
Interval 185.0 to 251.4
|
206.0 arbitrary units
Interval 153.2 to 238.5
|
235.9 arbitrary units
Interval 191.3 to 275.2
|
SECONDARY outcome
Timeframe: 20 min after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading
|
201.3 arbitrary units
Interval 177.8 to 233.5
|
194.0 arbitrary units
Interval 147.0 to 218.5
|
221.0 arbitrary units
Interval 191.4 to 239.9
|
SECONDARY outcome
Timeframe: at baselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Erythema Index in Arbitrary Units at the Heels, at Baseline
|
194.5 arbitrary units
Interval 132.2 to 225.4
|
177.9 arbitrary units
Interval 143.2 to 250.9
|
186.2 arbitrary units
Interval 116.7 to 234.7
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading
|
247.1 arbitrary units
Interval 146.9 to 279.2
|
225.7 arbitrary units
Interval 160.0 to 272.5
|
225.2 arbitrary units
Interval 183.5 to 290.5
|
SECONDARY outcome
Timeframe: 20 min after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading
|
231.9 arbitrary units
Interval 145.9 to 246.0
|
188.5 arbitrary units
Interval 142.8 to 236.0
|
226.7 arbitrary units
Interval 143.7 to 246.9
|
SECONDARY outcome
Timeframe: at baselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline
|
27.2 arbitrary units
Interval 19.7 to 34.7
|
23.8 arbitrary units
Interval 19.5 to 35.8
|
27.5 arbitrary units
Interval 25.1 to 36.2
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading
|
34.6 arbitrary units
Interval 25.3 to 40.4
|
29.8 arbitrary units
Interval 22.0 to 40.0
|
31.6 arbitrary units
Interval 26.1 to 42.5
|
SECONDARY outcome
Timeframe: 20 min after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading
|
29.3 arbitrary units
Interval 25.6 to 35.9
|
27.4 arbitrary units
Interval 22.7 to 36.4
|
30.1 arbitrary units
Interval 23.9 to 39.6
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline
|
13.3 arbitrary units
Interval 8.3 to 19.2
|
13.6 arbitrary units
Interval 9.3 to 21.1
|
12.9 arbitrary units
Interval 8.7 to 17.8
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading
|
18.0 arbitrary units
Interval 13.9 to 23.4
|
17.9 arbitrary units
Interval 12.5 to 23.4
|
20.2 arbitrary units
Interval 14.5 to 24.6
|
SECONDARY outcome
Timeframe: 20 min after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading
|
14.4 arbitrary units
Interval 10.7 to 22.1
|
12.9 arbitrary units
Interval 8.3 to 19.2
|
15.3 arbitrary units
Interval 10.8 to 17.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline
|
39.5 µm
Interval 33.5 to 41.0
|
35.5 µm
Interval 33.3 to 44.6
|
34.0 µm
Interval 32.0 to 41.5
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading
|
39.0 µm
Interval 36.0 to 43.5
|
40.0 µm
Interval 37.0 to 43.5
|
39.5 µm
Interval 34.0 to 44.0
|
SECONDARY outcome
Timeframe: 20 min after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading
|
43.0 µm
Interval 38.5 to 50.5
|
40.5 µm
Interval 36.0 to 49.0
|
42.5 µm
Interval 37.0 to 46.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline
|
9.0 µm
Interval 8.0 to 10.0
|
8.3 µm
Interval 6.9 to 10.1
|
8.0 µm
Interval 7.5 to 10.0
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading
|
9.0 µm
Interval 8.0 to 11.5
|
9.0 µm
Interval 8.5 to 10.0
|
8.5 µm
Interval 7.5 to 10.0
|
SECONDARY outcome
Timeframe: 20 min after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading
|
10.0 µm
Interval 8.5 to 12.0
|
9.5 µm
Interval 8.5 to 10.0
|
9.0 µm
Interval 8.0 to 11.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline
|
51.0 µm
Interval 42.5 to 56.0
|
47.5 µm
Interval 42.8 to 57.0
|
46.5 µm
Interval 38.5 to 53.5
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading
|
51.0 µm
Interval 45.5 to 59.0
|
50.0 µm
Interval 46.0 to 57.5
|
52.0 µm
Interval 43.5 to 58.5
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading
|
57.0 µm
Interval 49.5 to 63.5
|
52.5 µm
Interval 45.5 to 65.0
|
52.0 µm
Interval 47.5 to 61.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline
|
48.5 µm
Interval 32.0 to 68.0
|
48.3 µm
Interval 36.1 to 59.4
|
51.5 µm
Interval 34.5 to 72.0
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading
|
50.5 µm
Interval 43.5 to 63.5
|
51.5 µm
Interval 45.0 to 72.0
|
51.0 µm
Interval 39.5 to 70.5
|
SECONDARY outcome
Timeframe: 20 min after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading
|
52.5 µm
Interval 46.0 to 73.0
|
59.5 µm
Interval 53.0 to 88.0
|
55.0 µm
Interval 40.0 to 58.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline
|
9.0 µm
Interval 7.5 to 13.5
|
9.8 µm
Interval 7.9 to 12.0
|
9.5 µm
Interval 7.0 to 15.5
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading
|
10.0 µm
Interval 7.5 to 12.0
|
10.0 µm
Interval 9.0 to 12.0
|
8.5 µm
Interval 7.5 to 13.0
|
SECONDARY outcome
Timeframe: 20 min after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading
|
10.5 µm
Interval 8.5 to 14.0
|
11.5 µm
Interval 9.5 to 17.0
|
9.0 µm
Interval 8.0 to 11.5
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading
|
67.5 µm
Interval 59.0 to 83.0
|
73.5 µm
Interval 57.0 to 100.5
|
67.5 µm
Interval 52.0 to 93.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline
|
63.5 µm
Interval 44.0 to 93.0
|
63.8 µm
Interval 46.6 to 79.5
|
70.0 µm
Interval 44.5 to 91.0
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading
|
71.5 µm
Interval 61.5 to 94.5
|
81.5 µm
Interval 69.0 to 110.5
|
70.0 µm
Interval 54.0 to 81.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Extensibility (Uf) in mm at the Sacrum, at Baseline
|
0.32 mm
Interval 0.31 to 0.35
|
0.29 mm
Interval 0.26 to 0.33
|
0.32 mm
Interval 0.28 to 0.34
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading
|
0.34 mm
Interval 0.32 to 0.4
|
0.32 mm
Interval 0.28 to 0.37
|
0.35 mm
Interval 0.32 to 0.37
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading
|
0.33 mm
Interval 0.3 to 0.38
|
0.31 mm
Interval 0.27 to 0.35
|
0.32 mm
Interval 0.3 to 0.37
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Extensibility (Uf) in mm at the Heel, at Baseline
|
0.08 mm
Interval 0.07 to 0.12
|
0.08 mm
Interval 0.06 to 0.1
|
0.09 mm
Interval 0.08 to 0.1
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading
|
0.10 mm
Interval 0.08 to 0.12
|
0.10 mm
Interval 0.1 to 0.12
|
0.10 mm
Interval 0.08 to 0.12
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading
|
0.08 mm
Interval 0.07 to 0.12
|
0.09 mm
Interval 0.06 to 0.11
|
0.10 mm
Interval 0.08 to 0.12
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline
|
0.55 proportion of the elastic recovery
Interval 0.42 to 0.64
|
0.52 proportion of the elastic recovery
Interval 0.46 to 0.64
|
0.57 proportion of the elastic recovery
Interval 0.43 to 0.66
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading
|
0.55 proportion of the elastic recovery
Interval 0.42 to 0.65
|
0.50 proportion of the elastic recovery
Interval 0.42 to 0.66
|
0.44 proportion of the elastic recovery
Interval 0.42 to 0.64
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading
|
0.52 proportion of the elastic recovery
Interval 0.41 to 0.68
|
0.45 proportion of the elastic recovery
Interval 0.37 to 0.66
|
0.51 proportion of the elastic recovery
Interval 0.44 to 0.64
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Elastic Recovery (Ur/Uf) at the Heel, at Baseline
|
0.36 proportion of the elastic recovery
Interval 0.32 to 0.42
|
0.35 proportion of the elastic recovery
Interval 0.33 to 0.39
|
0.35 proportion of the elastic recovery
Interval 0.33 to 0.43
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading
|
0.35 proportion of the elastic recovery
Interval 0.3 to 0.37
|
0.36 proportion of the elastic recovery
Interval 0.32 to 0.4
|
0.38 proportion of the elastic recovery
Interval 0.32 to 0.42
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading
|
0.34 proportion of the elastic recovery
Interval 0.32 to 0.38
|
0.36 proportion of the elastic recovery
Interval 0.33 to 0.38
|
0.35 proportion of the elastic recovery
Interval 0.32 to 0.37
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline
|
0.79 percentage of net elasticity
Interval 0.54 to 0.9
|
0.78 percentage of net elasticity
Interval 0.65 to 0.96
|
0.80 percentage of net elasticity
Interval 0.67 to 0.97
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading
|
0.81 percentage of net elasticity
Interval 0.65 to 0.87
|
0.70 percentage of net elasticity
Interval 0.63 to 0.93
|
0.65 percentage of net elasticity
Interval 0.56 to 0.9
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading
|
0.75 percentage of net elasticity
Interval 0.56 to 0.92
|
0.66 percentage of net elasticity
Interval 0.57 to 0.97
|
0.72 percentage of net elasticity
Interval 0.59 to 0.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Elastic Function (Ur/Ue) at the Heel, at Baseline
|
0.67 percentage of net elasticity
Interval 0.64 to 0.77
|
0.68 percentage of net elasticity
Interval 0.63 to 0.98
|
0.68 percentage of net elasticity
Interval 0.62 to 0.85
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading
|
0.66 percentage of net elasticity
Interval 0.58 to 0.79
|
0.70 percentage of net elasticity
Interval 0.62 to 0.83
|
0.70 percentage of net elasticity
Interval 0.62 to 0.81
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading
|
0.67 percentage of net elasticity
Interval 0.61 to 0.79
|
0.67 percentage of net elasticity
Interval 0.64 to 0.74
|
0.67 percentage of net elasticity
Interval 0.61 to 0.75
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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 %).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline
|
41.0 percentage of tissue water content
Interval 39.6 to 43.6
|
40.0 percentage of tissue water content
Interval 36.5 to 42.0
|
41.0 percentage of tissue water content
Interval 39.0 to 47.0
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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 %).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading
|
44.5 percentage of tissue water content
Interval 42.5 to 48.5
|
41.5 percentage of tissue water content
Interval 40.5 to 47.5
|
43.5 percentage of tissue water content
Interval 41.0 to 49.5
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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 %).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading
|
44.5 percentage of tissue water content
Interval 43.0 to 46.0
|
42.5 percentage of tissue water content
Interval 39.5 to 46.5
|
44.0 percentage of tissue water content
Interval 41.0 to 48.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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 %).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline
|
25.5 percentage of tissue water content
Interval 21.5 to 29.0
|
25.5 percentage of tissue water content
Interval 21.5 to 30.0
|
24.0 percentage of tissue water content
Interval 21.5 to 27.5
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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 %).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading
|
28.0 percentage of tissue water content
Interval 25.0 to 32.0
|
25.5 percentage of tissue water content
Interval 25.0 to 27.5
|
28.0 percentage of tissue water content
Interval 27.0 to 31.5
|
SECONDARY outcome
Timeframe: 20 minutes after off-loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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 %).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading
|
25.5 percentage of tissue water content
Interval 22.5 to 30.0
|
25.5 percentage of tissue water content
Interval 23.5 to 28.0
|
25.5 percentage of tissue water content
Interval 23.5 to 28.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum
|
0.09 µm
Interval 0.08 to 0.12
|
—
|
—
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum
|
0.08 µm
Interval 0.06 to 0.1
|
—
|
—
|
SECONDARY outcome
Timeframe: baselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel
|
0.43 µm
Interval 0.32 to 0.55
|
—
|
—
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel
|
0.45 µm
Interval 0.38 to 0.51
|
—
|
—
|
SECONDARY outcome
Timeframe: baselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)
|
0.08 µm
Interval 0.06 to 0.09
|
—
|
—
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)
|
0.08 µm
Interval 0.07 to 0.09
|
—
|
—
|
SECONDARY outcome
Timeframe: at baselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany)
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline
|
10.4 g/m2/h
Interval 9.3 to 11.8
|
9.8 g/m2/h
Interval 8.6 to 10.8
|
9.8 g/m2/h
Interval 8.7 to 12.3
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading
|
8.3 g/m2/h
Interval 7.1 to 8.9
|
8.0 g/m2/h
Interval 7.2 to 8.7
|
8.1 g/m2/h
Interval 7.7 to 10.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline
|
30.8 °C
Interval 29.9 to 31.2
|
30.7 °C
Interval 30.1 to 31.1
|
30.9 °C
Interval 30.4 to 31.2
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
Skin thermometer based on the infrared technique (Courage \& Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading
|
29.9 °C
Interval 29.1 to 31.1
|
30.2 °C
Interval 29.7 to 30.9
|
30.6 °C
Interval 30.0 to 31.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline
|
317.7 arbitrary units
Interval 275.7 to 446.3
|
342 arbitrary units
Interval 266.9 to 417.9
|
390.2 arbitrary units
Interval 307.8 to 445.2
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading
|
344.2 arbitrary units
Interval 305.0 to 425.9
|
350.2 arbitrary units
Interval 286.5 to 411.9
|
325.9 arbitrary units
Interval 280.5 to 482.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline
|
48.1 arbitrary units
Interval 38.9 to 53.6
|
50.0 arbitrary units
Interval 41.4 to 60.9
|
47.0 arbitrary units
Interval 38.7 to 57.7
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading
|
46.7 arbitrary units
Interval 34.1 to 50.5
|
43.7 arbitrary units
Interval 35.5 to 53.9
|
44.3 arbitrary units
Interval 31.7 to 62.8
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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 %).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline
|
50.0 percentage of tissue water content
Interval 49.0 to 52.5
|
52.0 percentage of tissue water content
Interval 44.5 to 55.5
|
51.5 percentage of tissue water content
Interval 37.5 to 57.5
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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 %).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading
|
45.5 percentage of tissue water content
Interval 41.0 to 55.0
|
51.5 percentage of tissue water content
Interval 43.0 to 55.5
|
51.5 percentage of tissue water content
Interval 47.5 to 56.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline
|
36.5 µm
Interval 32.0 to 40.0
|
37.8 µm
Interval 31.5 to 42.9
|
35.0 µm
Interval 31.0 to 40.0
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading
|
29.0 µm
Interval 26.0 to 32.5
|
28.5 µm
Interval 26.0 to 34.0
|
28.0 µm
Interval 23.5 to 32.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline
|
8.0 µm
Interval 7.0 to 9.0
|
7.3 µm
Interval 7.0 to 8.5
|
8.5 µm
Interval 7.0 to 9.0
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading
|
7.0 µm
Interval 6.0 to 9.0
|
7.0 µm
Interval 6.0 to 7.5
|
7.0 µm
Interval 6.0 to 8.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline
|
48.5 µm
Interval 41.5 to 51.5
|
49.0 µm
Interval 41.5 to 56.6
|
44.5 µm
Interval 38.5 to 52.0
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading
|
38.5 µm
Interval 34.0 to 42.0
|
38.5 µm
Interval 34.5 to 42.5
|
36.0 µm
Interval 30.5 to 41.5
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline
|
0.34 mm
Interval 0.25 to 0.39
|
0.32 mm
Interval 0.28 to 0.37
|
0.36 mm
Interval 0.28 to 0.42
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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).
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading
|
0.32 mm
Interval 0.27 to 0.39
|
0.32 mm
Interval 0.24 to 0.34
|
0.37 mm
Interval 0.27 to 0.4
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline
|
0.59 percentage of net elasticity
Interval 0.47 to 0.98
|
0.32 percentage of net elasticity
Interval 0.28 to 0.37
|
0.70 percentage of net elasticity
Interval 0.57 to 0.8
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lied on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading
|
0.71 percentage of net elasticity
Interval 0.49 to 1.0
|
0.32 percentage of net elasticity
Interval 0.24 to 0.34
|
0.68 percentage of net elasticity
Interval 0.49 to 0.95
|
SECONDARY outcome
Timeframe: BaselinePopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lay on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline
|
0.42 proportion of the elastic recovery
Interval 0.32 to 0.64
|
0.43 proportion of the elastic recovery
Interval 0.31 to 0.57
|
0.47 proportion of the elastic recovery
Interval 0.42 to 0.59
|
SECONDARY outcome
Timeframe: after two hours loadingPopulation: Cross-over trial with 15 female participants between 60 and 80 years, each of them lay on every of the three types of mattress.
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.
Outcome measures
| Measure |
Alternating Low Pressure Mattress
n=15 Participants
Alternating Low Pressure mattress with low air loss function (IsoAir, Stryker, USA)
Alternating low pressure mattress with air loss function: IsoAir, Stryker, USA
|
Reactive Support Surface
n=15 Participants
Gel mattress (IsoGel, Stryker, USA)
Gel mattress: IsoGel, Stryker, USA
|
Standard Mattress
n=15 Participants
Basic foam (Stryker, USA)
Basic foam: Standard mattress, Stryker, USA
|
|---|---|---|---|
|
Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading
|
0.47 proportion of the elastic recovery
Interval 0.33 to 0.66
|
0.48 proportion of the elastic recovery
Interval 0.41 to 0.58
|
0.43 proportion of the elastic recovery
Interval 0.38 to 0.61
|
Adverse Events
Alternating Low Pressure Mattress
Reactive Support Surface
Standard Mattress
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jan Kottner
Clinical Research Center for Hair and Skin Science, Department of Dermatology and Allergology Charité - Universitätsmedizin Berlin
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place