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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

at baseline

Results posted on

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

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

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 baseline

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

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

Outcome measures

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 loading

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

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

Outcome measures

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-loading

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

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

Outcome measures

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 baseline

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

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

Outcome measures

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 loading

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

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

Outcome measures

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-loading

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

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

Outcome measures

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 baseline

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

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

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 hours

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

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

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-loading

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

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

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 baseline

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

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

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 loading

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

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

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-loading

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

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

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 baseline

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

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

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 loading

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

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

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-loading

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

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

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 baseline

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

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

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 loading

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

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

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-loading

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

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

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 baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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 loading

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

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

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: Baseline

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

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

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 loading

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

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

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-loading

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

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

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: Baseline

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

Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).

Outcome measures

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 loading

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

Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).

Outcome measures

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: baseline

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

Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).

Outcome measures

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 loading

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

Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).

Outcome measures

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: baseline

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

Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).

Outcome measures

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 loading

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

Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).

Outcome measures

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 baseline

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

TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany)

Outcome measures

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 loading

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

TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).

Outcome measures

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: Baseline

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

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

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 loading

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

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

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: Baseline

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

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

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 loading

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

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

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: Baseline

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

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

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 loading

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

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

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: Baseline

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

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

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 loading

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

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

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: Baseline

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

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

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 loading

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

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

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: Baseline

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

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

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 loading

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

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

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: Baseline

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

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

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 loading

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

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

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: Baseline

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

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

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 loading

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

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

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: Baseline

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

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

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 loading

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

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

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: Baseline

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

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

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 loading

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

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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Reactive Support Surface

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Mattress

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: +49 30 450 518218

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place