Back to resultsEffects of Different Support Surfaces on the Properties Skin After Loading
Primary Purpose
Pressure Ulcers
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Alternating low pressure mattress with air loss function
Gel mattress
Basic foam
Sponsored by
About this trial
This is an interventional supportive care trial for Pressure Ulcers
Eligibility Criteria
Inclusion Criteria:
- Healthy, female volunteers
- 60 to 80 years
- Body Mass Index between 18.5 and 29.9 kg/m2
- Non-Smoker of at least one year
- Absence of skin diseases or scars in the skin areas of interest
- Ability to move independently and to maintain supine and prone positions
- Able to give written informed consent
- No use of cosmetic products or topical applied drugs on the study areas at least 12 hours before measurement
- Skin phototype I to III according to Fitzpatrick classification
- Willing and able to fulfil the study requirements
Exclusion Criteria:
- Disability to maintain in supine or prone position
- Acute diseases
- Acute or chronic diseases with increased or decreased body temperature (≤ 35°C or ≥ 38,5°C, measured in the ear)
- History or establishment of Diabetes or pre-diabetes, cardiac or renal insufficiency, atopic dermatitis, psoriasis, chronic obstructive pulmonary disease (COPD)
- Acute or chronic wounds in the skin areas of interest
- Any skin affection which may interfere with the study assessment, e.g. tattoo, psoriasis or scar on the investigational sites
- Participation in another clinical study 4 weeks before inclusion visit
- Current participation in any other clinical study
Sites / Locations
- Charité-Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Low Pressure mattress
Reactive support surface
Standard mattress
Arm Description
Alternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA)
Gel mattress (IsoGel, stryker, USA)
basic foam
Outcomes
Primary Outcome Measures
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Secondary Outcome Measures
Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Erythema Index in Arbitrary Units at the Sacrum, at Baseline
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Erythema Index in Arbitrary Units at the Heels, at Baseline
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Skin Extensibility (Uf) in mm at the Sacrum, at Baseline
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted with a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm(Uf, mm).
Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the Skin in mm (Uf, mm).
Skin Extensibility (Uf) in mm at the Heel, at Baseline
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Elastic Recovery (Ur/Uf) at the Heel, at Baseline
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Skin Elastic Function (Ur/Ue) at the Heel, at Baseline
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline
TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany)
Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading
TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Full Information
NCT ID
NCT02930590
First Posted
September 26, 2016
Last Updated
May 25, 2022
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT02930590
Brief Title
Effects of Different Support Surfaces on the Properties Skin After Loading
Official Title
Comparing the Effects of Three Different Support Surfaces on the Properties of Heel and Sacral Skin After Loading
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide. There is common agreement, that effective pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. Besides risk assessment and repositioning the use of special pressure ulcer preventive support surfaces are the key interventions in pressure ulcer prevention. Pressure ulcer preventive support surface modify the degree of skin and tissue deformation and/or skin temperature and moisture. Therefore, an association between the type and working mechanism of a pressure ulcer support surface and skin function after loading is highly likely. Furthermore, such a relationship may be used to characterize and/or to quantify the performance pressure ulcer support surfaces in terms of skin protection. The overall aim of this explorative study is to measure skin responses of the two most common pressure ulcer predilection sites (heel, sacral skin) after two hours loading on three different support surfaces and the sternal skin (control area).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcers
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Pressure mattress
Arm Type
Experimental
Arm Description
Alternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA)
Arm Title
Reactive support surface
Arm Type
Experimental
Arm Description
Gel mattress (IsoGel, stryker, USA)
Arm Title
Standard mattress
Arm Type
Active Comparator
Arm Description
basic foam
Intervention Type
Other
Intervention Name(s)
Alternating low pressure mattress with air loss function
Intervention Description
IsoAir, Stryker, USA
Intervention Type
Other
Intervention Name(s)
Gel mattress
Intervention Description
IsoGel, Stryker, USA
Intervention Type
Other
Intervention Name(s)
Basic foam
Intervention Description
Standard hospital mattress
Primary Outcome Measure Information:
Title
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline
Description
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Time Frame
at baseline
Title
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading
Description
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Time Frame
after two hours loading
Title
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading
Description
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Time Frame
20 min after off-loading
Title
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline
Description
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Time Frame
at baseline
Title
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading
Description
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Time Frame
after two hours loading
Title
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading
Description
TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Time Frame
20 min after off-loading
Secondary Outcome Measure Information:
Title
Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline
Description
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Time Frame
at baseline
Title
Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours
Description
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Time Frame
after two hours
Title
Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading
Description
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Time Frame
20 minutes after off-loading
Title
Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline
Description
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Time Frame
at baseline
Title
Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading
Description
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Time Frame
after two hours loading
Title
Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading
Description
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Time Frame
20 minutes after off-loading
Title
Erythema Index in Arbitrary Units at the Sacrum, at Baseline
Description
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Time Frame
at baseline
Title
Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading
Description
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Time Frame
after two hours loading
Title
Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading
Description
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Time Frame
20 min after off-loading
Title
Erythema Index in Arbitrary Units at the Heels, at Baseline
Description
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Time Frame
at baseline
Title
Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading
Description
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Time Frame
after two hours loading
Title
Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading
Description
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Time Frame
20 min after off-loading
Title
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline
Description
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Time Frame
at baseline
Title
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading
Description
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Time Frame
after two hours loading
Title
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading
Description
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer.
Time Frame
20 min after off-loading
Title
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline
Description
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer.
Time Frame
Baseline
Title
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading
Description
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Time Frame
after two hours loading
Title
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading
Description
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Time Frame
20 min after off-loading
Title
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Time Frame
Baseline
Title
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Time Frame
after two hours loading
Title
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Time Frame
20 min after off-loading
Title
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Time Frame
Baseline
Title
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Time Frame
after two hours loading
Title
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Time Frame
20 min after off-loading
Title
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Time Frame
Baseline
Title
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Time Frame
after two hours loading
Title
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Time Frame
20 minutes after off-loading
Title
Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Time Frame
Baseline
Title
Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Time Frame
after two hours loading
Title
Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Time Frame
20 min after off-loading
Title
Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Time Frame
Baseline
Title
Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Time Frame
after two hours loading
Title
Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Time Frame
20 min after off-loading
Title
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Time Frame
after two hours loading
Title
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Time Frame
Baseline
Title
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Time Frame
20 minutes after off-loading
Title
Skin Extensibility (Uf) in mm at the Sacrum, at Baseline
Description
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted with a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Time Frame
Baseline
Title
Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading
Description
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm(Uf, mm).
Time Frame
after two hours loading
Title
Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading
Description
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the Skin in mm (Uf, mm).
Time Frame
20 minutes after off-loading
Title
Skin Extensibility (Uf) in mm at the Heel, at Baseline
Description
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Time Frame
Baseline
Title
Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading
Description
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Time Frame
after two hours loading
Title
Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading
Description
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Time Frame
20 minutes after off-loading
Title
Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline
Description
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
Baseline
Title
Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading
Description
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
after two hours loading
Title
Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading
Description
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
20 minutes after off-loading
Title
Elastic Recovery (Ur/Uf) at the Heel, at Baseline
Description
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
Baseline
Title
Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading
Description
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
after two hours loading
Title
Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading
Description
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
20 minutes after off-loading
Title
Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline
Description
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
Baseline
Title
Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading
Description
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
after two hours loading
Title
Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading
Description
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
20 minutes after off-loading
Title
Skin Elastic Function (Ur/Ue) at the Heel, at Baseline
Description
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
Baseline
Title
Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading
Description
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
after two hours loading
Title
Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading
Description
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
20 minutes after off-loading
Title
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline
Description
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Time Frame
Baseline
Title
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading
Description
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Time Frame
after two hours loading
Title
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading
Description
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Time Frame
20 minutes after off-loading
Title
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline
Description
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Time Frame
Baseline
Title
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading
Description
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Time Frame
after two hours loading
Title
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading
Description
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Time Frame
20 minutes after off-loading
Title
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum
Description
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Time Frame
Baseline
Title
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum
Description
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Time Frame
after two hours loading
Title
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel
Description
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Time Frame
baseline
Title
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel
Description
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Time Frame
after two hours loading
Title
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)
Description
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Time Frame
baseline
Title
Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)
Description
Skin thickness was measured in μm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany).
Time Frame
after two hours loading
Title
Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline
Description
TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany)
Time Frame
at baseline
Title
Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading
Description
TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany).
Time Frame
after two hours loading
Title
Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline
Description
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Time Frame
Baseline
Title
Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading
Description
Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.
Time Frame
after two hours loading
Title
Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline
Description
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Time Frame
Baseline
Title
Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading
Description
Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (λ = 660 nm) and green (λ = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness.
Time Frame
after two hours loading
Title
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline
Description
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Time Frame
Baseline
Title
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading
Description
Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer.
Time Frame
after two hours loading
Title
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline
Description
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Time Frame
Baseline
Title
Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading
Description
Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %).
Time Frame
after two hours loading
Title
Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Time Frame
Baseline
Title
Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group.
Time Frame
after two hours loading
Title
Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Time Frame
Baseline
Title
Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group.
Time Frame
after two hours loading
Title
Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Time Frame
Baseline
Title
Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading
Description
Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values.
Time Frame
after two hours loading
Title
Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline
Description
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Time Frame
Baseline
Title
Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading
Description
Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm).
Time Frame
after two hours loading
Title
Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline
Description
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
Baseline
Title
Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading
Description
The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
after two hours loading
Title
Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline
Description
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
Baseline
Title
Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading
Description
The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter.
Time Frame
after two hours loading
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, female volunteers
60 to 80 years
Body Mass Index between 18.5 and 29.9 kg/m2
Non-Smoker of at least one year
Absence of skin diseases or scars in the skin areas of interest
Ability to move independently and to maintain supine and prone positions
Able to give written informed consent
No use of cosmetic products or topical applied drugs on the study areas at least 12 hours before measurement
Skin phototype I to III according to Fitzpatrick classification
Willing and able to fulfil the study requirements
Exclusion Criteria:
Disability to maintain in supine or prone position
Acute diseases
Acute or chronic diseases with increased or decreased body temperature (≤ 35°C or ≥ 38,5°C, measured in the ear)
History or establishment of Diabetes or pre-diabetes, cardiac or renal insufficiency, atopic dermatitis, psoriasis, chronic obstructive pulmonary disease (COPD)
Acute or chronic wounds in the skin areas of interest
Any skin affection which may interfere with the study assessment, e.g. tattoo, psoriasis or scar on the investigational sites
Participation in another clinical study 4 weeks before inclusion visit
Current participation in any other clinical study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Kottner, PD Dr.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Charité-Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
29277963
Citation
Tomova-Simitchieva T, Lichterfeld-Kottner A, Blume-Peytavi U, Kottner J. Comparing the effects of 3 different pressure ulcer prevention support surfaces on the structure and function of heel and sacral skin: An exploratory cross-over trial. Int Wound J. 2018 Jun;15(3):429-437. doi: 10.1111/iwj.12883. Epub 2017 Dec 26.
Results Reference
result
Learn more about this trial
Effects of Different Support Surfaces on the Properties Skin After Loading
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