Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02930590
Other study ID # CRC-PU-A-23
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date March 2017

Study information

Verified date May 2022
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date March 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Alternating low pressure mattress with air loss function
IsoAir, Stryker, USA
Gel mattress
IsoGel, Stryker, USA
Basic foam
Standard hospital mattress

Locations

Country Name City State
Germany Charité-Universitätsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. 2 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). at baseline
Primary Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). after two hours loading
Primary Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). 20 min after off-loading
Primary Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). at baseline
Primary Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). after two hours loading
Primary Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading TEWL was measured using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). 20 min after off-loading
Secondary Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. at baseline
Secondary Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. after two hours
Secondary Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. 20 minutes after off-loading
Secondary Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. at baseline
Secondary Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. after two hours loading
Secondary Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. 20 minutes after off-loading
Secondary Erythema Index in Arbitrary Units at the Sacrum, at Baseline Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (? = 660 nm) and green (? = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. at baseline
Secondary Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (? = 660 nm) and green (? = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. after two hours loading
Secondary Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (? = 660 nm) and green (? = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. 20 min after off-loading
Secondary Erythema Index in Arbitrary Units at the Heels, at Baseline Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (? = 660 nm) and green (? = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. at baseline
Secondary Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (? = 660 nm) and green (? = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. after two hours loading
Secondary Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (? = 660 nm) and green (? = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. 20 min after off-loading
Secondary Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. at baseline
Secondary Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. after two hours loading
Secondary Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer. 20 min after off-loading
Secondary Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU).Lower values represent reduced skin hydration in the upper skin layer. Baseline
Secondary Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. after two hours loading
Secondary Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. 20 min after off-loading
Secondary Skin Surface Mean Roughness (Rz) in µm at the Sacrum, at Baseline Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. Baseline
Secondary Skin Surface Mean Roughness (Rz) in µm at the Sacrum, After Two Hours Loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. after two hours loading
Secondary Skin Surface Mean Roughness (Rz) in µm at the Sacrum, 20 Min After Off-loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. 20 min after off-loading
Secondary Skin Surface Mean Roughness (Ra) in µm at the Sacrum, at Baseline Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. Baseline
Secondary Skin Surface Mean Roughness (Ra) in µm at the Sacrum, After Two Hours Loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. after two hours loading
Secondary Skin Surface Mean Roughness (Ra) in µm at the Sacrum, 20 Min Off-loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. 20 min after off-loading
Secondary Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. Baseline
Secondary Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. after two hours loading
Secondary Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. 20 minutes after off-loading
Secondary Skin Surface Mean Roughness (Rz) in µm at the Heel, at Baseline Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. Baseline
Secondary Skin Surface Mean Roughness (Rz) in µm at the Heels, After Two Hours Loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. after two hours loading
Secondary Skin Surface Mean Roughness (Rz) in µm at the Heels, 20min Off-loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. 20 min after off-loading
Secondary Skin Surface Mean Roughness (Ra) in µm at the Heels, at Baseline Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. Baseline
Secondary Skin Surface Mean Roughness (Ra) in µm at the Heels, After Two Hours Loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. after two hours loading
Secondary Skin Surface Mean Roughness (Ra) in µm at the Heels, 20 Min After Off-loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. 20 min after off-loading
Secondary Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. after two hours loading
Secondary Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. Baseline
Secondary Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. 20 minutes after off-loading
Secondary Skin Extensibility (Uf) in mm at the Sacrum, at Baseline Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted with a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). Baseline
Secondary Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm(Uf, mm). after two hours loading
Secondary Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the Skin in mm (Uf, mm). 20 minutes after off-loading
Secondary Skin Extensibility (Uf) in mm at the Heel, at Baseline Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). Baseline
Secondary Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). after two hours loading
Secondary Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). 20 minutes after off-loading
Secondary Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. Baseline
Secondary Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. after two hours loading
Secondary Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. 20 minutes after off-loading
Secondary Elastic Recovery (Ur/Uf) at the Heel, at Baseline The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. Baseline
Secondary Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. after two hours loading
Secondary Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. 20 minutes after off-loading
Secondary Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. Baseline
Secondary Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. after two hours loading
Secondary Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. 20 minutes after off-loading
Secondary Skin Elastic Function (Ur/Ue) at the Heel, at Baseline The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. Baseline
Secondary Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. after two hours loading
Secondary Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. 20 minutes after off-loading
Secondary Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). Baseline
Secondary Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). after two hours loading
Secondary Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). 20 minutes after off-loading
Secondary Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). Baseline
Secondary Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). after two hours loading
Secondary Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). 20 minutes after off-loading
Secondary Epidermal Thickness in µm (Metric) by Image Processing and Measurement at the Sacrum Skin thickness was measured in µm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). Baseline
Secondary Epidermal Thickness in µm (Metric) by Image Processing and Measurement at the Sacrum Skin thickness was measured in µm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). after two hours loading
Secondary Epidermal Thickness in µm (Metric) by Image Processing and Measurement at the Heel Skin thickness was measured in µm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). baseline
Secondary Epidermal Thickness in µm (Metric) by Image Processing and Measurement at the Heel Skin thickness was measured in µm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). after two hours loading
Secondary Epidermal Thickness in µm (Metric) by Image Processing and Measurement at the Sternum (Control- Area) Skin thickness was measured in µm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). baseline
Secondary Epidermal Thickness in µm (Metric) by Image Processing and Measurement at the Sternum (Control- Area) Skin thickness was measured in µm (Metric) by Image Processing using Optical Coherence Tomography, OCT (Thorlabs, Lübeck, Germany). after two hours loading
Secondary Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany) at baseline
Secondary Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading TEWL was measured on sternum (control- area) using the Tewameter TM300 (Courage & Khazaka, Cologne, Germany). after two hours loading
Secondary Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. Baseline
Secondary Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C. after two hours loading
Secondary Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (? = 660 nm) and green (? = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. Baseline
Secondary Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading Erythema was measured with the Mexameter® MX 18 device by using specific wavelengths (the intensity of the reflected red (? = 660 nm) and green (? = 568 nm) lights) to measure the absorption capacity of the skin (specifically the content of hemoglobin in the skin). Lower values represent less redness. after two hours loading
Secondary Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. Baseline
Secondary Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading Corneometer® CM 825 (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure SCH in arbitrary units (AU) (range 0-120 AU). Lower values represent reduced skin hydration in the upper skin layer. after two hours loading
Secondary Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). Baseline
Secondary Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading Epidermal moisture (measurement depth 0,5mm) was measured using MoistureMeterEpiD (Delfin Technologies Ltd.). The values are expressed in percentage of local tissue water (0 to 100 %). after two hours loading
Secondary Skin Surface Mean Roughness (Rz) in µm at the Sternum (Control- Area), at Baseline Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. Baseline
Secondary Skin Surface Mean Roughness (Rz) in µm at the Sternum (Control- Area), After Two Hours Loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany) device. It consists of a UV light camera and measures the skin surface profiles. Rz is the arithmetic average of different segment roughness values calculated with visioscan software. The median was calculated from the Rz values from the 15 participants for each Intervention Group. after two hours loading
Secondary Skin Surface Mean Roughness (Ra) in µm at the Sternum (Control- Area), at Baseline Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. Baseline
Secondary Skin Surface Mean Roughness (Ra) in µm at the Sternum (Control- Area), After Two Hours Loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Ra is the arithmetical mean roughness calculated with visioscan software. The median was calculated from the Ra values from the 15 participants for each Intervention Group. after two hours loading
Secondary Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. Baseline
Secondary Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading Skin roughness was measured using the Visioscan VC98 (Courage+Khazaka, Cologne, Germany). It consists of a UV light camera and measures the skin surface profiles. Rmax (Maximum roughness) is the biggest roughness of the different segment roughness values. after two hours loading
Secondary Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). Baseline
Secondary Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading Skin extensibility was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm diameter and expressed in terms of total extensibility of the skin in mm (Uf, mm). after two hours loading
Secondary Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. Baseline
Secondary Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading The elastic function (Ur/Ue) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. after two hours loading
Secondary Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. Baseline
Secondary Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading The elastic recovery (elastic recovery (Ur) / maximum extension (Uf)) of the skin was measured using the Cutometer® MPA 580 and the corresponding software (Courage & Khazaka Electronic GmbH, Cologne, Germany).The measurements were conducted whit a pressure of -450 mBar and a probe opening of 2 mm Diameter. after two hours loading
See also
  Status Clinical Trial Phase
Completed NCT02224404 - Post Market Clinical Follow-up Investigation to Evaluate Performance and Safety on Pressure Ulcers, PU, When Using Exufiber as Intended N/A
Completed NCT01965444 - A Test of the Investigational SEM Scanner N/A
Withdrawn NCT00623948 - Implanted Gluteal Stimulation System for Pressure Sore Prevention N/A
Terminated NCT01433159 - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury Phase 2
Recruiting NCT01355666 - Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting N/A
Completed NCT01403272 - Evaluate the Efficacy of a Silk-Like Fabric for the Prevention of Pressure Sores in a Long Term Care Setting N/A
Completed NCT00971048 - Evaluation of the Effects of HP828-101 Versus Standard of Care in the Management of Partial or Full Thickness Wounds N/A
Completed NCT01008254 - Interdisciplinary Mobility Approach To Reduction Of Facility-Acquired Pressure Ulcers Phase 2/Phase 3
Terminated NCT00762138 - The AutoloGel™ Post-Market Surveillance (TAPS) Program N/A
Completed NCT00507650 - Increasing Fluids in Older Adults to Prevent & Treat Pressure Ulcers N/A
Completed NCT01877681 - Reference Nurse Program for Pressure Ulcers in Primary Care Phase 2
Completed NCT01232764 - Pressure Ulcer Multi-disciplinary Teams Via Telemedicine (PUMTT): A Trial in Long Term Care Phase 3
Completed NCT06374563 - Tackling Pressure Ulcer Via Bee Venom Phonophoresis N/A
Completed NCT03070925 - Prospective PuraPly™ AM Case Series Study N/A
Completed NCT02894437 - Qualitative Study of Preventive Organization of the Pelvic Bedsores Injured Spinal Cord
Completed NCT01348581 - Use of Fish Skin Extracellular Matrix (ECM) to Facilitate Chronic Wound Healing N/A
Completed NCT00771238 - Pilot Study of Incidence and Change in Existing Pressure Ulcers: TC500 Bed Compared With Standard Beds N/A
Completed NCT00763282 - Self-Management to Prevent Ulcers in Veterans With SCI (Spinal Cord Injury) N/A
Completed NCT01885962 - Development and Feasibility of an Internet Intervention for Adults With Spinal Cord Injury to Prevent Pressure Ulcers N/A
Completed NCT00382174 - Study of Thymosin Beta 4 in Patients With Pressure Ulcers Phase 2