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Completed

NCT Number: NCT02930590

Effects of Different Support Surfaces on the Properties Skin After Loading

Pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide. There is common agreement, that effective pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. Besides risk assessment and repositioning the use of special pressure ulcer preventive support surfaces are the key interventions in pressure ulcer prevention. Pressure ulcer preventive support surface modify the degree of skin and tissue deformation and/or skin temperature and moisture. Therefore, an association between the type and working mechanism of a pressure ulcer support surface and skin function after loading is highly likely. Furthermore, such a relationship may be used to characterize and/or to quantify the performance pressure ulcer support surfaces in terms of skin protection. The overall aim of this explorative study is to measure skin responses of the two most common pressure ulcer predilection sites (heel, sacral skin) after two hours loading on three different support surfaces and the sternal skin (control area).

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Key information

Conditions

Pressure Ulcers Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

60 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Charité-Universitätsmedizin Berlin

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alternating low pressure mattress with air loss function

Other

IsoAir, Stryker, USA

Gel mattress

Other

IsoGel, Stryker, USA

Basic foam

Other

Standard hospital mattress

Primary outcomes

  1. Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline

    Time frame: at baseline

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

  2. Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading

    Time frame: after two hours loading

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

  3. Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading

    Time frame: 20 min after off-loading

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

  4. Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline

    Time frame: at baseline

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

  5. Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading

    Time frame: after two hours loading

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

  6. Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading

    Time frame: 20 min after off-loading

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

Secondary outcomes

  1. Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline

    Time frame: 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.

  2. Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours

    Time frame: 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.

  3. Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading

    Time frame: 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.

  4. Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline

    Time frame: 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.

  5. Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading

    Time frame: 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.

  6. Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading

    Time frame: 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.

  7. Erythema Index in Arbitrary Units at the Sacrum, at Baseline

    Time frame: 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.

  8. Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading

    Time frame: 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.

  9. Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading

    Time frame: 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.

  10. Erythema Index in Arbitrary Units at the Heels, at Baseline

    Time frame: 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.

  11. Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading

    Time frame: 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.

  12. Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading

    Time frame: 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.

  13. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline

    Time frame: 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.

  14. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading

    Time frame: 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.

  15. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading

    Time frame: 20 min after 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.

  16. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline

    Time frame: 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.

  17. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading

    Time frame: 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.

  18. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading

    Time frame: 20 min after 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.

  19. Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline

    Time frame: 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.

  20. Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading

    Time frame: 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.

  21. Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading

    Time frame: 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.

  22. Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline

    Time frame: 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.

  23. Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading

    Time frame: 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.

  24. Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading

    Time frame: 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.

  25. Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline

    Time frame: 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.

  26. Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading

    Time frame: 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.

  27. Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading

    Time frame: 20 minutes 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.

  28. Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline

    Time frame: 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.

  29. Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading

    Time frame: 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.

  30. Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading

    Time frame: 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.

  31. Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline

    Time frame: 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.

  32. Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading

    Time frame: 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.

  33. Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading

    Time frame: 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.

  34. Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading

    Time frame: 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.

  35. Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline

    Time frame: 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.

  36. Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading

    Time frame: 20 minutes 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.

  37. Skin Extensibility (Uf) in mm at the Sacrum, at Baseline

    Time frame: 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).

  38. Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading

    Time frame: 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).

  39. Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading

    Time frame: 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).

  40. Skin Extensibility (Uf) in mm at the Heel, at Baseline

    Time frame: 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).

  41. Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading

    Time frame: 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).

  42. Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading

    Time frame: 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).

  43. Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline

    Time frame: 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.

  44. Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading

    Time frame: 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.

  45. Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading

    Time frame: 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.

  46. Elastic Recovery (Ur/Uf) at the Heel, at Baseline

    Time frame: 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.

  47. Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading

    Time frame: 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.

  48. Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading

    Time frame: 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.

  49. Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline

    Time frame: 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.

  50. Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading

    Time frame: 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.

  51. Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading

    Time frame: 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.

  52. Skin Elastic Function (Ur/Ue) at the Heel, at Baseline

    Time frame: 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.

  53. Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading

    Time frame: 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.

  54. Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading

    Time frame: 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.

  55. Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline

    Time frame: 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 %).

  56. Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading

    Time frame: 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 %).

  57. Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading

    Time frame: 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 %).

  58. Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline

    Time frame: 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 %).

  59. Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading

    Time frame: 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 %).

  60. Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading

    Time frame: 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 %).

  61. Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum

    Time frame: Baseline

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

  62. Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum

    Time frame: after two hours loading

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

  63. Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel

    Time frame: baseline

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

  64. Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel

    Time frame: after two hours loading

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

  65. Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)

    Time frame: baseline

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

  66. Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area)

    Time frame: after two hours loading

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

  67. Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline

    Time frame: at baseline

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

  68. Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading

    Time frame: after two hours loading

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

  69. Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline

    Time frame: Baseline

    Skin thermometer based on the infrared technique (Courage & Khazaka electronic GmbH, Cologne, Germany) was used to measure the skin surface temperature in °C.

  70. Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading

    Time frame: 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.

  71. Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline

    Time frame: 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.

  72. Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading

    Time frame: 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.

  73. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline

    Time frame: 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.

  74. Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading

    Time frame: 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.

  75. Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline

    Time frame: 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 %).

  76. Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading

    Time frame: 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 %).

  77. Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline

    Time frame: 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.

  78. Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading

    Time frame: 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.

  79. Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline

    Time frame: 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.

  80. Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading

    Time frame: 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.

  81. Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline

    Time frame: 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.

  82. Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading

    Time frame: 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.

  83. Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline

    Time frame: 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).

  84. Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading

    Time frame: 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).

  85. Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline

    Time frame: 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.

  86. Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading

    Time frame: 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.

  87. Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline

    Time frame: 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.

  88. Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Comparing the Effects of Three Different Support Surfaces on the Properties of Heel and Sacral Skin After Loading

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 12, 2016
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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