Pressure UlcersNCT02930590
Effects of Different Support Surfaces on the Properties Skin After Loading
A study testing Alternating low pressure mattress with air loss function, Gel mattress and Basic foam in people with Pressure Ulcers, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcers
- What is being tested?
- Alternating low pressure mattress with air loss function, Gel mattress and Basic foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effects of Three Different Support Surfaces on the Properties of Heel and Sacral 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).
- Conditions
- Pressure Ulcers
- Being tested
- Alternating low pressure mattress with air loss function, Gel mattress, Basic foam
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternating low pressure mattress with air loss functionOther
IsoAir, Stryker, USA
Gel mattressOther
IsoGel, Stryker, USA
Basic foamOther
Standard hospital mattress
| Study group | Role | What they receive |
|---|---|---|
| Low Pressure mattress | Experimental | Alternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA) Receives: Other: Alternating low pressure mattress with air loss function |
| Reactive support surface | Experimental | Gel mattress (IsoGel, stryker, USA) Receives: Other: Gel mattress |
| Standard mattress | Active comparator | basic foam Receives: Other: Basic foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
Measured: at baseline
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).
Measured: after two hours loading
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).
Measured: 20 min after off-loading
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline
TEWL was measured using the Tewameter TM300 (Courage \& Khazaka, Cologne, Germany).
Measured: at baseline
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).
Measured: after two hours loading
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).
Measured: 20 min after off-loading
Secondary outcomes (88)
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.
Measured: at baseline
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.
Measured: after two hours
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.
Measured: 20 minutes after off-loading
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.
Measured: at baseline
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.
Measured: after two hours loading
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.
Measured: 20 minutes after off-loading
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.
Measured: at baseline
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.
Measured: after two hours loading
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.
Measured: 20 min after off-loading
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.
Measured: at baseline
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.
Measured: after two hours loading
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.
Measured: 20 min after off-loading
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.
Measured: at baseline
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.
Measured: after two hours loading
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.
Measured: 20 min after off-loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: 20 min after off-loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: 20 min after off-loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: 20 min after off-loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: 20 minutes after off-loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: 20 min after off-loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: 20 min after off-loading
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.
Measured: after two hours loading
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.
Measured: Baseline
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.
Measured: 20 minutes after off-loading
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).
Measured: Baseline
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).
Measured: after two hours loading
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).
Measured: 20 minutes after off-loading
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).
Measured: Baseline
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).
Measured: after two hours loading
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).
Measured: 20 minutes after off-loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: 20 minutes after off-loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: 20 minutes after off-loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: 20 minutes after off-loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: 20 minutes after off-loading
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 %).
Measured: Baseline
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 %).
Measured: after two hours loading
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 %).
Measured: 20 minutes after off-loading
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 %).
Measured: Baseline
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 %).
Measured: after two hours loading
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 %).
Measured: 20 minutes after off-loading
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).
Measured: Baseline
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).
Measured: after two hours loading
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).
Measured: baseline
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).
Measured: after two hours loading
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).
Measured: baseline
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).
Measured: after two hours loading
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)
Measured: at baseline
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).
Measured: after two hours loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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 %).
Measured: Baseline
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 %).
Measured: after two hours loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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).
Measured: Baseline
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).
Measured: after two hours loading
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.
Measured: Baseline
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.
Measured: after two hours loading
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.
Measured: Baseline
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.
Measured: after two hours loading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Jan Kottner, Charite University, Berlin, Germany
- Investigators
- Jan Kottner, PD Dr., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02930590
- Sponsor's protocol ID
- CRC-PU-A-23
- Status last verified
- May 2022
- First submitted
- 26 Sep 2016
- Last updated
- 14 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29277963
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effects of Three Different Support Surfaces on the Properties of Heel and Sacral Skin After Loading
- ClinicalTrials.gov ID
- NCT02930590
- Acronym / sponsor ID
- CRC-PU-A-23
- Conditions
- Pressure Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 12 Oct 2016 (estimated)
- Results
- Posted 23 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Pressure mattress | Experimental | Other: Alternating low pressure mattress with air loss functionAlternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA) |
| Reactive support surface | Experimental | Other: Gel mattressGel mattress (IsoGel, stryker, USA) |
| Standard mattress | Active comparator | Other: Basic foambasic foam |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternating low pressure mattress with air loss functionIsoAir, Stryker, USA | Other | Low Pressure mattress |
| Gel mattressIsoGel, Stryker, USA | Other | Reactive support surface |
| Basic foamStandard hospital mattress | Other | Standard mattress |
Primary outcome
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).
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).
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).
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).
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).
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).
88 secondary outcomes
Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline
Time frame: at baseline
Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours
Time frame: after two hours
Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading
Time frame: 20 minutes after off-loading
Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline
Time frame: at baseline
Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading
Time frame: after two hours loading
Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading
Time frame: 20 minutes after off-loading
Erythema Index in Arbitrary Units at the Sacrum, at Baseline
Time frame: at baseline
Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading
Time frame: after two hours loading
Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading
Time frame: 20 min after off-loading
Erythema Index in Arbitrary Units at the Heels, at Baseline
Time frame: at baseline
Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading
Time frame: after two hours loading
Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading
Time frame: 20 min after off-loading
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline
Time frame: at baseline
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading
Time frame: after two hours loading
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading
Time frame: 20 min after off-loading
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline
Time frame: Baseline
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading
Time frame: after two hours loading
Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading
Time frame: 20 min after off-loading
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline
Time frame: Baseline
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading
Time frame: after two hours loading
Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading
Time frame: 20 min after off-loading
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline
Time frame: Baseline
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading
Time frame: after two hours loading
Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading
Time frame: 20 min after off-loading
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline
Time frame: Baseline
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading
Time frame: after two hours loading
Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading
Time frame: 20 minutes after off-loading
Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline
Time frame: Baseline
Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading
Time frame: after two hours loading
Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading
Time frame: 20 min after off-loading
Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline
Time frame: Baseline
Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading
Time frame: after two hours loading
Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading
Time frame: 20 min after off-loading
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading
Time frame: after two hours loading
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline
Time frame: Baseline
Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading
Time frame: 20 minutes after off-loading
Skin Extensibility (Uf) in mm at the Sacrum, at Baseline
Time frame: Baseline
Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading
Time frame: after two hours loading
Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading
Time frame: 20 minutes after off-loading
Skin Extensibility (Uf) in mm at the Heel, at Baseline
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29277963Tomova-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.
Related trials for Pressure Ulcers
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Not yet recruiting
Pulsed High Intensity Laser Versus Negative Pressure Therapy On Neuropathic Ulcers
Neuropathic Ulcers
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
Dementia, Home Care for Elderly or Disabled Individuals
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Kottner, PD Dr. study director
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternating low pressure mattress with air loss function, Gel mattress and Basic foam in people with Pressure Ulcers, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline (time frame: at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02930590, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.