N/A
N=15
Effects of Different Support Surfaces on the Properties Skin After Loading
Pressure Ulcers
Bottom Line
View on ClinicalTrials.gov: NCT02930590 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline — 7.8; 7.7; 7.1 g/m2/h
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Alternating low pressure mattress with air loss function (Other); Gel mattress (Other); Basic foam (Other)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- Female
- Sponsor
- Charite University, Berlin, Germany
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline |
7.8; 7.7; 7.1 | — |
| PRIMARY Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading |
12.4; 10.4; 14.5 | — |
| PRIMARY Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading |
8.0; 7.6; 8.0 | — |
| PRIMARY Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline |
8.1; 9.4; 8.6 | — |
| PRIMARY Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading |
19.5; 19.2; 28.4 | — |
| PRIMARY Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading |
9.6; 10.4; 11.1 | — |
| SECONDARY Skin Surface Temperature in °C Per Skin Area at the Sacrum, at Baseline |
28.8; 28.9; 29.1 | — |
| SECONDARY Skin Surface Temperature in °C Per Skin Area at the Sacrum, After Two Hours |
31.4; 30.7; 32.0 | — |
| SECONDARY Skin Surface Temperature in °C Per Skin Area at the Sacrum, 20 Minutes After Off-loading |
30.3; 29.4; 30.3 | — |
| SECONDARY Skin Surface Temperature in °C Per Skin Area at the Heel, at Baseline |
24.4; 25.2; 24.3 | — |
| SECONDARY Skin Surface Temperature in °C Per Skin Area at the Heel, After Two Hours Loading |
26.5; 25.5; 26.6 | — |
| SECONDARY Skin Surface Temperature in °C Per Skin Area at the Heel, 20 Minutes After Off-loading |
25.4; 25.2; 25.9 | — |
| SECONDARY Erythema Index in Arbitrary Units at the Sacrum, at Baseline |
187.5; 176.5; 167.2 | — |
| SECONDARY Erythema Index in Arbitrary Units at the Sacrum, After Two Hours Loading |
220.2; 206.0; 235.9 | — |
| SECONDARY Erythema Index in Arbitrary Units at the Sacrum, 20 Min After Off-loading |
201.3; 194.0; 221.0 | — |
| SECONDARY Erythema Index in Arbitrary Units at the Heels, at Baseline |
194.5; 177.9; 186.2 | — |
| SECONDARY Erythema Index in Arbitrary Units at the Heels, After Two Hours Loading |
247.1; 225.7; 225.2 | — |
| SECONDARY Erythema Index in Arbitrary Units at the Heels, 20 Min After Off-loading |
231.9; 188.5; 226.7 | — |
| SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, at Baseline |
27.2; 23.8; 27.5 | — |
| SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, After Two Hours Loading |
34.6; 29.8; 31.6 | — |
| SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sacrum, 20 Min Off-loading |
29.3; 27.4; 30.1 | — |
| SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, at Baseline |
13.3; 13.6; 12.9 | — |
| SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, After Two Hours Loading |
18.0; 17.9; 20.2 | — |
| SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Heels, 20min Off-loading |
14.4; 12.9; 15.3 | — |
| SECONDARY Skin Surface Mean Roughness (Rz) in μm at the Sacrum, at Baseline |
39.5; 35.5; 34.0 | — |
| SECONDARY Skin Surface Mean Roughness (Rz) in μm at the Sacrum, After Two Hours Loading |
39.0; 40.0; 39.5 | — |
| SECONDARY Skin Surface Mean Roughness (Rz) in μm at the Sacrum, 20 Min After Off-loading |
43.0; 40.5; 42.5 | — |
| SECONDARY Skin Surface Mean Roughness (Ra) in μm at the Sacrum, at Baseline |
9.0; 8.3; 8.0 | — |
| SECONDARY Skin Surface Mean Roughness (Ra) in μm at the Sacrum, After Two Hours Loading |
9.0; 9.0; 8.5 | — |
| SECONDARY Skin Surface Mean Roughness (Ra) in μm at the Sacrum, 20 Min Off-loading |
10.0; 9.5; 9.0 | — |
| SECONDARY Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, at Baseline |
51.0; 47.5; 46.5 | — |
| SECONDARY Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, After Two Hours Loading |
51.0; 50.0; 52.0 | — |
| SECONDARY Skin Surface Maximum Roughness (Rmax) in µm at the Sacrum, 20 Min Off-loading |
57.0; 52.5; 52.0 | — |
| SECONDARY Skin Surface Mean Roughness (Rz) in μm at the Heel, at Baseline |
48.5; 48.3; 51.5 | — |
| SECONDARY Skin Surface Mean Roughness (Rz) in μm at the Heels, After Two Hours Loading |
50.5; 51.5; 51.0 | — |
| SECONDARY Skin Surface Mean Roughness (Rz) in μm at the Heels, 20min Off-loading |
52.5; 59.5; 55.0 | — |
| SECONDARY Skin Surface Mean Roughness (Ra) in μm at the Heels, at Baseline |
9.0; 9.8; 9.5 | — |
| SECONDARY Skin Surface Mean Roughness (Ra) in μm at the Heels, After Two Hours Loading |
10.0; 10.0; 8.5 | — |
| SECONDARY Skin Surface Mean Roughness (Ra) in μm at the Heels, 20 Min After Off-loading |
10.5; 11.5; 9.0 | — |
| SECONDARY Skin Surface Maximum Roughness (Rmax) in µm at the Heel, After Two Hours Loading |
67.5; 73.5; 67.5 | — |
| SECONDARY Skin Surface Maximum Roughness (Rmax) in µm at the Heel, at Baseline |
63.5; 63.8; 70.0 | — |
| SECONDARY Skin Surface Maximum Roughness (Rmax) in µm at the Heel, 20 Min After Off-loading |
71.5; 81.5; 70.0 | — |
| SECONDARY Skin Extensibility (Uf) in mm at the Sacrum, at Baseline |
0.32; 0.29; 0.32 | — |
| SECONDARY Skin Extensibility (Uf) in mm at the Sacrum, After Two Hours Loading |
0.34; 0.32; 0.35 | — |
| SECONDARY Skin Extensibility (Uf) in mm at the Sacrum, 20 Minutes After Off-loading |
0.33; 0.31; 0.32 | — |
| SECONDARY Skin Extensibility (Uf) in mm at the Heel, at Baseline |
0.08; 0.08; 0.09 | — |
| SECONDARY Skin Extensibility (Uf) in mm at the Heel, After Two Hours Loading |
0.10; 0.10; 0.10 | — |
| SECONDARY Skin Extensibility (Uf) in mm at the Heel, 20 Minutes After Off-loading |
0.08; 0.09; 0.10 | — |
| SECONDARY Elastic Recovery (Ur/Uf) at the Sacrum, at Baseline |
0.55; 0.52; 0.57 | — |
| SECONDARY Elastic Recovery (Ur/Uf) at the Sacrum, After Two Hours Loading |
0.55; 0.50; 0.44 | — |
| SECONDARY Elastic Recovery (Ur/Uf) at the Sacrum, 20 Minutes After Off-loading |
0.52; 0.45; 0.51 | — |
| SECONDARY Elastic Recovery (Ur/Uf) at the Heel, at Baseline |
0.36; 0.35; 0.35 | — |
| SECONDARY Elastic Recovery (Ur/Uf) at the Heel, After Two Hours Loading |
0.35; 0.36; 0.38 | — |
| SECONDARY Elastic Recovery (Ur/Uf) at the Heel, 20 Minutes After Off-loading |
0.34; 0.36; 0.35 | — |
| SECONDARY Skin Elastic Function (Ur/Ue) at the Sacrum, at Baseline |
0.79; 0.78; 0.80 | — |
| SECONDARY Skin Elastic Function (Ur/Ue) at the Sacrum, After Two Hours Loading |
0.81; 0.70; 0.65 | — |
| SECONDARY Skin Elastic Function (Ur/Ue) at the Sacrum, 20 Minutes After Off-loading |
0.75; 0.66; 0.72 | — |
| SECONDARY Skin Elastic Function (Ur/Ue) at the Heel, at Baseline |
0.67; 0.68; 0.68 | — |
| SECONDARY Skin Elastic Function (Ur/Ue) at the Heel, After Two Hours Loading |
0.66; 0.70; 0.70 | — |
| SECONDARY Skin Elastic Function (Ur/Ue) at the Heel, 20 Minutes After Off-loading |
0.67; 0.67; 0.67 | — |
| SECONDARY Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, at Baseline |
41.0; 40.0; 41.0 | — |
| SECONDARY Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, After Two Hours Loading |
44.5; 41.5; 43.5 | — |
| SECONDARY Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sacrum, 20 Minutes After Off-loading |
44.5; 42.5; 44.0 | — |
| SECONDARY Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, at Baseline |
25.5; 25.5; 24.0 | — |
| SECONDARY Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, After Two Hours Loading |
28.0; 25.5; 28.0 | — |
| SECONDARY Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Heel, 20 Minutes After Off-loading |
25.5; 25.5; 25.5 | — |
| SECONDARY Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum |
0.08 | — |
| SECONDARY Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sacrum |
0.08 | — |
| SECONDARY Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel |
0.45 | — |
| SECONDARY Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Heel |
0.45 | — |
| SECONDARY Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area) |
0.08 | — |
| SECONDARY Epidermal Thickness in μm (Metric) by Image Processing and Measurement at the Sternum (Control- Area) |
0.08 | — |
| SECONDARY Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), at Baseline |
10.4; 9.8; 9.8 | — |
| SECONDARY Transepidermal Water Loss (TEWL) in g/m2/h on Sternum (Control- Area), After Two Hours Loading |
8.3; 8.0; 8.1 | — |
| SECONDARY Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), at Baseline |
30.8; 30.7; 30.9 | — |
| SECONDARY Skin Surface Temperature in °C Per Skin Area at the Sternum (Control- Area), After Two Hours Loading |
29.9; 30.2; 30.6 | — |
| SECONDARY Erythema Index in Arbitrary Units at the Sternum (Control- Area), at Baseline |
317.7; 342; 390.2 | — |
| SECONDARY Erythema Index in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading |
344.2; 350.2; 325.9 | — |
| SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), at Baseline |
48.1; 50.0; 47.0 | — |
| SECONDARY Stratum Corneum Hydration (SCH) in Arbitrary Units at the Sternum (Control- Area), After Two Hours Loading |
46.7; 43.7; 44.3 | — |
| SECONDARY Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), at Baseline |
50.0; 52.0; 51.5 | — |
| SECONDARY Epidermal Moisture Measurements Per Skin Area in Percentage (%) at the Sternum (Control- Area), After Two Hours Loading |
45.5; 51.5; 51.5 | — |
| SECONDARY Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), at Baseline |
36.5; 37.8; 35.0 | — |
| SECONDARY Skin Surface Mean Roughness (Rz) in μm at the Sternum (Control- Area), After Two Hours Loading |
29.0; 28.5; 28.0 | — |
| SECONDARY Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), at Baseline |
8.0; 7.3; 8.5 | — |
| SECONDARY Skin Surface Mean Roughness (Ra) in μm at the Sternum (Control- Area), After Two Hours Loading |
7.0; 7.0; 7.0 | — |
| SECONDARY Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), at Baseline |
48.5; 49.0; 44.5 | — |
| SECONDARY Skin Surface Maximum Roughness (Rmax) in µm at the Sternum (Control- Area), After Two Hours Loading |
38.5; 38.5; 36.0 | — |
| SECONDARY Skin Extensibility (Uf) in mm at the Sternum (Control- Area), at Baseline |
0.34; 0.32; 0.36 | — |
| SECONDARY Skin Extensibility (Uf) in mm at the Sternum (Control- Area), After Two Hours Loading |
0.32; 0.32; 0.37 | — |
| SECONDARY Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), at Baseline |
0.59; 0.32; 0.70 | — |
| SECONDARY Skin Elastic Function (Ur/Ue) at the Sternum (Control- Area), After Two Hours Loading |
0.71; 0.32; 0.68 | — |
| SECONDARY Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), at Baseline |
0.42; 0.43; 0.47 | — |
| SECONDARY Elastic Recovery (Ur/Uf) at the Sternum (Control- Area), After Two Hours Loading |
0.47; 0.48; 0.43 | — |
Summary
Pressure ulcers are severe injuries and wounds causing a substantial burden on patients, caregivers, and on healthcare systems worldwide. There is common agreement, that effective pressure ulcer prevention is of crucial importance to maintain skin and tissue integrity in individuals at risk. Besides risk assessment and repositioning the use of special pressure ulcer preventive support surfaces are the key interventions in pressure ulcer prevention. Pressure ulcer preventive support surface modify the degree of skin and tissue deformation and/or skin temperature and moisture. Therefore, an association between the type and working mechanism of a pressure ulcer support surface and skin function after loading is highly likely. Furthermore, such a relationship may be used to characterize and/or to quantify the performance pressure ulcer support surfaces in terms of skin protection. The overall aim of this explorative study is to measure skin responses of the two most common pressure ulcer predilection sites (heel, sacral skin) after two hours loading on three different support surfaces and the sternal skin (control area).
Eligibility Criteria
Inclusion Criteria
- Healthy, female volunteers
- 60 to 80 years
- Body Mass Index between 18.5 and 29.9 kg/m2
- Non-Smoker of at least one year
- Absence of skin diseases or scars in the skin areas of interest
- Ability to move independently and to maintain supine and prone positions
- Able to give written informed consent
- No use of cosmetic products or topical applied drugs on the study areas at least 12 hours before measurement
- Skin phototype I to III according to Fitzpatrick classification
- Willing and able to fulfil the study requirements
Exclusion Criteria
- Disability to maintain in supine or prone position
- Acute diseases
- Acute or chronic diseases with increased or decreased body temperature (≤ 35°C or ≥ 38,5°C, measured in the ear)
- History or establishment of Diabetes or pre-diabetes, cardiac or renal insufficiency, atopic dermatitis, psoriasis, chronic obstructive pulmonary disease (COPD)
- Acute or chronic wounds in the skin areas of interest
- Any skin affection which may interfere with the study assessment, e.g. tattoo, psoriasis or scar on the investigational sites
- Participation in another clinical study 4 weeks before inclusion visit
- Current participation in any other clinical study
Data sourced from ClinicalTrials.gov (NCT02930590). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.