Effects of Different Support Surfaces on the Properties Skin After Loading (NCT02930590) | Clinical Trial Compass
CompletedNot Applicable
Effects of Different Support Surfaces on the Properties Skin After Loading
Germany15 participantsStarted 2016-09
Plain-language 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).
Who can participate
Age range
60 Years – 80 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, at Baseline
Timeframe: at baseline
2
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, After Two Hours Loading
Timeframe: after two hours loading
3
Transepidermal Water Loss (TEWL) in g/m2/h on Sacrum, 20 Min After Off-loading
Timeframe: 20 min after off-loading
4
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, at Baseline
Timeframe: at baseline
5
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, After Two Hours Loading
Timeframe: after two hours loading
6
Transepidermal Water Loss (TEWL) in g/m2/h on Heel, 20 Min After Off-loading