Effects of Different Support Surfaces on the Properties Skin After Loading

Charité University Medicine Berlin

Status: Completed

Conditions: Pressure Ulcers

Treatments: Other: Gel mattress; Other: Basic foam; Other: Alternating low pressure mattress with air loss function

Study type: Interventional

Funder types: Other

Identifiers

NCT02930590

CRC-PU-A-23

Details and patient eligibility

About

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).

Enrollment: 15 patients

Sex: Female

Ages: 60 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Low Pressure mattress

Experimental group

Description:

Alternating Low Pressure mattress with low air loss function (IsoAir, stryker, USA)

Treatment:

Other: Alternating low pressure mattress with air loss function

Reactive support surface

Experimental group

Description:

Gel mattress (IsoGel, stryker, USA)

Treatment:

Other: Gel mattress

Standard mattress

Active Comparator group

Description:

basic foam

Treatment:

Other: Basic foam