Pressure Ulcer, Spinal Cord Injury
Conditions
Brief summary
Introduction: It is known that people with spinal cord injury (SCI) bear a considerably increased risk of developing pressure ulcer, whereby frictional forces and shear forces are recognized as risk factors. It was the aim of the study to examine the effects of a specially developed low-friction hospital bed sheet on skin physiology as well as it's acceptance by patients with SCI. Method: Prospective, randomised crossover study. Patients with a subacute spinal cord injury will be recruited. Each patient spends five consecutive nights on the new, respectively, conventional bed sheet. After the five nights, patients are asked to complete a linear questionnaire (VAS) concerning well-being, odour, perspiration and wrinkling. In addition, the patients are examined daily while still fasting, for skin redness, skin moisture, skin elasticity and skin blood circulation in the parasacral region.
Interventions
DEVICEnew bedsheet
sleeping 5 nights on the new bedsheet
DEVICEconventional bedsheet
sleeping 5 nights on the conventional bedsheet
Sponsors
Swiss Federal Laboratories for Material Sciences and Technology
Swiss Paraplegic Research, Nottwil
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* SCI patients without a presser ulcer for the last 2 months * Paraplegic and tetraplegic patients * complete and incomplete lesion (AIS A, AIS B, AIS C, AIS D) * caused by illness or traumatic event * smoker and non-smoker
Exclusion criteria
* progressive disease * severe accessory symptoms (diabetes mellitus, coronary heart disease, severe renal failure)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| well-being | 1 day in the morning after sleeping on the new bed sheet | linear questionnaire (visual analogue scale) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin redness | 1 day in the morning after sleeping on the new bed sheet | Measurement: Mexameter 10 points of measurement in the sacral region |
| Skin perfusion | 1 day in the morning after sleeping on the new bed sheet | Measurement: PeriFlux 10 points of measurement in the sacral region |
| Skin hydration | 1 day in the morning after sleeping on the new bed sheet | Measurement: Corneometer 10 points of measurement in the sacral region |
| Skin elasticity | 1 day in the morning after sleeping on the new bed sheet | Measurement: Cutometer 10 points of measurement in the sacral region |
Countries
Switzerland
Outcome results
None listed