Low Friction Bed Sheet

Study Overview
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Brief Summary
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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.

Official Title
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Does a Low Friction Bed Sheet Optimize the Skin, Resistance and Physiology and Reduce the Risk for Pressure Ulcer?

Conditions
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Spinal Cord Injury, Pressure Ulcer

Intervention / Treatment
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* Device: new bedsheet
* Device: conventional bedsheet


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: new bedsheet<br>new bedsheet | Device: new bedsheet<br>* sleeping 5 nights on the new bedsheet<br>* Other names: specially developed low-friction hospital bed sheet;|
| Placebo Comparator: conventional bedsheet<br>conventional bedsheet | Device: conventional bedsheet<br>* sleeping 5 nights on the conventional bedsheet<br>* Other names: normal hospital bedsheet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| well-being | linear questionnaire (visual analogue scale) | 1 day in the morning after sleeping on the new bed sheet | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin redness | Measurement: Mexameter 10 points of measurement in the sacral region | 1 day in the morning after sleeping on the new bed sheet | 
| Skin perfusion | Measurement: PeriFlux 10 points of measurement in the sacral region | 1 day in the morning after sleeping on the new bed sheet | 
| Skin hydration | Measurement: Corneometer 10 points of measurement in the sacral region | 1 day in the morning after sleeping on the new bed sheet | 
| Skin elasticity | Measurement: Cutometer 10 points of measurement in the sacral region | 1 day in the morning after sleeping on the new bed sheet |