Does a Low Friction Bed Sheet Optimize the Skin, Resistance and Physiology and Reduce the Risk for Pressure Ulcer?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- well-being
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
new bedsheet
new bedsheet
Intervention: new bedsheet (Device)
conventional bedsheet
conventional bedsheet
Intervention: conventional bedsheet (Device)
Outcomes
Primary Outcomes
well-being
Time Frame: 1 day in the morning after sleeping on the new bed sheet
linear questionnaire (visual analogue scale)
Secondary Outcomes
- Skin perfusion(1 day in the morning after sleeping on the new bed sheet)
- Skin redness(1 day in the morning after sleeping on the new bed sheet)
- Skin hydration(1 day in the morning after sleeping on the new bed sheet)
- Skin elasticity(1 day in the morning after sleeping on the new bed sheet)