Low Friction Bed Sheet

Swiss Paraplegic Research, Nottwil

Status: Completed

Conditions: Pressure Ulcer; Spinal Cord Injury

Treatments: Device: new bedsheet; Device: conventional bedsheet

Study type: Interventional

Funder types: NETWORK; Other

Identifiers

NCT01943201

2010-04

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups, including a placebo group

new bedsheet

Experimental group

Description:

new bedsheet

Treatment:

Device: new bedsheet

conventional bedsheet

Placebo Comparator group

Description:

conventional bedsheet

Treatment:

Device: conventional bedsheet