Low Friction Bed Sheet
Does a Low Friction Bed Sheet Optimize the Skin, Resistance and Physiology and Reduce the Risk for Pressure Ulcer?
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 11, 2013
CompletedFirst Posted
Study publicly available on registry
September 16, 2013
CompletedNovember 22, 2016
November 1, 2016
2.9 years
September 11, 2013
November 21, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
well-being
linear questionnaire (visual analogue scale)
1 day in the morning after sleeping on the new bed sheet
Secondary Outcomes (4)
Skin redness
1 day in the morning after sleeping on the new bed sheet
Skin perfusion
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
Study Arms (2)
new bedsheet
EXPERIMENTALnew bedsheet
conventional bedsheet
PLACEBO COMPARATORconventional bedsheet
Interventions
sleeping 5 nights on the new bedsheet
sleeping 5 nights on the conventional bedsheet
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- progressive disease
- severe accessory symptoms (diabetes mellitus, coronary heart disease, severe renal failure)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Swiss Paraplegic-Centre
Nottwil, Canton of Lucerne, 6207, Switzerland
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anke Scheel, MD
Swiss Paraplegic Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2013
First Posted
September 16, 2013
Study Start
January 1, 2010
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
November 22, 2016
Record last verified: 2016-11