Low Friction Bed Sheet

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943201
• Other study ID #: 2010-04
• Status: Completed
• Phase: N/A
• First received: September 11, 2013
• Last updated: November 21, 2016
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: November 2016
• Source: Swiss Paraplegic Centre Nottwil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pressure Ulcer
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Device:
• new bedsheet
sleeping 5 nights on the new bedsheet
• conventional bedsheet
sleeping 5 nights on the conventional bedsheet

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic-Centre	Nottwil	Lucerne

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Paraplegic Centre Nottwil	Swiss Federal Laboratories for Material Sciences and Technology

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	well-being	linear questionnaire (visual analogue scale)	1 day in the morning after sleeping on the new bed sheet	No
Secondary	Skin redness	Measurement: Mexameter 10 points of measurement in the sacral region	1 day in the morning after sleeping on the new bed sheet	No
Secondary	Skin perfusion	Measurement: PeriFlux 10 points of measurement in the sacral region	1 day in the morning after sleeping on the new bed sheet	No
Secondary	Skin hydration	Measurement: Corneometer 10 points of measurement in the sacral region	1 day in the morning after sleeping on the new bed sheet	No
Secondary	Skin elasticity	Measurement: Cutometer 10 points of measurement in the sacral region	1 day in the morning after sleeping on the new bed sheet	No

External Links

•   Swiss Paraplegic Centre Nottwil