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Low Friction Bed Sheet

NCT01943201 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-11-22

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury
  • Pressure Ulcer

Interventions

DEVICE

new bedsheet

sleeping 5 nights on the new bedsheet

DEVICE

conventional bedsheet

sleeping 5 nights on the conventional bedsheet

Sponsors & Collaborators

  • Swiss Federal Laboratories for Material Sciences and Technology

    collaborator UNKNOWN

  • Swiss Paraplegic Research, Nottwil

    lead NETWORK

Principal Investigators

  • Anke Scheel, MD · Swiss Paraplegic Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01943201 on ClinicalTrials.gov