Low Friction Bed Sheet

November 21, 2016 updated by: Swiss Paraplegic Centre Nottwil

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Lucerne
      • Nottwil, Lucerne, Switzerland, 6207
        • Swiss Paraplegic-Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: new bedsheet
Device: new bedsheet
sleeping 5 nights on the new bedsheet
Other Names:
  • specially developed low-friction hospital bed sheet
Placebo Comparator: conventional bedsheet
Device: conventional bedsheet
sleeping 5 nights on the conventional bedsheet
Other Names:
  • normal hospital bedsheet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
well-being
Time Frame: 1 day in the morning after sleeping on the new bed sheet
linear questionnaire (visual analogue scale)
1 day in the morning after sleeping on the new bed sheet

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin redness
Time Frame: 1 day in the morning after sleeping on the new bed sheet
Measurement: Mexameter 10 points of measurement in the sacral region
1 day in the morning after sleeping on the new bed sheet
Skin perfusion
Time Frame: 1 day in the morning after sleeping on the new bed sheet
Measurement: PeriFlux 10 points of measurement in the sacral region
1 day in the morning after sleeping on the new bed sheet
Skin hydration
Time Frame: 1 day in the morning after sleeping on the new bed sheet
Measurement: Corneometer 10 points of measurement in the sacral region
1 day in the morning after sleeping on the new bed sheet
Skin elasticity
Time Frame: 1 day in the morning after sleeping on the new bed sheet
Measurement: Cutometer 10 points of measurement in the sacral region
1 day in the morning after sleeping on the new bed sheet

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Paraplegic Centre Nottwil

Collaborators

Swiss Federal Laboratories for Material Sciences and Technology

Investigators

  • Principal Investigator: Anke Scheel, MD, Swiss Paraplegic Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 13, 2013

First Posted (Estimate)

September 16, 2013

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 21, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-04 (AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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