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Low Friction Bed Sheet

Primary Purpose

Spinal Cord Injury, Pressure Ulcer

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
new bedsheet
conventional bedsheet
Sponsored by
Swiss Paraplegic Research, Nottwil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Swiss Paraplegic-Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

new bedsheet

conventional bedsheet

Arm Description

new bedsheet

conventional bedsheet

Outcomes

Primary Outcome Measures

well-being
linear questionnaire (visual analogue scale)

Secondary Outcome Measures

Skin redness
Measurement: Mexameter 10 points of measurement in the sacral region
Skin perfusion
Measurement: PeriFlux 10 points of measurement in the sacral region
Skin hydration
Measurement: Corneometer 10 points of measurement in the sacral region
Skin elasticity
Measurement: Cutometer 10 points of measurement in the sacral region

Full Information

First Posted
September 11, 2013
Last Updated
November 21, 2016
Sponsor
Swiss Paraplegic Research, Nottwil
Collaborators
Swiss Federal Laboratories for Material Sciences and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01943201
Brief Title
Low Friction Bed Sheet
Official Title
Does a Low Friction Bed Sheet Optimize the Skin, Resistance and Physiology and Reduce the Risk for Pressure Ulcer?
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Paraplegic Research, Nottwil
Collaborators
Swiss Federal Laboratories for Material Sciences and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Pressure Ulcer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
new bedsheet
Arm Type
Experimental
Arm Description
new bedsheet
Arm Title
conventional bedsheet
Arm Type
Placebo Comparator
Arm Description
conventional bedsheet
Intervention Type
Device
Intervention Name(s)
new bedsheet
Other Intervention Name(s)
specially developed low-friction hospital bed sheet
Intervention Description
sleeping 5 nights on the new bedsheet
Intervention Type
Device
Intervention Name(s)
conventional bedsheet
Other Intervention Name(s)
normal hospital bedsheet
Intervention Description
sleeping 5 nights on the conventional bedsheet
Primary Outcome Measure Information:
Title
well-being
Description
linear questionnaire (visual analogue scale)
Time Frame
1 day in the morning after sleeping on the new bed sheet
Secondary Outcome Measure Information:
Title
Skin redness
Description
Measurement: Mexameter 10 points of measurement in the sacral region
Time Frame
1 day in the morning after sleeping on the new bed sheet
Title
Skin perfusion
Description
Measurement: PeriFlux 10 points of measurement in the sacral region
Time Frame
1 day in the morning after sleeping on the new bed sheet
Title
Skin hydration
Description
Measurement: Corneometer 10 points of measurement in the sacral region
Time Frame
1 day in the morning after sleeping on the new bed sheet
Title
Skin elasticity
Description
Measurement: Cutometer 10 points of measurement in the sacral region
Time Frame
1 day in the morning after sleeping on the new bed sheet

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anke Scheel, MD
Organizational Affiliation
Swiss Paraplegic Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Swiss Paraplegic-Centre
City
Nottwil
State/Province
Lucerne
ZIP/Postal Code
6207
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
http://www.paraplegie.ch
Description
Swiss Paraplegic Centre Nottwil

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Low Friction Bed Sheet

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