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Completed

NCT Number: NCT01943201

Low Friction Bed Sheet

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Paraplegic-Centre

Nottwil, Canton of Lucerne, 6207, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

new bedsheet

Device

sleeping 5 nights on the new bedsheet

Other names: specially developed low-friction hospital bed sheet

conventional bedsheet

Device

sleeping 5 nights on the conventional bedsheet

Other names: normal hospital bedsheet

Primary outcomes

  1. well-being

    Time frame: 1 day in the morning after sleeping on the new bed sheet

    linear questionnaire (visual analogue scale)

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Collaborators

  • Swiss Federal Laboratories for Material Sciences and Technology

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2013
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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