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Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00262444
Recruitment Status : Completed
First Posted : December 6, 2005
Last Update Posted : December 28, 2007
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.

Condition or disease Intervention/treatment
Pressure Ulcer Lesions (Grade 2 or More) Procedure: Different turning frequencies

Detailed Description:
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
Study Start Date : September 2003
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pressure Sores
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Incidence of pressure ulcers [ Time Frame: during 5 weeks ]
  2. Time to develop pressure ulcers

Secondary Outcome Measures :
  1. Different risk factors: age, length, weight, incontinence, urinary catheter, blood pressure, mobility, activity, diabetes, CVA, KATZ score, medication, duration in a sitting posture

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • non-blanchable erythema above a bony prominence
  • Informed consent

Exclusion Criteria:

  • Pressure ulcers grade 3 or 4
  • Turning contra-indicated based on medical grounds
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262444


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Distrac
Investigators
Principal Investigator: Tom Defloor, PhD University Ghent
More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00262444     History of Changes
Other Study ID Numbers: 2003/084
First Posted: December 6, 2005    Key Record Dates
Last Update Posted: December 28, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Pressure Ulcer
Skin Ulcer
Skin Diseases