Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
Primary Purpose
Pressure Ulcer Lesions (Grade 2 or More)
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Different turning frequencies
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcer Lesions (Grade 2 or More)
Eligibility 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
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
Incidence of pressure ulcers
Time to develop pressure ulcers
Secondary Outcome Measures
Different risk factors: age, length, weight, incontinence, urinary catheter, blood pressure, mobility, activity, diabetes, CVA, KATZ score, medication, duration in a sitting posture
Full Information
NCT ID
NCT00262444
First Posted
December 4, 2005
Last Updated
December 19, 2007
Sponsor
University Ghent
Collaborators
Distrac
1. Study Identification
Unique Protocol Identification Number
NCT00262444
Brief Title
Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
Official Title
Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Ghent
Collaborators
Distrac
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.
Detailed Description
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer Lesions (Grade 2 or More)
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Different turning frequencies
Primary Outcome Measure Information:
Title
Incidence of pressure ulcers
Time Frame
during 5 weeks
Title
Time to develop pressure ulcers
Secondary Outcome Measure Information:
Title
Different risk factors: age, length, weight, incontinence, urinary catheter, blood pressure, mobility, activity, diabetes, CVA, KATZ score, medication, duration in a sitting posture
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Defloor, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
17184374
Citation
Vanderwee K, Grypdonck MH, De Bacquer D, Defloor T. Effectiveness of turning with unequal time intervals on the incidence of pressure ulcer lesions. J Adv Nurs. 2007 Jan;57(1):59-68. doi: 10.1111/j.1365-2648.2006.04060.x.
Results Reference
result
Links:
URL
http://www.ugent.be
Description
Website of the University Ghent
Learn more about this trial
Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
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