- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00262444
Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
December 19, 2007 updated by: University Ghent
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.
Study Type
Interventional
Enrollment (Actual)
500
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
-
-
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Ghent, Belgium, 9000
- University Hospital Ghent
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of pressure ulcers
Time Frame: during 5 weeks
|
during 5 weeks
|
|
Time to develop pressure ulcers
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Different risk factors: age, length, weight, incontinence, urinary catheter, blood pressure, mobility, activity, diabetes, CVA, KATZ score, medication, duration in a sitting posture
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Tom Defloor, PhD, University Ghent
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
September 1, 2003
Study Completion (Actual)
May 1, 2005
Study Registration Dates
First Submitted
December 4, 2005
First Submitted That Met QC Criteria
December 4, 2005
First Posted (Estimate)
December 6, 2005
Study Record Updates
Last Update Posted (Estimate)
December 28, 2007
Last Update Submitted That Met QC Criteria
December 19, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003/084
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.