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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
University Ghent
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer Lesions (Grade 2 or More)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 4, 2005
Last Updated
December 19, 2007
Sponsor
University Ghent
Collaborators
Distrac
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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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