Pressure Ulcer Lesions (Grade 2 or More) Clinical Trial
Official title:
Effectivity and Efficiency of Turning Frequencies: a Randomised Controlled Trial
| Verified date | December 2007 |
| Source | University Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Interventional |
Evaluation of the difference in pressure ulcer incidence or the time to develop pressure ulcers depending on the turning frequencies.
| Status | Completed |
| Enrollment | 500 |
| Est. completion date | May 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Ghent | Distrac |
Belgium,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of pressure ulcers | during 5 weeks | ||
| Primary | Time to develop pressure ulcers | |||
| Secondary | Different risk factors: age, length, weight, incontinence, urinary catheter, blood pressure, mobility, activity, diabetes, CVA, KATZ score, medication, duration in a sitting posture |