Pressure Ulcer Clinical Trial
Official title:
The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment: a Clinical Test in 10 Belgian Nursing Homes
Verified date | October 2019 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.
Status | Completed |
Enrollment | 40 |
Est. completion date | October 30, 2019 |
Est. primary completion date | October 12, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 110 Years |
Eligibility | Inclusion Criteria: - At risk of pressure ulcer development based on a Braden score = 17 or pressure ulcer category III or IV - Bedbound or chair bound - Aged = 65 Exclusion Criteria: - Short-stay residents (expected length of stay =14 days) - End of life care - Medical contraindication for patient repositioning/turning |
Country | Name | City | State |
---|---|---|---|
Belgium | WZC Hof ter Waarbeek | Asse | Vlaams-Brabant |
Lead Sponsor | Collaborator |
---|---|
University Ghent | Care of Sweden AB |
Belgium,
Brown S, Smith IL, Brown JM, Hulme C, McGinnis E, Stubbs N, Nelson EA, Muir D, Rutherford C, Walker K, Henderson V, Wilson L, Gilberts R, Collier H, Fernandez C, Hartley S, Bhogal M, Coleman S, Nixon JE. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial. Trials. 2016 Dec 20;17(1):604. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pressure ulcer incidence | Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system | 30 days | |
Primary | Pressure ulcer healing | Healing of pressure ulcers category III and IV during the 30-day study period - using the Pressure Ulcer Scale for Healing Tool (PUSH) | 30 days | |
Secondary | Comfort | perceived comfort and experiences of users of the mattress - using self-developed questionnaire | 30 days |
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