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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Ghent
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Pressure ulcer healing
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 110 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
22 residentsat risk for PU development
22 residents at risk for PU development, defined by a Braden score < 12 and/or a Braden subscale 'Mobility' score ≤ 2 and/or the presence of non-blanchable erythema in the sacral area.
aged 65 years or over
Intervention: 22 residentsat risk for PU development (Device)
18 residents at least one PU category III-IV in the sacral area
18 residents at least one PU category III-IV in the sacral area aged 65 years or over
Intervention: 18 residents at least one PU category III-IV in the sacral area (Device)
Outcomes
Primary Outcomes
Pressure ulcer healing
Time Frame: 30 days
Healing of pressure ulcers category III and IV during the 30-day study period - using the Pressure Ulcer Scale for Healing Tool (PUSH)
Pressure ulcer incidence
Time Frame: 30 days
Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system
Secondary Outcomes
- Comfort(30 days)