The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedFirst Submitted
Initial submission to the registry
May 5, 2021
CompletedFirst Posted
Study publicly available on registry
May 18, 2021
CompletedMay 18, 2021
October 1, 2019
8 months
May 5, 2021
May 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Comfort
30 days
Study Arms (2)
22 residentsat risk for PU development
EXPERIMENTAL22 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
18 residents at least one PU category III-IV in the sacral area
EXPERIMENTAL18 residents at least one PU category III-IV in the sacral area aged 65 years or over
Interventions
mattress in bed The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning.
mattress in bed The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning. In the group of participants with a PU category III or IV, the Pressure Ulcer Scale for Healing Tool (PUSH) will be used to assess and measure change in PU status. The score on the PUSH-tool is defined by the surface area of the PU (length x width), the amount of exudate and the type of tissue in the wound bed.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Short-stay residents (expected length of stay ≤14 days)
- End of life care
- Medical contraindication for patient repositioning/turning
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
- Care of Sweden ABcollaborator
Study Sites (1)
WZC Hof ter Waarbeek
Asse, Vlaams-Brabant, 1770, Belgium
Related Publications (1)
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. doi: 10.1186/s13063-016-1703-8.
PMID: 27993145BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dimitri Beeckman, Phd
Study Principal Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2021
First Posted
May 18, 2021
Study Start
February 20, 2019
Primary Completion
October 12, 2019
Study Completion
October 30, 2019
Last Updated
May 18, 2021
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share