NCT04890678

The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 65 Years – 110 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pressure Ulcer
• Pressure Injury
• Pressure Sore
• Pressure Ulcer, Buttock

Interventions

Type	Name	Description
DEVICE	22 residentsat risk for PU development	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.
DEVICE	18 residents at least one PU category III-IV in the sacral area	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.

Timeline

• Start date: 2019-02-20
• Primary completion: 2019-10-12
• Completion: 2019-10-30
• First posted: 2021-05-18
• Last updated: 2021-05-18

Locations

1 site across 1 country: Belgium