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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04890678
• Other study ID #: EC/2018/1291
• Status: Completed
• Phase: N/A
• Start date: February 20, 2019
• Est. completion date: October 30, 2019

Study information

• Verified date: October 2019
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Crush Injuries
• Pressure Injury
• Pressure Sore
• Pressure Ulcer
• Pressure Ulcer, Buttock
• Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	WZC Hof ter Waarbeek	Asse	Vlaams-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Care of Sweden AB

Country where clinical trial is conducted

Belgium, 

References & 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. — View Citation

Outcome

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

External Links

•   Website of the research group