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

Not Applicable

Completed

• Conditions: Pressure Ulcer, Buttock; Pressure Ulcer; Pressure Injury; Pressure Sore
• Interventions: Device: 18 residents at least one PU category III-IV in the sacral area; Device: 22 residentsat risk for PU development

• Registration Number: NCT04890678
• Lead Sponsor: University Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-20
• Status Verified: 2019-10
• Primary Completion: 2019-10-12
• Study Completion: 2019-10-30
• Study First Submitted: 2021-05-05
• Study First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Study First Posted: 2021-05-18
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
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	18 residents at least one PU category III-IV in the sacral area aged 65 years or over
22 residentsat risk for PU development	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

Primary Outcome Measures

Name	Time	Method
Pressure ulcer incidence	30 days	Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system
Pressure ulcer healing	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)

Secondary Outcome Measures

Name	Time	Method
Comfort	30 days	perceived comfort and experiences of users of the mattress - using self-developed questionnaire

Trial Locations

Locations (1)

WZC Hof ter Waarbeek; 🇧🇪 Asse, Vlaams-Brabant, Belgium