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

University Ghent

Status: Completed

Conditions: Pressure Ulcer; Pressure Injury; Pressure Ulcer, Buttock; Pressure Sore

Treatments: Device: 22 residentsat risk for PU development; Device: 18 residents at least one PU category III-IV in the sacral area

Study type: Interventional

Funder types: Other

Identifiers

NCT04890678

EC/2018/1291

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 65 to 110 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

22 residentsat risk for PU development

Experimental group

Description:

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

Treatment:

Device: 22 residentsat risk for PU development

18 residents at least one PU category III-IV in the sacral area

Experimental group

Description:

18 residents at least one PU category III-IV in the sacral area aged 65 years or over

Treatment:

Device: 18 residents at least one PU category III-IV in the sacral area