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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Vlaams-Brabant
    • Asse, Vlaams-Brabant, Belgium, 1770
      • WZC Hof ter Waarbeek

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 110 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	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.
EXPERIMENTAL: 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort	perceived comfort and experiences of users of the mattress - using self-developed questionnaire	30 days

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Care of Sweden AB
• Investigators: Principal Investigator: Dimitri Beeckman, Phd, Study Principal Investigator

Publications and helpful links

General Publications

• 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.

Helpful Links

• Website of the research group

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 20, 2019
• Primary Completion (ACTUAL): October 12, 2019
• Study Completion (ACTUAL): October 30, 2019

Study Registration Dates

• First Submitted: May 5, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (ACTUAL): May 18, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 17, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Elderly; treatment; prevention; Nursing home; support surface
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Wounds and Injuries; Skin Ulcer; Ulcer; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: EC/2018/1291

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No