The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment
Primary Purpose
Pressure Ulcer, Pressure Injury, Pressure Sore
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
22 residentsat risk for PU development
18 residents at least one PU category III-IV in the sacral area
Sponsored by
About this trial
This is an interventional supportive care trial for Pressure Ulcer focused on measuring support surface, Elderly, Nursing home, prevention, treatment
Eligibility Criteria
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
Sites / Locations
- WZC Hof ter Waarbeek
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
22 residentsat risk for PU development
18 residents at least one PU category III-IV in the sacral area
Arm 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
18 residents at least one PU category III-IV in the sacral area aged 65 years or over
Outcomes
Primary Outcome Measures
Pressure ulcer incidence
Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system
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)
Secondary Outcome Measures
Comfort
perceived comfort and experiences of users of the mattress - using self-developed questionnaire
Full Information
NCT ID
NCT04890678
First Posted
May 5, 2021
Last Updated
May 17, 2021
Sponsor
University Ghent
Collaborators
Care of Sweden AB
1. Study Identification
Unique Protocol Identification Number
NCT04890678
Brief Title
The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 20, 2019 (Actual)
Primary Completion Date
October 12, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Care of Sweden AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Pressure Injury, Pressure Sore, Pressure Ulcer, Buttock
Keywords
support surface, Elderly, Nursing home, prevention, treatment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
22 residentsat risk for PU development
Arm Type
Experimental
Arm 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
Arm Title
18 residents at least one PU category III-IV in the sacral area
Arm Type
Experimental
Arm Description
18 residents at least one PU category III-IV in the sacral area aged 65 years or over
Intervention Type
Device
Intervention Name(s)
22 residentsat risk for PU development
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
18 residents at least one PU category III-IV in the sacral area
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pressure ulcer incidence
Description
Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system
Time Frame
30 days
Title
Pressure ulcer healing
Description
Healing of pressure ulcers category III and IV during the 30-day study period - using the Pressure Ulcer Scale for Healing Tool (PUSH)
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Comfort
Description
perceived comfort and experiences of users of the mattress - using self-developed questionnaire
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Beeckman, Phd
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
WZC Hof ter Waarbeek
City
Asse
State/Province
Vlaams-Brabant
ZIP/Postal Code
1770
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27993145
Citation
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.
Results Reference
background
Links:
URL
https://www.skintghent.be/en
Description
Website of the research group
Learn more about this trial
The Use of a Fully Automated Pulsating Support System (CuroCell® A4 CX20) in Pressure Ulcer Prevention and Treatment
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