What is the Incidence of Pressure Ulcer Category II-IV (Including Deep-tissue Injury and Unstageable) on a Static Air Foam Hybrid Mattress?
Primary Purpose
Pressure Ulcer, Pressure Injury, Pressure Sore
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Ultracore Repose® mattress
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcer focused on measuring static air support devices, High risk population, Elderly, Prevention, Pressure Ulcer
Eligibility Criteria
Nursing home residents:
Inclusion criteria:
- High risk of pressure ulcers (Braden score < 12) and/or pressure ulcer category 1,
- Bedbound (> 8 hours in bed) or chair bound (> 8 hours in chair),
- Aged > 65 years,
Exclusion criteria:
- Pressure ulcer Category II-IV, deep tissue injury (DTI) or unstageable pressure ulcer,
- Expected length of stay < 2 weeks,
- End of life care,
- Medical contraindication for use of static air support devices
Caretakers:
Caretakers will be included in the focus group interviews if they have experience with the use of both the Ultracore Repose® mattress and the Repose overlay mattress®
Sites / Locations
- WZC Egmont
- WZC Heilig Hart
- Woonzorgcentrum Ter Potterie
- Huize Zonnelied
- De Plataan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: Static air support devices (Ultracore Repose®)
Arm Description
Residents will be placed on a static air foam hybrid mattress during 14 days: • Ultracore Repose® Mattress
Outcomes
Primary Outcome Measures
Pressure ulcer incidence (Cat. II+)
Incidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices
Secondary Outcome Measures
Insight in caretakers' experiences and perceptions
Insight in caretakers' experiences and perceptions (outcome of the focus group interviews) after using Static Air Foam Hybrid Mattress
Full Information
NCT ID
NCT05142878
First Posted
November 19, 2021
Last Updated
December 7, 2021
Sponsor
University Ghent
Collaborators
Frontier Medical Group, UK
1. Study Identification
Unique Protocol Identification Number
NCT05142878
Brief Title
What is the Incidence of Pressure Ulcer Category II-IV (Including Deep-tissue Injury and Unstageable) on a Static Air Foam Hybrid Mattress?
Official Title
Pressure Ulcer Prevention Using Static Air Foam Hybrid Mattress (Ultracore Repose®) in a High Risk Population in Nursing Homes: A Multi-Center Cohort and Qualitative Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 15, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Frontier Medical Group, UK
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. They occur frequently among patients with limited mobility, such as those patients being bed-bound and/or wheelchair-bound. In many countries, pressure ulcers are recognized as a national health issue and governments designate pressure ulcers as one of the most important sentinel events for healthcare.
International guidelines recommend the use of pressure redistributing support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. All interventions should be patient-tailored and based on a thorough assessment of both the patient and contextual risk factors. As pressure ulcers can arise in a number of ways, interventions for prevention and treatment need to be applied across a wide range of settings, including the community, nursing homes and hospitals.
A review of mortality and severe harm incidents reported to the National Reporting and Learning System found that pressure ulcers were the largest proportion of patient safety incidents in 2011/2012, accounting for 19% of all reports.
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 analysing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.
Continuous low levels or short-term high levels of pressure and shear on the skin and underlying tissue on vulnerable areas are extrinsic factors contributing to the development of pressure ulcers. Support surfaces (e.g. any mattresses, integrated bed systems, mattress replacement, overlay, seat cushion, or seat cushion overlay) are specialized devices for pressure redistribution specifically designed for management of tissue loads, micro- climate, and/or therapeutic functions.
A Cochrane systematic review by McInnes et al. (2015) defined multiple groups of pressure redistribution materials: low-tech (not electrically driven) constant low-pressure supports, high-tech supported surfaces, and other supported surfaces (operating table mattress pad, rotating beds, cushions, and limb protectors). Static or reactive overlay mattresses are an example of a low-tech constant low pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman (2016) found a pressure ulcer incidence of 5.1% in patients placed on static air support surfaces (mattress overlay, heel wedge, and seat cushion) in a high risk population in a nursing home setting in Belgium.
A multicentre randomised controlled clinical trial in 26 nursing homes (including 308 residents) between April 2017 and May 2018 resulted in a significantly lower pressure ulcer incidence when applying the principle of static air (n=8/154, 5.2%) compared to the alternating air group (n=18/154, 11.7%)(p=0.04). The median time to develop a pressure ulcer category II-IV was significantly longer in the static air group (10.5 days, IQR 1-14) compared to the alternating air group (5.4 days, IQR 1-12; p=0.05). The study concluded that a static air mattress was significantly more effective compared to an alternating air pressure mattress to prevent pressure ulcers in a high risk nursing home population.
This multicentre cohort study will be performed in 5 nursing homes in a random sample of 40 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher.
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, Bed Sore
Keywords
static air support devices, High risk population, Elderly, Prevention, Pressure Ulcer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Static air support devices (Ultracore Repose®)
Arm Type
Experimental
Arm Description
Residents will be placed on a static air foam hybrid mattress during 14 days:
• Ultracore Repose® Mattress
Intervention Type
Device
Intervention Name(s)
Ultracore Repose® mattress
Intervention Description
Residents will be placed on the Ultracore Repose® mattress during 14 days
Primary Outcome Measure Information:
Title
Pressure ulcer incidence (Cat. II+)
Description
Incidence rate of pressure ulcers Cat. II-IV (including deep- tissue injury, unstageable), not associated with the use of medical devices
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Insight in caretakers' experiences and perceptions
Description
Insight in caretakers' experiences and perceptions (outcome of the focus group interviews) after using Static Air Foam Hybrid Mattress
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Nursing home residents:
Inclusion criteria:
High risk of pressure ulcers (Braden score < 12) and/or pressure ulcer category 1,
Bedbound (> 8 hours in bed) or chair bound (> 8 hours in chair),
Aged > 65 years,
Exclusion criteria:
Pressure ulcer Category II-IV, deep tissue injury (DTI) or unstageable pressure ulcer,
Expected length of stay < 2 weeks,
End of life care,
Medical contraindication for use of static air support devices
Caretakers:
Caretakers will be included in the focus group interviews if they have experience with the use of both the Ultracore Repose® mattress and the Repose overlay mattress®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Beeckman
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
WZC Egmont
City
Zottegem
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
WZC Heilig Hart
City
Oudenaarde
State/Province
Osst-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Ter Potterie
City
Brugge
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Huize Zonnelied
City
Ieper
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
De Plataan
City
Izegem
State/Province
West-Vlaanderen
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.ucvvgent.be
Description
Description Website of the research group
Learn more about this trial
What is the Incidence of Pressure Ulcer Category II-IV (Including Deep-tissue Injury and Unstageable) on a Static Air Foam Hybrid Mattress?
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