Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
Primary Purpose
Pressure Ulcer, Pressure Injury, Pressure Sore
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CuroCell S.A.M. ® pro mattress
Sponsored by
About this trial
This is an interventional prevention trial for Pressure Ulcer focused on measuring Static air support surface, Support device, Elderly, Prevention
Eligibility Criteria
Inclusion Criteria:
- At risk of pressure ulcer development based on a Braden score ≤ 17
- 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
- Pressure ulcer Cat. II+ present on initial evaluation
Sites / Locations
- WZC Sint-Vincentius
- WZC Sint-Jozef
- WZC Sint-Vincentius
- WZC Brugse Vaart
- Provinciaal Zorgcentrum Lemberge
- WZC Onderdale
- Residentie Vroonstalle
- WZC Sint-Rafaël
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CuroCell S.A.M. ® pro mattress
Arm Description
Mattresses of eligible participants will be replaced by a static air pressure redistribution mattress (CuroCell S.A.M. ® Pro).
Outcomes
Primary Outcome Measures
Pressure ulcer incidence (Cat. II+), (NPUAP classification system)
Development of at least 1 pressure ulcer Cat. II+ during study period, not associated with the use of medical devices
Secondary Outcome Measures
Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)
Development of at least 1 pressure ulcer Cat. I during study period, not associated with the use of medical devices
Comfort of participants (self developed questionnaire)
A quantitative approach to obtain insight in residents' experiences and perceptions of comfort by using a questionnaire
Full Information
NCT ID
NCT03725787
First Posted
October 25, 2018
Last Updated
May 3, 2021
Sponsor
University Ghent
Collaborators
Care of Sweden
1. Study Identification
Unique Protocol Identification Number
NCT03725787
Brief Title
Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
Official Title
Pressure Ulcer Incidence Cat. II+ on the CuroCell SAM® PRO Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 4, 2018 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
October 6, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Care of Sweden
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.
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 found a pressure ulcer incidence of 5.1% in patients placed on static air support (mattress overlay, heel wedge and seat cushion) in a high risk population in a nursing home setting in Belgium.
The CuroCell SAM PRO (Care of Sweden AB) is a static air mattress overlay system used as prevent and treat pressure ulcers (up to category 3) and for pain therapy. The aim of current study is to measure pressure ulcer incidence on the CuroCell Sam PRO static air mattress in nursing home residents at risk for pressure ulcer development over a 30-day period in Belgium.
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 surface, Support device, Elderly, Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CuroCell S.A.M. ® pro mattress
Arm Type
Experimental
Arm Description
Mattresses of eligible participants will be replaced by a static air pressure redistribution mattress (CuroCell S.A.M. ® Pro).
Intervention Type
Device
Intervention Name(s)
CuroCell S.A.M. ® pro mattress
Intervention Description
During 30 days, participants will use the static air mattress.
Primary Outcome Measure Information:
Title
Pressure ulcer incidence (Cat. II+), (NPUAP classification system)
Description
Development of at least 1 pressure ulcer Cat. II+ during study period, not associated with the use of medical devices
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)
Description
Development of at least 1 pressure ulcer Cat. I during study period, not associated with the use of medical devices
Time Frame
30 days
Title
Comfort of participants (self developed questionnaire)
Description
A quantitative approach to obtain insight in residents' experiences and perceptions of comfort by using a questionnaire
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At risk of pressure ulcer development based on a Braden score ≤ 17
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
Pressure ulcer Cat. II+ present on initial evaluation
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 Sint-Vincentius
City
Deinze
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9800
Country
Belgium
Facility Name
WZC Sint-Jozef
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Facility Name
WZC Sint-Vincentius
City
Kaprijke
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9970
Country
Belgium
Facility Name
WZC Brugse Vaart
City
Mariakerke
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9030
Country
Belgium
Facility Name
Provinciaal Zorgcentrum Lemberge
City
Merelbeke
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9820
Country
Belgium
Facility Name
WZC Onderdale
City
Ursel
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9910
Country
Belgium
Facility Name
Residentie Vroonstalle
City
Wondelgem
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9032
Country
Belgium
Facility Name
WZC Sint-Rafaël
City
Liedekerke
State/Province
Vlaams-Brabant
ZIP/Postal Code
1770
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Western Australia; 201.
Results Reference
background
PubMed Identifier
25625315
Citation
Levy A, Kopplin K; BS; Gefen A. Computer simulations of efficacy of air-cell-based cushions in protecting against reoccurrence of pressure ulcers. J Rehabil Res Dev. 2014;51(8):1297-319. doi: 10.1682/JRRD.2014.02.0048.
Results Reference
background
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
Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
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