Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
2 other identifiers
interventional
180
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 4, 2018
CompletedFirst Submitted
Initial submission to the registry
October 25, 2018
CompletedFirst Posted
Study publicly available on registry
October 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2020
CompletedMay 6, 2021
October 1, 2018
11 months
October 25, 2018
May 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
30 days
Secondary Outcomes (2)
Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)
30 days
Comfort of participants (self developed questionnaire)
30 days
Study Arms (1)
CuroCell S.A.M. ® pro mattress
EXPERIMENTALMattresses of eligible participants will be replaced by a static air pressure redistribution mattress (CuroCell S.A.M. ® Pro).
Interventions
During 30 days, participants will use the static air mattress.
Eligibility Criteria
You may qualify if:
- At risk of pressure ulcer development based on a Braden score ≤ 17
- Bedbound or chair bound
- Aged ≥ 65
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
- Care of Swedencollaborator
Study Sites (8)
WZC Sint-Vincentius
Deinze, Oost-Vlaanderen, 9800, Belgium
WZC Sint-Jozef
Ghent, Oost-Vlaanderen, 9000, Belgium
WZC Sint-Vincentius
Kaprijke, Oost-Vlaanderen, 9970, Belgium
WZC Brugse Vaart
Mariakerke, Oost-Vlaanderen, 9030, Belgium
Provinciaal Zorgcentrum Lemberge
Merelbeke, Oost-Vlaanderen, 9820, Belgium
WZC Onderdale
Ursel, Oost-Vlaanderen, 9910, Belgium
Residentie Vroonstalle
Wondelgem, Oost-Vlaanderen, 9032, Belgium
WZC Sint-Rafaël
Liedekerke, Vlaams-Brabant, 1770, Belgium
Related Publications (3)
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.
BACKGROUNDLevy 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.
PMID: 25625315BACKGROUNDBrown 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.
PMID: 27993145BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dimitri Beeckman, Phd
Study Principal Investigator
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2018
First Posted
October 31, 2018
Study Start
March 4, 2018
Primary Completion
February 6, 2019
Study Completion
October 6, 2020
Last Updated
May 6, 2021
Record last verified: 2018-10