- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03725787
Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
Pressure Ulcer Incidence Cat. II+ on the CuroCell SAM® PRO Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Oost-Vlaanderen
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Deinze, Oost-Vlaanderen, Belgium, 9800
- WZC Sint-Vincentius
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Gent, Oost-Vlaanderen, Belgium, 9000
- WZC Sint-Jozef
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Kaprijke, Oost-Vlaanderen, Belgium, 9970
- WZC Sint-Vincentius
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Mariakerke, Oost-Vlaanderen, Belgium, 9030
- WZC Brugse Vaart
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Merelbeke, Oost-Vlaanderen, Belgium, 9820
- Provinciaal Zorgcentrum Lemberge
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Ursel, Oost-Vlaanderen, Belgium, 9910
- WZC Onderdale
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Wondelgem, Oost-Vlaanderen, Belgium, 9032
- Residentie Vroonstalle
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Vlaams-Brabant
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Liedekerke, Vlaams-Brabant, Belgium, 1770
- WZC Sint-Rafaël
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CuroCell S.A.M. ® pro mattress
Mattresses of eligible participants will be replaced by a static air pressure redistribution mattress (CuroCell S.A.M. ® Pro).
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During 30 days, participants will use the static air mattress.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure ulcer incidence (Cat. II+), (NPUAP classification system)
Time Frame: 30 days
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Development of at least 1 pressure ulcer Cat.
II+ during study period, not associated with the use of medical devices
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30 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)
Time Frame: 30 days
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Development of at least 1 pressure ulcer Cat.
I during study period, not associated with the use of medical devices
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30 days
|
Comfort of participants (self developed questionnaire)
Time Frame: 30 days
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A quantitative approach to obtain insight in residents' experiences and perceptions of comfort by using a questionnaire
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30 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dimitri Beeckman, Phd, Study Principal Investigator
Publications and helpful links
General Publications
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC/2018/0091
- B670201835095 (OTHER: Ethics Committee UZ Gent)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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