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| ID | Type | Description | Link |
|---|---|---|---|
| B670201835095 | Other Identifier | Ethics Committee UZ Gent |
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| Name | Class |
|---|---|
| Care of Sweden | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CuroCell S.A.M. Ā® pro mattress | Experimental | Mattresses of eligible participants will be replaced by a static air pressure redistribution mattress (CuroCell S.A.M. Ā® Pro). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CuroCell S.A.M. Ā® pro mattress | Device | During 30 days, participants will use the static air mattress. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Comfort of participants (self developed questionnaire) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dimitri Beeckman, Phd | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WZC Sint-Vincentius | Deinze | Oost-Vlaanderen | 9800 | Belgium | ||
| WZC Sint-Jozef |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 25625315 | Background | 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. | |
| 27993145 |
| Label | URL |
|---|---|
| Website of the research group | View source |
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A quantitative approach to obtain insight in residents' experiences and perceptions of comfort by using a questionnaire |
| 30 days |
| 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-Rafaƫl | Liedekerke | Vlaams-Brabant | 1770 | Belgium |
| Background |
| 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. |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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