Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning
NCT ID: NCT02690753
Last Updated: 2018-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
227 participants
INTERVENTIONAL
2016-02-29
2017-12-31
Brief Summary
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The primary aim of this study is to compare the effectiveness of the turn and position system (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve reposition frequence in patients at risk. The second aim is to compare the effectiveness of a tailored protocol versus standard care to improve reposition frequence in patients at risk. The third aim is to compare the effectiveness of standardized incontinence care versus standard care to improve the incidence of pressure ulcers and incontinence-associated dermatitis (IAD). Also a health economic evaluation will be performed.
The study will be performed in hospital setting (university and general hospitals) in a random sample of 226 patients aged \> 18 who are at risk of developing pressure ulcers. Patients will be recruited from three types of wards: intensive care units, geriatric wards and rehabilitation wards. Patients will be included in the study for a period of 8 days.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Tailored repositioning + Standardised incontinence care + TAP
A protocol tailored to individual risk factors will be applied to patients at risk.Comfort Shield® barrier cream cloths will be used for incontinence care every morning and after each episode of incontinence. The Prevalon® Turn and Position System 2.0, SAGE will be used for turning and positioning patients at risk when laying in bed.
A protocol tailored to individual risk factors
The Prevalon® Turn and Position System 2.0
Comfort Shield® barrier cream cloths
Standard repositioning + Standardised incontinence care + TAP
Instead of developing and using a tailored pressure ulcer prevention protocol, patients will receive standard care.Comfort Shield® barrier cream cloths will be used for incontinence care every morning and after each episode of incontinence. The Prevalon® Turn and Position System 2.0, SAGE will be used for turning and positioning patients at risk when laying in bed.
The Prevalon® Turn and Position System 2.0
Comfort Shield® barrier cream cloths
Usual care
Instead of developing and using a tailored pressure ulcer prevention protocol, patients will receive standard care. Instead of using comfort Shield® barrier cream cloths, incontinence care will be given to patients using the standard procedure on the ward. Instead of using the turn and position system, patients will be turned according to the standard procedure on the ward.
No interventions assigned to this group
Interventions
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A protocol tailored to individual risk factors
The Prevalon® Turn and Position System 2.0
Comfort Shield® barrier cream cloths
Eligibility Criteria
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Inclusion Criteria
* Maximum 24hours admitted on the ward at the time of inclusion
* Expected lenght of stay: 8 days
* Free of pressure ulcers category II, II, IV and incontinence-associated dermatitis (IAD) category 2 at the start of the study
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Sage Products, LLC
INDUSTRY
University Ghent
OTHER
Responsible Party
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UCVV
University Centre for Nursing and Midwifery
Principal Investigators
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Dimitri Beeckman, PhD
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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AZ St. Maarten
Duffel, Antwerpen, Belgium
AZ St. Dimpna
Geel, Antwerpen, Belgium
AZ Nikolaas campus Beveren
Beveren, Oost-Vlaanderen, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
AZ Oudenaarde
Oudenaarde, Oost-Vlaanderen, Belgium
ASZ Aalst
Aalst, , Belgium
AZ Monica
Antwerp, , Belgium
ZNA Hoge Beuken
Antwerp, , Belgium
ZNA St. Elisabeth
Antwerp, , Belgium
Imelda Ziekenhuis
Bonheiden, , Belgium
AZ St. Jan Brugge
Bruges, , Belgium
ASZ Geraardsbergen
Geraardsbergen, , Belgium
AZ Delta Menen
Menen, , Belgium
AZ St. Jan Oostende
Ostend, , Belgium
AZ Delta Roeselare
Roeselare, , Belgium
Countries
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References
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Beeckman D, Van Damme N, Schoonhoven L, Van Lancker A, Kottner J, Beele H, Gray M, Woodward S, Fader M, Van den Bussche K, Van Hecke A, De Meyer D, Verhaeghe S. Interventions for preventing and treating incontinence-associated dermatitis in adults. Cochrane Database Syst Rev. 2016 Nov 10;11(11):CD011627. doi: 10.1002/14651858.CD011627.pub2.
Beeckman D, Van Lancker A, Van Hecke A, Verhaeghe S. A systematic review and meta-analysis of incontinence-associated dermatitis, incontinence, and moisture as risk factors for pressure ulcer development. Res Nurs Health. 2014 Jun;37(3):204-18. doi: 10.1002/nur.21593. Epub 2014 Apr 3.
De Meyer D, Van Hecke A, Verhaeghe S, Beeckman D. PROTECT - Trial: A cluster RCT to study the effectiveness of a repositioning aid and tailored repositioning to increase repositioning compliance. J Adv Nurs. 2019 May;75(5):1085-1098. doi: 10.1111/jan.13932. Epub 2019 Jan 25.
Related Links
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Website of the research group
Other Identifiers
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PA2015/041
Identifier Type: -
Identifier Source: org_study_id
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