Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning
A Turn and Positioning System and Standardized Incontinence Care Combined With Tailored Repositioning Versus a Standard Repositioning Protocol for Pressure Ulcer Prevention: A Multicenter Prospective Randomized Controlled Clinical Trial and Health Economical Analysis in a Hospital Setting
1 other identifier
interventional
227
1 country
15
Brief Summary
The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors are pressure or pressure combined with shear. Prevention is very important and comprises: preventive skin care including cleansing and protecting the skin from exposure to moisture, the systematic repositioning of the patient, the offloading of the heels from the surface of the bed, the use of adequate bed support surfaces and an adequate nutritional status. The development and implementation of a risk based prevention plan for individuals identified as being at risk is strongly recommended. Limited compliance exists towards pressure ulcer preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of rigorously performed research addressing the effectiveness of devices or risk based protocols to improve compliance. Health care budgets are limited, priorities should be set in the allocation of health care resources. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
Typical duration for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedFirst Posted
Study publicly available on registry
February 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 9, 2018
March 1, 2018
1.8 years
December 8, 2015
March 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Turning compliance of nurses within the trial period as assessed by the researcher (unannounced)
The researcher wil collect and administer data about turning compliance and compliance with the protocol
within 8 days after the start of the study
Secondary Outcomes (6)
Turning angle
within 8 days after the start of the study
Sacrum free of pressure
within 8 days after the start of the study
Incidence of pressure ulcers and incontinence-associated dermatitis
within 8 days after the start of the study
Comfort and preferences of the caregiver
On baseline and at day 8 (the end of the study)
Comfort and tolerance of the patient
At day 8 (the end of the study)
- +1 more secondary outcomes
Study Arms (3)
Tailored repositioning + Standardised incontinence care + TAP
EXPERIMENTALA 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.
Standard repositioning + Standardised incontinence care + TAP
EXPERIMENTALInstead 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.
Usual care
NO INTERVENTIONInstead 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.
Interventions
Eligibility Criteria
You may qualify if:
- At risk of developing pressure ulcers (Braden score \< 17)
- 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
You may not qualify if:
- \- Patients with no active or supportive therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Ghentlead
- Sage Products, LLCcollaborator
Study Sites (15)
AZ St. Maarten
Duffel, Antwerpen, 2570, 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, 9700, 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
Related Publications (3)
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.
PMID: 27841440BACKGROUNDBeeckman 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.
PMID: 24700170BACKGROUNDDe 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.
PMID: 30549321DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dimitri Beeckman, PhD
University Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- University Centre for Nursing and Midwifery
Study Record Dates
First Submitted
December 8, 2015
First Posted
February 24, 2016
Study Start
February 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
March 9, 2018
Record last verified: 2018-03