Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning
- Conditions
- Pressure UlcersIncontinence-associated Dermatitis
- Interventions
- Device: The Prevalon® Turn and Position System 2.0Procedure: A protocol tailored to individual risk factorsDevice: Comfort Shield® barrier cream cloths
- Registration Number
- NCT02690753
- Lead Sponsor
- University Ghent
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 227
- At risk of developing pressure ulcers (Braden score < 17)
- 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
- Patients with no active or supportive therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard repositioning + Standardised incontinence care + TAP The Prevalon® Turn and Position System 2.0 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. Tailored repositioning + Standardised incontinence care + TAP A protocol tailored to individual risk factors 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. Tailored repositioning + Standardised incontinence care + TAP The Prevalon® Turn and Position System 2.0 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. Standard repositioning + Standardised incontinence care + TAP Comfort Shield® barrier cream cloths 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. Tailored repositioning + Standardised incontinence care + TAP Comfort Shield® barrier cream cloths 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.
- Primary Outcome Measures
Name Time Method Turning compliance of nurses within the trial period as assessed by the researcher (unannounced) within 8 days after the start of the study The researcher wil collect and administer data about turning compliance and compliance with the protocol
- Secondary Outcome Measures
Name Time Method Turning angle within 8 days after the start of the study Per patient the researcher will measure two times the turning angle in which the patient is positioned.
Sacrum free of pressure within 8 days after the start of the study Per patient the researcher will investigate two times if the sacrum is free of pressure while the patient is positioned.
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) Questions on comfort and preferences of the TAP, comfort shield barrier cream cloths and tailored repositioning will be assessed. At baseline these questions will assess the traditional care.
Comfort and tolerance of the patient At day 8 (the end of the study) Questions on comfort and tolerance of the TAP, comfort shield barrier cream cloths and repositioning will be assessed by the caregiver. At baseline these questions will assess the traditional care.
Cost-effectiveness of the prevention of pressure ulcers For the duration of the study (8 days) The following costs will be calculated to provide insight concerning cost-effectiveness:
Objective time analysis of repositioning (by using a chronometer), Subjective time analysis of repositioning, Daily consumption of comfort shield barrier cream cloths and microclimate body pads
Trial Locations
- Locations (15)
AZ Oudenaarde
🇧🇪Oudenaarde, Oost-Vlaanderen, Belgium
ZNA St. Elisabeth
🇧🇪Antwerpen, Belgium
Imelda Ziekenhuis
🇧🇪Bonheiden, Belgium
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
AZ St. Maarten
🇧🇪Duffel, Antwerpen, Belgium
AZ St. Dimpna
🇧🇪Geel, Antwerpen, Belgium
ASZ Aalst
🇧🇪Aalst, Belgium
AZ St. Jan Oostende
🇧🇪Oostende, Belgium
AZ Delta Roeselare
🇧🇪Roeselare, Belgium
AZ Nikolaas campus Beveren
🇧🇪Beveren, Oost-Vlaanderen, Belgium
AZ Monica
🇧🇪Antwerpen, Belgium
ZNA Hoge Beuken
🇧🇪Antwerpen, Belgium
AZ St. Jan Brugge
🇧🇪Brugge, Belgium
ASZ Geraardsbergen
🇧🇪Geraardsbergen, Belgium
AZ Delta Menen
🇧🇪Menen, Belgium