Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning

Not Applicable

Completed

• Conditions: Pressure Ulcers; Incontinence-associated Dermatitis

• 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

Study Timeline

• Study First Submitted: 2015-12-08
• Study Start: 2016-02
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

Inclusion Criteria

• 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

Exclusion Criteria

• Patients with no active or supportive therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 St. Maarten; 🇧🇪 Duffel, Antwerpen, Belgium

AZ St. Dimpna; 🇧🇪 Geel, Antwerpen, Belgium

AZ Nikolaas campus Beveren; 🇧🇪 Beveren, Oost-Vlaanderen, Belgium

UZ Gent; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

AZ Oudenaarde; 🇧🇪 Oudenaarde, Oost-Vlaanderen, Belgium

ASZ Aalst; 🇧🇪 Aalst, Belgium

AZ Monica; 🇧🇪 Antwerpen, Belgium

ZNA Hoge Beuken; 🇧🇪 Antwerpen, Belgium

ZNA St. Elisabeth; 🇧🇪 Antwerpen, Belgium

Imelda Ziekenhuis; 🇧🇪 Bonheiden, Belgium

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