Clinical trial NCT02690753: Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcers
Incontinence-associated Dermatitis
Keywords: Repositioning
Incontinence care
Prevention
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Sage Products, LLC
First posted: 2016-02-24
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Turning compliance of nurses within the trial period as assessed by the researcher (unannounced)
timeFrame: within 8 days after the start of the study
Secondary outcomes:
measure: Turning angle
timeFrame: within 8 days after the start of the study
measure: Sacrum free of pressure
timeFrame: within 8 days after the start of the study
measure: Incidence of pressure ulcers and incontinence-associated dermatitis
timeFrame: within 8 days after the start of the study
measure: Comfort and preferences of the caregiver
timeFrame: On baseline and at day 8 (the end of the study)
measure: Comfort and tolerance of the patient
timeFrame: At day 8 (the end of the study)
measure: Cost-effectiveness of the prevention of pressure ulcers
timeFrame: For the duration of the study (8 days)
Other outcomes:
Locations:
city: Duffel
country: Belgium
facility: AZ St. Maarten
state: Antwerpen
city: Geel
country: Belgium
facility: AZ St. Dimpna
state: Antwerpen
city: Beveren
country: Belgium
facility: AZ Nikolaas campus Beveren
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-Vlaanderen
city: Oudenaarde
country: Belgium
facility: AZ Oudenaarde
state: Oost-Vlaanderen
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Antwerpen
country: Belgium
facility: AZ Monica
city: Antwerpen
country: Belgium
facility: ZNA Hoge Beuken
city: Antwerpen
country: Belgium
facility: ZNA St. Elisabeth
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Brugge
country: Belgium
facility: AZ St. Jan Brugge
city: Geraardsbergen
country: Belgium
facility: ASZ Geraardsbergen
city: Menen
country: Belgium
facility: AZ Delta Menen
city: Oostende
country: Belgium
facility: AZ St. Jan Oostende
city: Roeselare
country: Belgium
facility: AZ Delta Roeselare
Study officials:
affiliation: University Ghent
name: Dimitri Beeckman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.