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

Pressure Ulcers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690753
• Other study ID #: PA2015/041
• Status: Completed
• Phase: N/A
• First received: December 8, 2015
• Last updated: March 8, 2018
• Start date: February 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2018
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Incontinence-associated Dermatitis
• Pressure Ulcer
• Pressure Ulcers
• Ulcer

Intervention

Procedure:
• A protocol tailored to individual risk factors

Device:
• The Prevalon® Turn and Position System 2.0

• Comfort Shield® barrier cream cloths

Locations

Country	Name	City	State
Belgium	ASZ Aalst	Aalst
Belgium	AZ Monica	Antwerpen
Belgium	ZNA Hoge Beuken	Antwerpen
Belgium	ZNA St. Elisabeth	Antwerpen
Belgium	AZ Nikolaas campus Beveren	Beveren	Oost-Vlaanderen
Belgium	Imelda Ziekenhuis	Bonheiden
Belgium	AZ St. Jan Brugge	Brugge
Belgium	AZ St. Maarten	Duffel	Antwerpen
Belgium	AZ St. Dimpna	Geel	Antwerpen
Belgium	UZ Gent	Gent	Oost-Vlaanderen
Belgium	ASZ Geraardsbergen	Geraardsbergen
Belgium	AZ Delta Menen	Menen
Belgium	AZ St. Jan Oostende	Oostende
Belgium	AZ Oudenaarde	Oudenaarde	Oost-Vlaanderen
Belgium	AZ Delta Roeselare	Roeselare

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Sage Products, LLC

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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:CD011627. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Turning angle	Per patient the researcher will measure two times the turning angle in which the patient is positioned.	within 8 days after the start of the study
Secondary	Sacrum free of pressure	Per patient the researcher will investigate two times if the sacrum is free of pressure while the patient is positioned.	within 8 days after the start of the study
Secondary	Incidence of pressure ulcers and incontinence-associated dermatitis		within 8 days after the start of the study
Secondary	Comfort and preferences of the caregiver	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.	On baseline and at day 8 (the end of the study)
Secondary	Comfort and tolerance of the patient	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.	At day 8 (the end of the study)
Secondary	Cost-effectiveness of the prevention of pressure ulcers	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	For the duration of the study (8 days)

External Links

•   Website of the research group