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
Verified date | March 2018 |
Source | University Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Ghent | Sage Products, LLC |
Belgium,
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
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 |
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