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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02690753
Other study ID # PA2015/041
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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