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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04890678
Other study ID # EC/2018/1291
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2019
Est. completion date October 30, 2019

Study information

Verified date October 2019
Source University Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 30, 2019
Est. primary completion date October 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 110 Years
Eligibility Inclusion Criteria: - At risk of pressure ulcer development based on a Braden score = 17 or pressure ulcer category III or IV - Bedbound or chair bound - Aged = 65 Exclusion Criteria: - Short-stay residents (expected length of stay =14 days) - End of life care - Medical contraindication for patient repositioning/turning

Study Design


Intervention

Device:
22 residentsat risk for PU development
mattress in bed The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning.
18 residents at least one PU category III-IV in the sacral area
mattress in bed The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning. In the group of participants with a PU category III or IV, the Pressure Ulcer Scale for Healing Tool (PUSH) will be used to assess and measure change in PU status. The score on the PUSH-tool is defined by the surface area of the PU (length x width), the amount of exudate and the type of tissue in the wound bed.

Locations

Country Name City State
Belgium WZC Hof ter Waarbeek Asse Vlaams-Brabant

Sponsors (2)

Lead Sponsor Collaborator
University Ghent Care of Sweden AB

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Brown S, Smith IL, Brown JM, Hulme C, McGinnis E, Stubbs N, Nelson EA, Muir D, Rutherford C, Walker K, Henderson V, Wilson L, Gilberts R, Collier H, Fernandez C, Hartley S, Bhogal M, Coleman S, Nixon JE. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial. Trials. 2016 Dec 20;17(1):604. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pressure ulcer incidence Development of at least 1 Pressure ulcer category II+ during study period using European Pressure Ulcer Advisory Panel (EPUAP) classification system 30 days
Primary Pressure ulcer healing Healing of pressure ulcers category III and IV during the 30-day study period - using the Pressure Ulcer Scale for Healing Tool (PUSH) 30 days
Secondary Comfort perceived comfort and experiences of users of the mattress - using self-developed questionnaire 30 days
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