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Clinical Trials/NCT03597750
NCT03597750
Completed
Not Applicable

Pressure Ulcer Prevention Using Static Air Support Devices (Repose®) Versus Alternating-Pressure Devices in a High Risk Population in Nursing Homes: A Multi-Center Prospective Randomized Controlled Trial and Qualitative Study

University Ghent25 sites in 1 country308 target enrollmentApril 19, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pressure Ulcer
Sponsor
University Ghent
Enrollment
308
Locations
25
Primary Endpoint
Pressure ulcer incidence (Cat. II+)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Maintaining and improving skin health are major goals in acute and long-term care. Patients at the extremes of age, the critically ill, medically compromised and those with immobility are at risk for developing several skin disorders, with pressure ulcers (PUs) as one of the most common and mostly preventable ones. Prevalence figures of PUs vary between 6.4% and 31.4%. PUs are described as localised injuries to the skin and/or underlying tissue, usually over a bony prominence, as a result of pressure or pressure combined with shear. Prevention of PUs is internationally seen to be a key quality indicator of care. To prevent PUs, reducing both the amount and the duration of pressure and shear at the pressure points of the body is strongly recommended. One of the interventions to achieving this, is the use of pressure-reducing devices (mattresses, cushions, etc.). Studies that compare the (cost-) effectiveness of different pressure-reducing devices are needed.

The primary aim of this study is to compare the (cost-) effectiveness of pressure ulcer prevention in high risk patients using static air support devices (Repose®) versus alternating-pressure devices. The second aim is to get insight in patients' experiences and perceptions of comfort using static air support devices and alternating-pressure devices. The third aim is to get insight in caretakers' perceptions of barriers and facilitators of the use of static air support devices and alternating-pressure devices and to reveal how these perceptions influence the readiness to use the products in clinical practice.

This randomized controlled trial will be performed in ca. 25 nursing homes in a random sample of 306 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher.

Registry
clinicaltrials.gov
Start Date
April 19, 2017
End Date
July 15, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

UCVV

University Centre for Nursing and Midwifery

University Ghent

Eligibility Criteria

Inclusion Criteria

  • High risk of pressure ulcers (Braden score \< 12) and/or pressure ulcer category 1
  • Currently using alternating-pressure devices
  • Bedbound (\> 8 hours in bed) or chair bound (\> 8 hours in chair)
  • Aged \> 65 years

Exclusion Criteria

  • Pressure ulcer category 2,3,4, deep tissue injury (DTI) or unstageable pressure ulcer
  • Expected length of stay \< 2 weeks
  • End of life care
  • Medical contraindication for use of static air support devices

Outcomes

Primary Outcomes

Pressure ulcer incidence (Cat. II+)

Time Frame: 14 days

Development of at least 1 pressure ulcer Cat. II+ during study period

Secondary Outcomes

  • Patient experiences and perceptions using a static air mattress(14 days)
  • Cost of the intervention (Repose) versus the standard care (Alternating)(14 days)
  • Incidence of incontinence-associated dermatitis (IAD)(14 days)
  • Caretakers perceptions of barriers and facilitators to use static air mattress(14 days)

Study Sites (25)

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