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Completed

NCT Number: NCT03597750

Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Woonzorgcentrum Zonnetij, Aartselaar, Antwerpen, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repose®

Device
  • Repose® Mattress
  • Repose® Cushion
  • Repose® Wedge or Foot Protectors

Primary outcomes

  1. Pressure ulcer incidence (Cat. II+)

    Time frame: 14 days

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

Secondary outcomes

  1. Patient experiences and perceptions using a static air mattress

    Time frame: 14 days

    Patients experiences and perceptions of comfort using static air support devices and alternating-pressure mattresses. Patient acceptability [tolerance, (sleep) comfort, pain)

  2. Caretakers perceptions of barriers and facilitators to use static air mattress

    Time frame: 14 days

    Nurses acceptability [barriers and facilitators].

  3. Incidence of incontinence-associated dermatitis (IAD)

    Time frame: 14 days

    Development of at least 1 IAD during study period

  4. Cost of the intervention (Repose) versus the standard care (Alternating)

    Time frame: 14 days

    Economic measures (from an organizational and patient perspective)

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Collaborators

  • Frontier Medical Group, UK

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 24, 2018
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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