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

October 2, 2018 updated by: UCVV, University Ghent

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Antwerpen
      • Aartselaar, Antwerpen, Belgium
        • Woonzorgcentrum Zonnetij
      • Aartselaar, Antwerpen, Belgium
        • Woonzorgcentrum Zonnewende
      • Brasschaat, Antwerpen, Belgium
        • Woonzorgcentrum De Mick
      • Brecht, Antwerpen, Belgium
        • Woonzorgcentrum Sint-Maria
    • Oost-Vlaanderen
      • Aalter, Oost-Vlaanderen, Belgium
        • Woonzorgcentrum Veilige Have
      • Assenede, Oost-Vlaanderen, Belgium
        • Woonzorgcentrum Sint-Jozef
      • Gentbrugge, Oost-Vlaanderen, Belgium
        • Woonzorgcentrum De Vijvers
      • Hamme, Oost-Vlaanderen, Belgium
        • Woonzorgcentrum Meulenbroek
      • Oudenaarde, Oost-Vlaanderen, Belgium
        • Woonzorgcentrum Heilig Hart
      • Zottegem, Oost-Vlaanderen, Belgium
        • Woonzorgcentrum Egmont
    • West-Vlaanderen
      • Avelgem, West-Vlaanderen, Belgium
        • Woonzorgcentrum Sint-Vincentius
      • Brugge, West-Vlaanderen, Belgium
        • Woonzorgcentrum Hallenhuis
      • Brugge, West-Vlaanderen, Belgium
        • Woonzorgcentrum Minnewater
      • Brugge, West-Vlaanderen, Belgium
        • Woonzorgcentrum Ter Potterie
      • Brugge, West-Vlaanderen, Belgium
        • Woonzorgcentrum Van Zuylen
      • Ieper, West-Vlaanderen, Belgium
        • Woonzorgcentrum Huize Zonnelied
      • Ingelmunster, West-Vlaanderen, Belgium
        • Woonzorgcentrum Maria Rustoord
      • Izegem, West-Vlaanderen, Belgium
        • Woonzorgcentrum De Plataan
      • Kortrijk, West-Vlaanderen, Belgium
        • Woonzorgcentrum De Pottelberg
      • Kortrijk, West-Vlaanderen, Belgium
        • Woonzorgcentrum Sint-Jozef
      • Poperinge, West-Vlaanderen, Belgium
        • Woonzorgcentrum OLV Gasthuis
      • Reninge, West-Vlaanderen, Belgium
        • Woonzorgcentrum Hof Ten Ijzer
      • Vlamertinge, West-Vlaanderen, Belgium
        • Woonzorgcentrum Wintershove
      • Waregem, West-Vlaanderen, Belgium
        • Woonzorgcentrum De Meers
      • Wevelgem, West-Vlaanderen, Belgium
        • Woonzorgcentrum Sint-Camillus
      • Zwevegem, West-Vlaanderen, Belgium
        • Woonzorgcentrum Sint-Amand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Static air support devices (Repose®)

Alternating-pressure devices will be replaced by static air support devices (Repose®) during 14 days:

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

The frequency of repositioning remains unchanged.

  • Repose® Mattress
  • Repose® Cushion
  • Repose® Wedge or Foot Protectors
NO_INTERVENTION: Alternating-pressure devices

Instead of replacing the alternating-pressure devices by static air support devices (Repose®), the residents remain on their alternating-pressure devices.

The frequency of repositioning remains unchanged.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pressure ulcer incidence (Cat. II+)
Time Frame: 14 days
Development of at least 1 pressure ulcer Cat. II+ during study period
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
14 days
Caretakers perceptions of barriers and facilitators to use static air mattress
Time Frame: 14 days
Nurses acceptability [barriers and facilitators].
14 days
Incidence of incontinence-associated dermatitis (IAD)
Time Frame: 14 days
Development of at least 1 IAD during study period
14 days
Cost of the intervention (Repose) versus the standard care (Alternating)
Time Frame: 14 days
Economic measures (from an organizational and patient perspective)
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 19, 2017

Primary Completion (ACTUAL)

July 15, 2018

Study Completion (ACTUAL)

July 15, 2018

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

July 13, 2018

First Posted (ACTUAL)

July 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2018

Last Update Submitted That Met QC Criteria

October 2, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • EC/2017/0266
  • B670201731706 (OTHER: Ethics Committee UZ Gent)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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