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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
308

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Belgium
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Device: Repose®
  • 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Ghent

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Frontier Medical Group, UK

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.

General Publications

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 15, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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