Pressure UlcerNCT03597750
Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers
A study testing Repose® in people with Pressure Ulcer and Pressure Injury, run by University Ghent at 26 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pressure Ulcer, Pressure Injury, Pressure Sore
- What is being tested?
- Repose®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 26 sitesBelgium
- Study dates
- 19 Apr 2017to 15 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Belgium26 sites
Woonzorgcentrum Veilige Have
Aalter, Oost-Vlaanderen
Woonzorgcentrum Zonnetij
Aartselaar, Antwerpen
Woonzorgcentrum Zonnewende
Aartselaar, Antwerpen
Woonzorgcentrum Sint-Jozef
Assenede, Oost-Vlaanderen
Woonzorgcentrum Sint-Vincentius
Avelgem, West-Vlaanderen
Woonzorgcentrum De Mick
Brasschaat, Antwerpen
Woonzorgcentrum Sint-Maria
Brecht, Antwerpen
Woonzorgcentrum Hallenhuis
Bruges, West-Vlaanderen
Woonzorgcentrum Minnewater
Bruges, West-Vlaanderen
Woonzorgcentrum Ter Potterie
Bruges, West-Vlaanderen
Woonzorgcentrum Van Zuylen
Bruges, West-Vlaanderen
Woonzorgcentrum De Vijvers
Gentbrugge, Oost-Vlaanderen
Woonzorgcentrum Meulenbroek
Hamme, Oost-Vlaanderen
Woonzorgcentrum Huize Zonnelied
Ieper, West-Vlaanderen
Woonzorgcentrum Maria Rustoord
Ingelmunster, West-Vlaanderen
Woonzorgcentrum De Plataan
Izegem, West-Vlaanderen
Woonzorgcentrum De Pottelberg
Kortrijk, West-Vlaanderen
Woonzorgcentrum Sint-Jozef
Kortrijk, West-Vlaanderen
Woonzorgcentrum Heilig Hart
Oudenaarde, Oost-Vlaanderen
Woonzorgcentrum OLV Gasthuis
Poperinge, West-Vlaanderen
Woonzorgcentrum Hof Ten Ijzer
Reninge, West-Vlaanderen
Woonzorgcentrum Wintershove
Vlamertinge, West-Vlaanderen
Woonzorgcentrum De Meers
Waregem, West-Vlaanderen
Woonzorgcentrum Sint-Camillus
Wevelgem, West-Vlaanderen
Woonzorgcentrum Egmont
Zottegem, Oost-Vlaanderen
Woonzorgcentrum Sint-Amand
Zwevegem, West-Vlaanderen
About this study
Official 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
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.
- Conditions
- Pressure Ulcer, Pressure Injury, Pressure Sore, Bed Sore
- Being tested
- Repose®
- Keywords
- Static air support devices, Alternating-pressure devices, High risk population, Elderly, Prevention
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repose®Device
- Repose® Mattress
- Repose® Cushion
- Repose® Wedge or Foot Protectors
| Study group | Role | What they receive |
|---|---|---|
| Static air support devices (Repose®) | Experimental | 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. Receives: Device: Repose® |
| Alternating-pressure devices | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Pressure ulcer incidence (Cat. II+)
Development of at least 1 pressure ulcer Cat. II+ during study period
Measured: 14 days
Secondary outcomes (4)
Patient experiences and perceptions using a static air mattress
Patients experiences and perceptions of comfort using static air support devices and alternating-pressure mattresses. Patient acceptability [tolerance, (sleep) comfort, pain)
Measured: 14 days
Caretakers perceptions of barriers and facilitators to use static air mattress
Nurses acceptability [barriers and facilitators].
Measured: 14 days
Incidence of incontinence-associated dermatitis (IAD)
Development of at least 1 IAD during study period
Measured: 14 days
Cost of the intervention (Repose) versus the standard care (Alternating)
Economic measures (from an organizational and patient perspective)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start19 Apr 2017
- Primary completion15 Jul 2018
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Frontier Medical Group, UK
- Responsible party
- Principal investigator, UCVV, University Ghent
- Investigators
- Dimitri Beeckman, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597750
- Sponsor's protocol ID
- EC/2017/0266
- Other IDs
- B670201731706
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2017
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
McInnes E, Jammali-Blasi A, Bell-Syer SE, Dumville JC, Middleton V, Cullum N. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2015 Sep 3;2015(9):CD001735. doi: 10.1002/14651858.CD001735.pub5.
PubMed 26333288Serraes B, Beeckman D. Static Air Support Surfaces to Prevent Pressure Injuries: A Multicenter Cohort Study in Belgian Nursing Homes. J Wound Ostomy Continence Nurs. 2016 Jul-Aug;43(4):375-8. doi: 10.1097/WON.0000000000000244.
PubMed 27391289
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03597750
- Acronym / sponsor ID
- EC/2017/0266
- Conditions
- Pressure Ulcer, Pressure Injury, Pressure Sore, Bed Sore
- Keywords
- Static air support devices, Alternating-pressure devices, High risk population, Elderly, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Frontier Medical Group, UK
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static air support devices (Repose®) | Experimental | Device: 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. |
| Alternating-pressure devices | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repose®* Repose® Mattress * Repose® Cushion * Repose® Wedge or Foot Protectors | Device | Static air support devices (Repose®) |
Primary outcome
Pressure ulcer incidence (Cat. II+)
Time frame: 14 days
Development of at least 1 pressure ulcer Cat. II+ during study period
4 secondary outcomes
Patient experiences and perceptions using a static air mattress
Time frame: 14 days
Caretakers perceptions of barriers and facilitators to use static air mattress
Time frame: 14 days
Incidence of incontinence-associated dermatitis (IAD)
Time frame: 14 days
Cost of the intervention (Repose) versus the standard care (Alternating)
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Background: PubMed 26333288McInnes E, Jammali-Blasi A, Bell-Syer SE, Dumville JC, Middleton V, Cullum N. Support surfaces for pressure ulcer prevention. Cochrane Database Syst Rev. 2015 Sep 3;2015(9):CD001735. doi: 10.1002/14651858.CD001735.pub5.
- Background: PubMed 27391289Serraes B, Beeckman D. Static Air Support Surfaces to Prevent Pressure Injuries: A Multicenter Cohort Study in Belgian Nursing Homes. J Wound Ostomy Continence Nurs. 2016 Jul-Aug;43(4):375-8. doi: 10.1097/WON.0000000000000244.
- Website of the research groupLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
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The Effectiveness of a Caregiver-Based Multicomponent Intervention to Prevent Pressure Ulcers in Home-Cared-For Individuals With Dementia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dimitri Beeckman, PhD principal investigator
University Ghent
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repose® in people with Pressure Ulcer and Pressure Injury, run by University Ghent at 26 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure ulcer incidence (Cat. II+) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03597750, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.