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

Primary Purpose

Pressure Ulcer, Pressure Injury, Pressure Sore

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Repose®
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Ulcer focused on measuring Static air support devices, Alternating-pressure devices, High risk population, Elderly, Prevention

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Woonzorgcentrum Zonnetij
  • Woonzorgcentrum Zonnewende
  • Woonzorgcentrum De Mick
  • Woonzorgcentrum Sint-Maria
  • Woonzorgcentrum Veilige Have
  • Woonzorgcentrum Sint-Jozef
  • Woonzorgcentrum De Vijvers
  • Woonzorgcentrum Meulenbroek
  • Woonzorgcentrum Heilig Hart
  • Woonzorgcentrum Egmont
  • Woonzorgcentrum Sint-Vincentius
  • Woonzorgcentrum Hallenhuis
  • Woonzorgcentrum Minnewater
  • Woonzorgcentrum Ter Potterie
  • Woonzorgcentrum Van Zuylen
  • Woonzorgcentrum Huize Zonnelied
  • Woonzorgcentrum Maria Rustoord
  • Woonzorgcentrum De Plataan
  • Woonzorgcentrum De Pottelberg
  • Woonzorgcentrum Sint-Jozef
  • Woonzorgcentrum OLV Gasthuis
  • Woonzorgcentrum Hof Ten Ijzer
  • Woonzorgcentrum Wintershove
  • Woonzorgcentrum De Meers
  • Woonzorgcentrum Sint-Camillus
  • Woonzorgcentrum Sint-Amand

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Static air support devices (Repose®)

Alternating-pressure devices

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pressure ulcer incidence (Cat. II+)
Development of at least 1 pressure ulcer Cat. II+ during study period

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2017
Last Updated
October 2, 2018
Sponsor
University Ghent
Collaborators
Frontier Medical Group, UK
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1. Study Identification

Unique Protocol Identification Number
NCT03597750
Brief Title
Comparison of Static Air Support Devices (Repose®) and Alternating-Pressure Devices in the Prevention of Pressure Ulcers
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
July 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Ghent
Collaborators
Frontier Medical Group, UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Ulcer, Pressure Injury, Pressure Sore, Bed Sore
Keywords
Static air support devices, Alternating-pressure devices, High risk population, Elderly, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Static air support devices (Repose®)
Arm Type
Experimental
Arm Description
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.
Arm Title
Alternating-pressure devices
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Repose®
Intervention Description
Repose® Mattress Repose® Cushion Repose® Wedge or Foot Protectors
Primary Outcome Measure Information:
Title
Pressure ulcer incidence (Cat. II+)
Description
Development of at least 1 pressure ulcer Cat. II+ during study period
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Patient experiences and perceptions using a static air mattress
Description
Patients experiences and perceptions of comfort using static air support devices and alternating-pressure mattresses. Patient acceptability [tolerance, (sleep) comfort, pain)
Time Frame
14 days
Title
Caretakers perceptions of barriers and facilitators to use static air mattress
Description
Nurses acceptability [barriers and facilitators].
Time Frame
14 days
Title
Incidence of incontinence-associated dermatitis (IAD)
Description
Development of at least 1 IAD during study period
Time Frame
14 days
Title
Cost of the intervention (Repose) versus the standard care (Alternating)
Description
Economic measures (from an organizational and patient perspective)
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitri Beeckman, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
Woonzorgcentrum Zonnetij
City
Aartselaar
State/Province
Antwerpen
Country
Belgium
Facility Name
Woonzorgcentrum Zonnewende
City
Aartselaar
State/Province
Antwerpen
Country
Belgium
Facility Name
Woonzorgcentrum De Mick
City
Brasschaat
State/Province
Antwerpen
Country
Belgium
Facility Name
Woonzorgcentrum Sint-Maria
City
Brecht
State/Province
Antwerpen
Country
Belgium
Facility Name
Woonzorgcentrum Veilige Have
City
Aalter
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Sint-Jozef
City
Assenede
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum De Vijvers
City
Gentbrugge
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Meulenbroek
City
Hamme
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Heilig Hart
City
Oudenaarde
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Egmont
City
Zottegem
State/Province
Oost-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Sint-Vincentius
City
Avelgem
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Hallenhuis
City
Brugge
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Minnewater
City
Brugge
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Ter Potterie
City
Brugge
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Van Zuylen
City
Brugge
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Huize Zonnelied
City
Ieper
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Maria Rustoord
City
Ingelmunster
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum De Plataan
City
Izegem
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum De Pottelberg
City
Kortrijk
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Sint-Jozef
City
Kortrijk
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum OLV Gasthuis
City
Poperinge
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Hof Ten Ijzer
City
Reninge
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Wintershove
City
Vlamertinge
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum De Meers
City
Waregem
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Sint-Camillus
City
Wevelgem
State/Province
West-Vlaanderen
Country
Belgium
Facility Name
Woonzorgcentrum Sint-Amand
City
Zwevegem
State/Province
West-Vlaanderen
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26333288
Citation
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.
Results Reference
background
PubMed Identifier
27391289
Citation
Serraes 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.
Results Reference
background
Links:
URL
http://www.ucvvgent.be
Description
Website of the research group

Learn more about this trial

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

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