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

NCT ID: NCT03597750

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 308 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-19
• Study Completion Date: 2018-07-15

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.

Conditions

Pressure Ulcer; Pressure Injury; Pressure Sore; Bed Sore

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Repose®

Intervention Type: DEVICE

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Repose®

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Frontier Medical Group, UK

UNKNOWN

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: lead

Responsible Party

UCVV

University Centre for Nursing and Midwifery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitri Beeckman, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

Woonzorgcentrum Zonnetij

Aartselaar, Antwerpen, Belgium

Woonzorgcentrum Zonnewende

Aartselaar, Antwerpen, Belgium

Woonzorgcentrum De Mick

Brasschaat, Antwerpen, Belgium

Woonzorgcentrum Sint-Maria

Brecht, Antwerpen, Belgium

Woonzorgcentrum Veilige Have

Aalter, Oost-Vlaanderen, Belgium

Woonzorgcentrum Sint-Jozef

Assenede, Oost-Vlaanderen, Belgium

Woonzorgcentrum De Vijvers

Gentbrugge, Oost-Vlaanderen, Belgium

Woonzorgcentrum Meulenbroek

Hamme, Oost-Vlaanderen, Belgium

Woonzorgcentrum Heilig Hart

Oudenaarde, Oost-Vlaanderen, Belgium

Woonzorgcentrum Egmont

Zottegem, Oost-Vlaanderen, Belgium

Woonzorgcentrum Sint-Vincentius

Avelgem, West-Vlaanderen, Belgium

Woonzorgcentrum Hallenhuis

Bruges, West-Vlaanderen, Belgium

Woonzorgcentrum Minnewater

Bruges, West-Vlaanderen, Belgium

Woonzorgcentrum Ter Potterie

Bruges, West-Vlaanderen, Belgium

Woonzorgcentrum Van Zuylen

Bruges, West-Vlaanderen, Belgium

Woonzorgcentrum Huize Zonnelied

Ieper, West-Vlaanderen, Belgium

Woonzorgcentrum Maria Rustoord

Ingelmunster, West-Vlaanderen, Belgium

Woonzorgcentrum De Plataan

Izegem, West-Vlaanderen, Belgium

Woonzorgcentrum De Pottelberg

Kortrijk, West-Vlaanderen, Belgium

Woonzorgcentrum Sint-Jozef

Kortrijk, West-Vlaanderen, Belgium

Woonzorgcentrum OLV Gasthuis

Poperinge, West-Vlaanderen, Belgium

Woonzorgcentrum Hof Ten Ijzer

Reninge, West-Vlaanderen, Belgium

Woonzorgcentrum Wintershove

Vlamertinge, West-Vlaanderen, Belgium

Woonzorgcentrum De Meers

Waregem, West-Vlaanderen, Belgium

Woonzorgcentrum Sint-Camillus

Wevelgem, West-Vlaanderen, Belgium

Woonzorgcentrum Sint-Amand

Zwevegem, West-Vlaanderen, Belgium

Countries

Belgium

References

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.

Reference Type: BACKGROUND

PMID: 26333288 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27391289 (View on PubMed)

Related Links

http://www.ucvvgent.be

Website of the research group

Other Identifiers

B670201731706

Identifier Type: OTHER

Identifier Source: secondary_id

EC/2017/0266

Identifier Type: -

Identifier Source: org_study_id