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

NCT03597750 | Completed

• 2 other identifiers: EC/2017/0266B670201731706
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 26

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

Keywords

Static air support devices; Alternating-pressure devices; High risk population; Elderly; Prevention

Outcome Measures

Primary Outcomes (1)

• Pressure ulcer incidence (Cat. II+)

  Development of at least 1 pressure ulcer Cat. II+ during study period

  14 days

Secondary Outcomes (4)

• Patient experiences and perceptions using a static air mattress

  14 days

• Caretakers perceptions of barriers and facilitators to use static air mattress

  14 days

• Incidence of incontinence-associated dermatitis (IAD)

  14 days

• Cost of the intervention (Repose) versus the standard care (Alternating)

  14 days

Study Arms (2)

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.

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.

Interventions

Repose® DEVICE

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

Static air support devices (Repose®)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• Frontier Medical Group, UK: collaborator

Study Sites (26)

Woonzorgcentrum Zonnetij

Aartselaar, Antwerpen, Belgium

Location

Woonzorgcentrum Zonnewende

Aartselaar, Antwerpen, Belgium

Location

Woonzorgcentrum De Mick

Brasschaat, Antwerpen, Belgium

Location

Woonzorgcentrum Sint-Maria

Brecht, Antwerpen, Belgium

Location

Woonzorgcentrum Veilige Have

Aalter, Oost-Vlaanderen, Belgium

Location

Woonzorgcentrum Sint-Jozef

Assenede, Oost-Vlaanderen, Belgium

Location

Woonzorgcentrum De Vijvers

Gentbrugge, Oost-Vlaanderen, Belgium

Location

Woonzorgcentrum Meulenbroek

Hamme, Oost-Vlaanderen, Belgium

Location

Woonzorgcentrum Heilig Hart

Oudenaarde, Oost-Vlaanderen, Belgium

Location

Woonzorgcentrum Egmont

Zottegem, Oost-Vlaanderen, Belgium

Location

Woonzorgcentrum Sint-Vincentius

Avelgem, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Hallenhuis

Bruges, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Minnewater

Bruges, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Ter Potterie

Bruges, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Van Zuylen

Bruges, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Huize Zonnelied

Ieper, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Maria Rustoord

Ingelmunster, West-Vlaanderen, Belgium

Location

Woonzorgcentrum De Plataan

Izegem, West-Vlaanderen, Belgium

Location

Woonzorgcentrum De Pottelberg

Kortrijk, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Sint-Jozef

Kortrijk, West-Vlaanderen, Belgium

Location

Woonzorgcentrum OLV Gasthuis

Poperinge, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Hof Ten Ijzer

Reninge, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Wintershove

Vlamertinge, West-Vlaanderen, Belgium

Location

Woonzorgcentrum De Meers

Waregem, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Sint-Camillus

Wevelgem, West-Vlaanderen, Belgium

Location

Woonzorgcentrum Sint-Amand

Zwevegem, West-Vlaanderen, Belgium

Location

Related Publications (2)

• 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.

  PMID: 26333288 BACKGROUND

• 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.

  PMID: 27391289 BACKGROUND

Related Links

• Website of the research group

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dimitri Beeckman, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Centre for Nursing and Midwifery

Study Record Dates

• First Submitted: October 23, 2017
• First Posted: July 24, 2018
• Study Start: April 19, 2017
• Primary Completion: July 15, 2018
• Study Completion: July 15, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-10

Locations

BE (26)