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

Pressure Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03597750
• Other study ID #: EC/2017/0266
• Secondary ID: B670201731706
• Status: Completed
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: July 15, 2018

Study information

• Verified date: October 2018
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: July 15, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bed Sore
• Crush Injuries
• Pressure Injury
• Pressure Sore
• Pressure Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
Belgium	Woonzorgcentrum Veilige Have	Aalter	Oost-Vlaanderen
Belgium	Woonzorgcentrum Zonnetij	Aartselaar	Antwerpen
Belgium	Woonzorgcentrum Zonnewende	Aartselaar	Antwerpen
Belgium	Woonzorgcentrum Sint-Jozef	Assenede	Oost-Vlaanderen
Belgium	Woonzorgcentrum Sint-Vincentius	Avelgem	West-Vlaanderen
Belgium	Woonzorgcentrum De Mick	Brasschaat	Antwerpen
Belgium	Woonzorgcentrum Sint-Maria	Brecht	Antwerpen
Belgium	Woonzorgcentrum Hallenhuis	Brugge	West-Vlaanderen
Belgium	Woonzorgcentrum Minnewater	Brugge	West-Vlaanderen
Belgium	Woonzorgcentrum Ter Potterie	Brugge	West-Vlaanderen
Belgium	Woonzorgcentrum Van Zuylen	Brugge	West-Vlaanderen
Belgium	Woonzorgcentrum De Vijvers	Gentbrugge	Oost-Vlaanderen
Belgium	Woonzorgcentrum Meulenbroek	Hamme	Oost-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 Heilig Hart	Oudenaarde	Oost-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 Egmont	Zottegem	Oost-Vlaanderen
Belgium	Woonzorgcentrum Sint-Amand	Zwevegem	West-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Frontier Medical Group, UK

Country where clinical trial is conducted

Belgium, 

References & 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;(9):CD001735. doi: 10.1002/14651858.CD001735.pub5. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure ulcer incidence (Cat. II+)	Development of at least 1 pressure ulcer Cat. II+ during study period	14 days
Secondary	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)	14 days
Secondary	Caretakers perceptions of barriers and facilitators to use static air mattress	Nurses acceptability [barriers and facilitators].	14 days
Secondary	Incidence of incontinence-associated dermatitis (IAD)	Development of at least 1 IAD during study period	14 days
Secondary	Cost of the intervention (Repose) versus the standard care (Alternating)	Economic measures (from an organizational and patient perspective)	14 days

External Links

•   Website of the research group