Pressure Ulcer Incidence Cat. II+ on a Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk

Pressure Ulcer Clinical Trial

Official title:

Pressure Ulcer Incidence Cat. II+ on the CuroCell SAM® PRO Static Air Mattress: a Multicenter Cohort Study in Nursing Home Residents at Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725787
• Other study ID #: EC/2018/0091
• Secondary ID: B670201835095
• Status: Completed
• Phase: N/A
• Start date: March 4, 2018
• Est. completion date: October 6, 2020

Study information

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

Clinical Trial Summary

Pressure Ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the Healthcare system, affecting approximately 1 in 20 community patients. International guidelines recommend the use of pressure redistribution support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analyzing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis. Static or reactive overlay mattresses are an example of a low-tech constant low-pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman found a pressure ulcer incidence of 5.1% in patients placed on static air support (mattress overlay, heel wedge and seat cushion) in a high risk population in a nursing home setting in Belgium. The CuroCell SAM PRO (Care of Sweden AB) is a static air mattress overlay system used as prevent and treat pressure ulcers (up to category 3) and for pain therapy. The aim of current study is to measure pressure ulcer incidence on the CuroCell Sam PRO static air mattress in nursing home residents at risk for pressure ulcer development over a 30-day period in Belgium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 6, 2020
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• At risk of pressure ulcer development based on a Braden score = 17
• Bedbound or chair bound
• Aged = 65

Exclusion Criteria:

• Short-stay residents (expected length of stay =14 days)
• End of life care
• Medical contraindication for patient repositioning/turning
• Pressure ulcer Cat. II+ present on initial evaluation

Related Conditions & MeSH terms

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

Intervention

Device:
• CuroCell S.A.M. ® pro mattress
During 30 days, participants will use the static air mattress.

Locations

Country	Name	City	State
Belgium	WZC Sint-Vincentius	Deinze	Oost-Vlaanderen
Belgium	WZC Sint-Jozef	Gent	Oost-Vlaanderen
Belgium	WZC Sint-Vincentius	Kaprijke	Oost-Vlaanderen
Belgium	WZC Sint-Rafaël	Liedekerke	Vlaams-Brabant
Belgium	WZC Brugse Vaart	Mariakerke	Oost-Vlaanderen
Belgium	Provinciaal Zorgcentrum Lemberge	Merelbeke	Oost-Vlaanderen
Belgium	WZC Onderdale	Ursel	Oost-Vlaanderen
Belgium	Residentie Vroonstalle	Wondelgem	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	Care of Sweden

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

Brown S, Smith IL, Brown JM, Hulme C, McGinnis E, Stubbs N, Nelson EA, Muir D, Rutherford C, Walker K, Henderson V, Wilson L, Gilberts R, Collier H, Fernandez C, Hartley S, Bhogal M, Coleman S, Nixon JE. Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2): study protocol for a randomised controlled trial. Trials. 2016 Dec 20;17(1):604. — View Citation

Levy A, Kopplin K; BS, Gefen A. Computer simulations of efficacy of air-cell-based cushions in protecting against reoccurrence of pressure ulcers. J Rehabil Res Dev. 2014;51(8):1297-319. doi: 10.1682/JRRD.2014.02.0048. — View Citation

National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel and Pan Pacific Pressure Injury Alliance. Prevention and Treatment of Pressure Ulcers: Quick Reference Guide. Emily Haesler (Ed.). Cambridge Media: Osborne Park, Western Australia; 201.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure ulcer incidence (Cat. II+), (NPUAP classification system)	Development of at least 1 pressure ulcer Cat. II+ during study period, not associated with the use of medical devices	30 days
Secondary	Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)	Development of at least 1 pressure ulcer Cat. I during study period, not associated with the use of medical devices	30 days
Secondary	Comfort of participants (self developed questionnaire)	A quantitative approach to obtain insight in residents' experiences and perceptions of comfort by using a questionnaire	30 days

External Links

•   Website of the research group