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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03725787
Enrollment
180
Registered
2018-10-31
Start date
2018-03-04
Completion date
2020-10-06
Last updated
2021-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bed Sore, Pressure Injury, Pressure Sore, Pressure Ulcer

Keywords

Static air support surface, Support device, Elderly, Prevention

Brief 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.

Interventions

DEVICECuroCell S.A.M. ® pro mattress

During 30 days, participants will use the static air mattress.

Sponsors

Care of Sweden
CollaboratorUNKNOWN
University Ghent
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pressure ulcer incidence (Cat. II+), (NPUAP classification system)30 daysDevelopment of at least 1 pressure ulcer Cat. II+ during study period, not associated with the use of medical devices

Secondary

MeasureTime frameDescription
Incidence rate of Cat. I pressure ulcers, (NPUAP classification system)30 daysDevelopment of at least 1 pressure ulcer Cat. I during study period, not associated with the use of medical devices
Comfort of participants (self developed questionnaire)30 daysA quantitative approach to obtain insight in residents' experiences and perceptions of comfort by using a questionnaire

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026