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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pressure Ulcer, Pressure Injury, Pressure Sore, Bed Sore

Intervention / Treatment
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* Device: CuroCell S.A.M. ® pro mattress


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CuroCell S.A.M. ® pro mattress<br>Mattresses of eligible participants will be replaced by a static air pressure redistribution mattress (CuroCell S.A.M. ® Pro). | Device: CuroCell S.A.M. ® pro mattress<br>* During 30 days, participants will use the static air mattress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Static air support surface, Support device, Elderly, Prevention