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

University Ghent

Status: Completed

Conditions: Pressure Ulcer; Pressure Injury; Pressure Sore; Bed Sore

Treatments: Device: CuroCell S.A.M. ® pro mattress

Study type: Interventional

Funder types: Other

Identifiers

NCT03725787

EC/2018/0091

B670201835095 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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180 participants in 1 patient group

CuroCell S.A.M. ® pro mattress

Experimental group

Description:

Mattresses of eligible participants will be replaced by a static air pressure redistribution mattress (CuroCell S.A.M. ® Pro).

Treatment:

Device: CuroCell S.A.M. ® pro mattress