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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-04

Study Completion Date

2020-10-06

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.

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Detailed Description

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Conditions

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Pressure Ulcer Pressure Injury Pressure Sore Bed Sore

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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CuroCell S.A.M. ® pro mattress

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

Group Type EXPERIMENTAL

CuroCell S.A.M. ® pro mattress

Intervention Type DEVICE

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

Interventions

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CuroCell S.A.M. ® pro mattress

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

Intervention Type DEVICE

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes