Clinical Trials Directory

Trials / Completed

CompletedNCT03725787

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
Phase
N/A
Study type
Interventional
Enrollment
180 (actual)
Sponsor
University Ghent · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICECuroCell S.A.M. ® pro mattressDuring 30 days, participants will use the static air mattress.

Timeline

Start date
2018-03-04
Primary completion
2019-02-06
Completion
2020-10-06
First posted
2018-10-31
Last updated
2021-05-06

Locations

8 sites across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03725787. Inclusion in this directory is not an endorsement.