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Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress

Pressure Injury Clinical Trial

Official title:
Prevention of Pressure Ulcers in Patients at Medium to High Risk of Developing Pressure Ulcers and Using the DOMUS 4 / AUTO Motorized Air Mattress: Non-interventional Study

Clinical Trial Summary

The aim of the study is to determine the clinical value of using a powered alternating pressure air mattress (P-APAM) in the prevention of pressure injury (PI) in patients at medium to high risk. This study is noncomparative, observational study. Patients older than 18 years of age, with a medium to high risk of PI, without PI, up during the day, and lying more than 15 hours a day on a specific P-APAM were included. The study was conducted in nursing homes, and in long-stay geriatrics department. Patients are followed up for 35 days. The use of the P-APAM is associated with the usual PI prevention measures. The primary outcome is the percentage of patients who developed between day 0 and day 35 at least one PI of at least stage 2 on the sacrum, spine, or heel. Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05472974
Study type Observational
Source Wellell France
Contact
Status Completed
Phase
Start date September 17, 2018
Completion date July 22, 2019
View Details
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