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Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress : Observational Study
The aim of the study is to determine the clinical value of using a powered alternating pressure air overlay 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 between 15 and 20 hours per day on a specific P-APAM will be included. The study will be conducted in nursing homes, and in long-stay geriatrics department. Patients will be 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 will develop at least one PI of at least stage 2 on the sacrum, spine, or heel between day 0 and day 35 . Secondary endpoints are patient assessments of comfort, caregiver satisfaction, mattress noise level, and mattress safety.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Multiples Facilities
Multiple Locations, France
Start Date
July 17, 2024
Primary Completion Date
June 30, 2025
Completion Date
June 30, 2025
Last Updated
January 14, 2025
80
ESTIMATED participants
Use of a powered alternating pressure air mattress
DEVICE
Lead Sponsor
Nausicaa Medical
Collaborators
NCT07425418
NCT05496296
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06330506