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RECRUITING
NCT06465225

Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress

Sponsor: Nausicaa Medical

View on ClinicalTrials.gov

Summary

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.

Official title: Prevention of Pressure Ulcers in Patients at Medium to High Risk of Pressure Ulcers Using the R'GO SOINS Overlay Mattress : Observational Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2024-07-17

Completion Date

2025-06-30

Last Updated

2025-01-14

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Use of a powered alternating pressure air mattress

Patients with a medium to high risk of developing pressure injury, without pressure injury, up during the day and lying between 15 and 20 hours per day will ly a on a R'GO Soins overlay mattress

Locations (1)

Multiples Facilities

Multiple Locations, France