NCT06465225

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Nausicaa Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-17
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-06-18
• Last updated: 2025-01-14

Locations

1 site across 1 country: France