NCT07045480

Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers

Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers: Observational Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 252 (estimated)
• Sponsor: Laboratoires RIVADIS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, non-interventional, multicenter, post-market clinical follow-up (PMCF) study conducted in real-life conditions to assess the clinical performance and safety of RIVADOUCE VEGETABLE SKINCARE OIL in the prevention of pressure ulcers (PUs) in at-risk adult patients. The product is intended to be applied through effleurage (gentle manual application without pressure) to pressure-prone skin areas as part of standard pressure ulcer prevention protocols. A total of 252 adult patients, with a Braden Scale score \<18 and no existing pressure ulcers at baseline, will be included across 10 to 20 French healthcare centers (e.g., rehabilitation units, long-term care facilities, or nursing homes). Participants will be followed for 35 ± 5 days. The primary endpoint is the proportion of patients developing at least one stage 1 or higher pressure ulcer (per NPUAP 2014/2019 classification) on treated areas (e.g., sacrum, heels, ischial and trochanteric regions). Secondary endpoints include the time to onset, progression of any developed ulcers, adverse events (AEs), device-related adverse events, and product usage compliance. This PMCF study is required for the renewal of CE certification under the EU Medical Device Regulation (MDR) 2017/745, and is designed according to ISO 14155:2020 standards. The study will provide updated clinical evidence on the device's safety and performance within its intended use.

Conditions

• Pressure Ulcer Prevention

Timeline

• Start date: 2025-04-04
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-07-01
• Last updated: 2025-07-01

Locations

1 site across 1 country: France