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.
Age ≥ 18 years at the time of inclusion.
At risk of developing pressure ulcers, as determined by clinical judgment and a Braden Scale score <18.
No existing pressure ulcer at the time of inclusion.
Informed consent signed by the patient, or by a trusted third party or legal representative (for protected adults), after being informed about the study.
Use or planned use of multilayer dressings on the pressure-prone areas to be treated with the study product.
End-of-life patients, defined as having an estimated life expectancy of less than 3 months.
Patients who are not covered by social health insurance.
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France