Actively Recruiting
Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers
Led by Laboratoires RIVADIS · Updated on 2025-07-01
252
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of inclusion
- At risk of developing pressure ulcers, indicated by a Braden Scale score below 18 and clinical judgment
- No existing pressure ulcers at the time of inclusion
- Signed informed consent by patient or legal representative
- Expected stay of at least 35 days (±5 days) in the participating healthcare facility
- Planned use of RIVADOUCE VEGETABLE SKINCARE OIL on pressure-prone areas as part of standard prevention protocol
You will not qualify if you...
- Use or planned use of multilayer dressings on pressure-prone areas treated with the study product
- End-of-life patients with life expectancy less than 3 months
- Patients not covered by social health insurance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Multiples facilities
Multiple Locations, France
Actively Recruiting
Research Team
R
Renaud Urbinelli
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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