Actively Recruiting
Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers: Observational Study
Led by Laboratoires RIVADIS · Updated on 2025-07-01
252
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance and safety of RIVADOUCE VEGETABLE SKINCARE OIL in preventing pressure ulcers in adults at risk. This observational post-market clinical follow-up study is conducted in real-life settings across multiple centers, focusing on patients with a Braden Scale score under 18 and no existing pressure ulcers. The study follows international standards and aims to gather updated evidence for device certification under EU regulations. The skincare oil is applied gently by effleurage to pressure-prone areas such as the sacrum, heels, ischial, and trochanteric regions as part of routine prevention protocols. A total of 252 adult patients will be enrolled and followed for 35 days, with a small allowance of 5 days variation. The study does not involve randomization or control groups, focusing on real-life product use and monitoring. Participants will be monitored for the development of pressure ulcers, timing of their onset, progression, and any adverse events potentially related to the device. Compliance with product use will also be tracked. The primary outcome is the proportion of patients developing at least one pressure ulcer of stage 1 or higher during the study period. Safety and performance data collected will help support ongoing product approval and clinical use.
CONDITIONS
Brief 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, determined by clinical judgment and a Braden Scale score less than 18
- No existing pressure ulcer at the time of inclusion
- Signed informed consent by the patient or legal representative
- Expected length of stay of at least 35 days (plus or minus 15 days) in the participating facility
- Planned use of RIVADOUCE VEGETABLE SKINCARE OIL on one or more 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 to be treated with the product
- End-of-life patients with an estimated 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 35 ± 5 days
Participants who undergo routine care with RIVADOUCE VEGETABLE SKINCARE OIL applied via effleurage are observed to monitor the incidence of pressure ulcers and adverse events.
Visits occur as part of routine clinical practice over the monitoring period
Trial Site Locations
Total: 1 location
1
Multiples facilities
Multiple Locations, France
Actively Recruiting
Research Team
R
Renaud Urbinelli
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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