Pressure Ulcer Prevention
Conditions
Keywords
Effleurage, Pressure Ulcer, Topical Emollient, Post-Market Clinical Follow-Up, Rivadouce
Brief 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.
Interventions
None listed
Sponsors
Laboratoires RIVADIS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Expected length of stay ≥ 35 days ±5 days in the participating facility. * Planned use of RIVADOUCE VEGETABLE SKINCARE OIL on one or more pressure-prone areas as part of the facility's standard pressure ulcer prevention protocol.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Pressure Ulcers on Treated Areas | Day 0 to Day 35 (±5 days) | Proportion of patients who develop at least one stage ≥1 pressure ulcer (per NPUAP classification 2014/2019) between Day 0 and Day 35 (±5 days) on areas treated with RIVADOUCE VEGETABLE SKINCARE OIL (e.g., sacrum, ischium, trochanter, heels, elbows, spine). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Onset of First Pressure Ulcer on Treated Areas | Day 0 to Day 35 (±5 days) | Number of days from baseline (Day 0) to first occurrence of a stage ≥1 pressure ulcer on a treated zone. |
| Occurrence of Adverse Events Related to the Device | Day 0 to Day 35 (±5 days) | Assessment of whether the oil was applied according to the protocol-defined frequency, zones, and method (effleurage). |
Countries
France
Contacts
Primary ContactRenaud Urbinelli
Outcome results
None listed