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

Laboratoires RIVADIS252 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

252

Conditions

Pressure Ulcer Prevention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of Pressure Ulcers on Treated Areas

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).

Time frame: Day 0 to Day 35 (±5 days)

Secondary Outcomes

Time to Onset of First Pressure Ulcer on Treated Areas

Number of days from baseline (Day 0) to first occurrence of a stage ≥1 pressure ulcer on a treated zone.

Time frame: Day 0 to Day 35 (±5 days)

Occurrence of Adverse Events Related to the Device

Assessment of whether the oil was applied according to the protocol-defined frequency, zones, and method (effleurage).

Time frame: Day 0 to Day 35 (±5 days)

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts