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

Laboratoires RIVADIS

Status: Enrolling

Conditions: Pressure Ulcer Prevention

Study type: Observational

Funder types: Industry

Identifiers

NCT07045480

2024-A01643-44

Details and patient eligibility

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.

Enrollment: 252 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

252 participants in 1 patient group

Rivadouce Group

Description:

Patients aged 18 years and older, at risk of developing pressure ulcers (Braden Scale \<18), without existing ulcers at baseline, and for whom RIVADOUCE VEGETABLE SKINCARE OIL is applied via effleurage as part of routine clinical practice. Patients are followed for 35 ± 5 days to monitor the incidence of pressure ulcers and adverse events.