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

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.

Recruiting

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Key information

Conditions

Pressure Ulcer Prevention Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Multiples facilities

Multiple Locations, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Incidence of Pressure Ulcers on Treated Areas

Time frame: 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 outcomes

Time to Onset of First Pressure Ulcer on Treated Areas

Time frame: 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

Time frame: Day 0 to Day 35 (±5 days)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Renaud Urbinelli

CONTACT

[email protected]

+33658687286

Sponsors and collaborators

Lead sponsor

Laboratoires RIVADIS

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 1, 2025
Registry last updated: Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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