Preventing pressure ulcers with gentle application of Rivadouce vegetable skincare oil

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

This project will test whether gently massaging Rivadouce vegetable skincare oil onto pressure-prone skin helps prevent pressure ulcers in adults at risk.

Quick facts

• Study type: Observational
• Enrollment: 252 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Laboratoires RIVADIS (industry)
• Locations: 1 site (Multiple Locations)
• Trial ID: NCT07045480 on ClinicalTrials.gov

What this trial studies

This is a prospective, non-interventional multicenter post-market follow-up conducted in real-life conditions across French care facilities. Adults at risk (Braden score <18) with no existing pressure ulcers will receive the product applied by effleurage to pressure-prone sites as part of routine prevention measures and be followed for 35 ± 5 days. The primary outcome is the proportion of patients developing at least one stage 1 or higher pressure ulcer on treated areas using NPUAP classification. The study enrolls about 252 patients across 10–20 centers to collect clinical performance and safety data for the marketed product.

Who should consider this trial

Good fit: Adults at risk for pressure ulcers (Braden score <18), without existing pressure ulcers, who will receive the oil as part of their facility's prevention protocol and will remain in the facility for about 35 days are ideal candidates.

Not a fit: Patients who already have pressure ulcers, are at end of life, plan to use multilayer dressings on target areas, or are not covered by social health insurance are unlikely to be eligible or to benefit from this follow-up.

Why it matters

Potential benefit: If successful, the product could reduce new pressure ulcers by offering a simple topical preventive option that integrates into routine care.

How similar studies have performed: Similar approaches using topical emollients and gentle massage have produced mixed but sometimes favorable findings in smaller or non-randomized studies, so this post-market follow-up aims to add real-world data for this specific product.

Eligibility criteria

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.

Where this trial is running

Multiple Locations

• Multiples facilities — Multiple Locations, France (RECRUITING)

Study contacts

• Principal investigator: Sylvie MEAUME, PhD — Hôpital Rotschild
• Study coordinator: Renaud Urbinelli

Conditions: Pressure Ulcer Prevention, Effleurage, Pressure Ulcer, Topical Emollient, Post-Market Clinical Follow-Up, Rivadouce