Preventing pressure ulcers with gentle application of Rivadouce vegetable skincare oil

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Multiples facilities
  Multiple Locations, France Recruiting

Study contacts

• Principal investigator: Sylvie MEAUME, PhD — Hôpital Rotschild
• Study coordinator: Renaud Urbinelli
• Email: etudes@clin-experts.fr
• Phone: +33658687286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.