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

Recruitingn/aAges 18 Years - anyAllLaboratoires RIVADIS
NCT07045480 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 classif

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

1 site
Multiples facilities
Multiple Locations, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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