Observational Study of RIVADOUCE Vegetable Skincare Oil to Prevent Pressure Ulcers in At-Risk Adults

What this Trial Is About

Researchers are evaluating the clinical performance and safety of RIVADOUCE VEGETABLE SKINCARE OIL in preventing pressure ulcers in adults at risk. This observational post-market clinical follow-up study is conducted in real-life settings across multiple centers, focusing on patients with a Braden Scale score under 18 and no existing pressure ulcers. The study follows international standards and aims to gather updated evidence for device certification under EU regulations. The skincare oil is applied gently by effleurage to pressure-prone areas such as the sacrum, heels, ischial, and trochanteric regions as part of routine prevention protocols. A total of 252 adult patients will be enrolled and followed for 35 days, with a small allowance of 5 days variation. The study does not involve randomization or control groups, focusing on real-life product use and monitoring. Participants will be monitored for the development of pressure ulcers, timing of their onset, progression, and any adverse events potentially related to the device. Compliance with product use will also be tracked. The primary outcome is the proportion of patients developing at least one pressure ulcer of stage 1 or higher during the study period. Safety and performance data collected will help support ongoing product approval and clinical use.

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