Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers: Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Incidence of Pressure Ulcers on Treated Areas
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years at the time of inclusion.
- •At risk of developing pressure ulcers, as determined by clinical judgment and a Braden Scale score <
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of Pressure Ulcers on Treated Areas
时间窗: 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).
次要结局
- Time to Onset of First Pressure Ulcer on Treated Areas(Day 0 to Day 35 (±5 days))
- Occurrence of Adverse Events Related to the Device(Day 0 to Day 35 (±5 days))