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NCT07045480
Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers
trial in Pressure Ulcer Prevention in 252 participants. Currently enrolling.
31 January 2026
Quick facts
| Lead sponsor | Laboratoires RIVADIS |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 252 |
| Start date | 4 April 2025 |
| Primary completion | 31 January 2026 |
| Estimated completion | 31 January 2026 |
| Sites | 1 location across France |
Conditions studied
- Pressure Ulcer Prevention — all drugs for Pressure Ulcer Prevention →
Sponsor
Laboratoires RIVADIS
Who can join
18 and older, any sex, with Pressure Ulcer Prevention. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07045480
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Pressure Ulcer Prevention
Currently open trials in the same condition.
- NCT06758674 — The Effect of an Training Program for the Prevention of Pressure Ulcers in Bedridden Patients At Home · NA · active not recruiting
- NCT06790277 — Polyurethane Foam-Pink Pad (RCT) Use in OR · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07045480 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Laboratoires RIVADIS
- Last refreshed: 1 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07045480.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing