Pressure Ulcer PreventionNCT07045480
Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers
An observational study of Pressure Ulcer Prevention, run by Laboratoires RIVADIS at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer Prevention
- How many people
- 252 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2025to 31 Jan 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult patients (≥18 years) who are at risk of developing pressure ulcers, as defined by clinical assessment and a Braden Scale score of less than 18. Eligible participants must have no existing pressure ulcers at baseline and be expected to remain in the participating healthcare facility (e.g., rehabilitation center, nursing home, or long-term care unit) for at least 35 ± 5 days. Patients will receive RIVADOUCE VEGETABLE SKINCARE OIL as part of routine pressure ulcer prevention care, applied by effleurage to pressure-prone skin areas. The study population is representative of frail, often immobilized individuals in geriatric or rehabilitative settings.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers: Observational Study
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.
Read more
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.
- Conditions
- Pressure Ulcer Prevention
- Keywords
- Effleurage, Pressure Ulcer, Topical Emollient, Post-Market Clinical Follow-Up, Rivadouce
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rivadouce Group | Patients aged 18 years and older, at risk of developing pressure ulcers (Braden Scale <18), without existing ulcers at baseline, and for whom RIVADOUCE VEGETABLE SKINCARE OIL is applied via effleurage as part of routine clinical practice. Patients are followed for 35 ± 5 days to monitor the incidence of pressure ulcers and adverse events. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Pressure Ulcers on Treated Areas
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).
Measured: Day 0 to Day 35 (±5 days)
Secondary outcomes (2)
Time to Onset of First Pressure Ulcer on Treated Areas
Number of days from baseline (Day 0) to first occurrence of a stage ≥1 pressure ulcer on a treated zone.
Measured: Day 0 to Day 35 (±5 days)
Occurrence of Adverse Events Related to the Device
Assessment of whether the oil was applied according to the protocol-defined frequency, zones, and method (effleurage).
Measured: Day 0 to Day 35 (±5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start4 Apr 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure Ulcer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratoires RIVADIS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sylvie MEAUME, PhD, Principal investigator, Hôpital Rotschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045480
- Sponsor's protocol ID
- 2024-A01643-44
- Status last verified
- Jun 2025
- First submitted
- 23 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Pressure Ulcers by Effleurage With RIVADOUCE VEGETABLE SKINCARE OIL in Patients at Risk of Pressure Ulcers: Observational Study
- ClinicalTrials.gov ID
- NCT07045480
- Acronym / sponsor ID
- 2024-A01643-44
- Conditions
- Pressure Ulcer Prevention
- Keywords
- Effleurage, Pressure Ulcer, Topical Emollient, Post-Market Clinical Follow-Up, Rivadouce
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Laboratoires RIVADISIndustry (pharma, biotech, devices)
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivadouce Group | – | –Patients aged 18 years and older, at risk of developing pressure ulcers (Braden Scale <18), without existing ulcers at baseline, and for whom RIVADOUCE VEGETABLE SKINCARE OIL is applied via effleurage as part of routine clinical practice. Patients are followed for 35 ± 5 days to monitor the incidence of pressure ulcers and adverse events. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult patients (≥18 years) who are at risk of developing pressure ulcers, as defined by clinical assessment and a Braden Scale score of less than 18. Eligible participants must have no existing pressure ulcers at baseline and be expected to remain in the participating healthcare facility (e.g., rehabilitation center, nursing home, or long-term care unit) for at least 35 ± 5 days. Patients will receive RIVADOUCE VEGETABLE SKINCARE OIL as part of routine pressure ulcer prevention care, applied by effleurage to pressure-prone skin areas. The study population is representative of frail, often immobilized individuals in geriatric or rehabilitative settings.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Pressure Ulcers on Treated Areas
Time frame: 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).
2 secondary outcomes
Time to Onset of First Pressure Ulcer on Treated Areas
Time frame: Day 0 to Day 35 (±5 days)
Occurrence of Adverse Events Related to the Device
Time frame: Day 0 to Day 35 (±5 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Enrolling by invitation
Effect of a Standardized Moisture-Care Protocol Using Skin Barrier Spray on Prevention of Pressure Injuries in the Perineal-Sacral Area Among Incontinent Inpatients: A 3-month Pilot Study.
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Evaluation of Commercially Available Heel Pads for the Prevention of Pressure Ulcers: An Observational Study of Incidence and Usability in Adult Surgical Patients.
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Sacrum Pressure Injury Prevention Study Using ALLEVYN◊ Complete Care in Adults at Risk of Developing Hospital-acquired Pressure Injuries in Critical Care Units
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sylvie MEAUME, PhD principal investigator
Hôpital Rotschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer Prevention, run by Laboratoires RIVADIS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renaud Urbinelli (+33658687286, etudes@clin-experts.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Pressure Ulcers on Treated Areas (time frame: Day 0 to Day 35 (±5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.