Pressure UlcerTRELINOILNCT06183086
PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries
An observational study of Pressure Ulcer, run by B. Braun Medical SA at 1 site in Spain.
Trial summary
To assess the safety and performance of Linovera® in the treatment of Category- I pressure ulcers/injuries. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Linovera®
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 1 siteSpain
- Study dates
- 14 Nov 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: See eligibility criteria
Who may be able to join
- Adult patient (≥ 18 years)
- Patients with at least one Category-I PU/I (remark: follow-up will be done for one ulcer per patient).
- Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the EC prior to all evaluations.
- Patient naïve to Linovera® 2 weeks before visit 1 (only applicable to the area of the skin that will be assessed).
- Patients which can be potentially followed until their Category-1 pressure ulcer/injury is healed throughout the duration of the study, according to the clinicians opinion.
Who cannot join
- Age <18 years
- Known allergies and/or hypersensitivity to any component of Linovera®.
- Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures.
- Any planned intervention that, in the investigator opinion, may affect skin condition of the patient (e.g. chemotherapy or radiotherapy).
- Simultaneous participation in an interventional clinical trial (drugs or medical devices studies).
- Any other additional topical treatments applied in the area of the skin that will be assessed.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Central de Asturias
Oviedo
Susana Valerdiz
About this study
Official title: Prospective, Multicentre, Single-arm, Controlled Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries
To assess the safety and performance of Linovera® in the treatment of Category- I pressure ulcers/injuries.
Read the detailed description
The aim of this clinical study is to generate further clinical evidence for the use and benefit of Linovera® in the treatment of Category-I PUs. The results of this study will generate further clinical evidence for the use and the benefit of Linovera® in this indication.
Furthermore, the proactive collection of clinical data for Linovera® will support the maintenance of this skin oil on the market, so that in the future other patients can receive the product for the treatment of Category-I PUs.
- Conditions
- Pressure Ulcer
- Being tested
- Linovera®
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linovera®Device
Apply Linovera® at least twice a day (recommended every 12 h) on the pressure ulcer/injury until Category-1 pressure ulcer/injury is healed or until discharge.
| Study group | Role | What they receive |
|---|---|---|
| Linovera | Apply Linovera under clinical routine practice Receives: Device: Linovera® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Linovera®
Number of patients with at least one Adverse Device Effect (ADE) or Severe Adverse Device Effect (SADE).
Measured: From the date of start of study until Category-1 pressure ulcer/injury heals or patient discharge, whichever came first, assessed up to 30 days
Secondary outcomes (4)
Healing of the Category-1 pressure ulcer/injury
Healing will be evaluated according to routine clinical practices with the following scale: Healed, no variation and worsening.
Measured: From the start of the study until the first 72 hours and when the Category-1 pressure ulcer/injury healed and/or at patient discharge
Patient and intended user satisfaction
A Visual Analogue Scale will be used, 0 representing "very poor" and 100 representing "excellent".
Measured: From the start of the study until the first 72 hours and when the Category-1 pressure ulcer/injury healed and/or at patient discharge
Ease of use of the device
The following paramenters will be evaluated by the patient and/or by the healthcare professional: ease of spreading surfaces, needed dose of oil dispensed, ease of application in large surfaces, absorption of Linovera®. This handling parameters will be rated as "very easy", "easy", "diffucult" or "very difficult".
Measured: From the start of the study until Category-1 pressure ulcer/injury healed and/or at patient discharge, whichever came first, assessed up to 30 days
Cumulative rates of each ADE/SADE
Cumulative rates of each ADE/SADE that might appear until the Category-1 pressure ulcer/injury has healed and/or until patient discharge.
Measured: From the start of the study until Category-1 pressure ulcer/injury healed or patient discharge, whichever came first, assessed up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start14 Nov 2023
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies 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
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B. Braun Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Susana Valerdiz, Principal investigator, Hospital Universitario Central de Asturias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183086
- Sponsor's protocol ID
- BA-O-H-23029
- Acronym
- TRELINOIL
- Status last verified
- Dec 2023
- First submitted
- 19 Oct 2023
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, Single-arm, Controlled Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries
- ClinicalTrials.gov ID
- NCT06183086
- Acronym / sponsor ID
- TRELINOIL / BA-O-H-23029
- Conditions
- Pressure Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- B. Braun Medical SAIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Dec 2023 (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.
To assess the safety and performance of Linovera® in the treatment of Category- I pressure ulcers/injuries.
Detailed description
The aim of this clinical study is to generate further clinical evidence for the use and benefit of Linovera® in the treatment of Category-I PUs. The results of this study will generate further clinical evidence for the use and the benefit of Linovera® in this indication.
Furthermore, the proactive collection of clinical data for Linovera® will support the maintenance of this skin oil on the market, so that in the future other patients can receive the product for the treatment of Category-I PUs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linovera | – | Device: Linovera®Apply Linovera under clinical routine practice |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See eligibility criteria
Key inclusion criteria (5 listed)
- Adult patient (≥ 18 years)
- Patients with at least one Category-I PU/I (remark: follow-up will be done for one ulcer per patient).
- Provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the EC prior to all evaluations.
- Patient naïve to Linovera® 2 weeks before visit 1 (only applicable to the area of the skin that will be assessed).
- Patients which can be potentially followed until their Category-1 pressure ulcer/injury is healed throughout the duration of the study, according to the clinicians opinion.
Key exclusion criteria (6 listed)
- Age <18 years
- Known allergies and/or hypersensitivity to any component of Linovera®.
- Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures.
- Any planned intervention that, in the investigator opinion, may affect skin condition of the patient (e.g. chemotherapy or radiotherapy).
- Simultaneous participation in an interventional clinical trial (drugs or medical devices studies).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linovera®Apply Linovera® at least twice a day (recommended every 12 h) on the pressure ulcer/injury until Category-1 pressure ulcer/injury is healed or until discharge. | Device | Linovera |
Primary outcome
Safety of Linovera®
Time frame: From the date of start of study until Category-1 pressure ulcer/injury heals or patient discharge, whichever came first, assessed up to 30 days
Number of patients with at least one Adverse Device Effect (ADE) or Severe Adverse Device Effect (SADE).
4 secondary outcomes
Healing of the Category-1 pressure ulcer/injury
Time frame: From the start of the study until the first 72 hours and when the Category-1 pressure ulcer/injury healed and/or at patient discharge
Patient and intended user satisfaction
Time frame: From the start of the study until the first 72 hours and when the Category-1 pressure ulcer/injury healed and/or at patient discharge
Ease of use of the device
Time frame: From the start of the study until Category-1 pressure ulcer/injury healed and/or at patient discharge, whichever came first, assessed up to 30 days
Cumulative rates of each ADE/SADE
Time frame: From the start of the study until Category-1 pressure ulcer/injury healed or patient discharge, whichever came first, assessed up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Susana Valerdiz principal investigator
Hospital Universitario Central de Asturias
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, run by B. Braun Medical SA at 1 site in Spain.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aina Fernández (+34 663 895 945, aina.fernandez@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Linovera® (time frame: From the date of start of study until Category-1 pressure ulcer/injury heals or patient discharge, whichever came first, assessed up to 30 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 27 Dec 2023.