PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries
NCT ID: NCT06183086
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
95 participants
OBSERVATIONAL
2023-11-14
2024-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Linovera
Apply Linovera under clinical routine practice
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
100 Years
ALL
No
Sponsors
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B. Braun Medical SA
INDUSTRY
Responsible Party
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Principal Investigators
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Susana Valerdiz
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Central de Asturias
Locations
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Hospital Universitario Central de Asturias
Oviedo, , Spain
Countries
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Central Contacts
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Facility Contacts
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Susana Valerdiz
Role: primary
Other Identifiers
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BA-O-H-23029
Identifier Type: -
Identifier Source: org_study_id