Status:
UNKNOWN
PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries
Lead Sponsor:
B. Braun Medical SA
Conditions:
Pressure Ulcer
Eligibility:
All Genders
18-100 years
Brief Summary
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 clinica...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT06183086
Start Date
November 14 2023
End Date
December 1 2024
Last Update
December 27 2023
Active Locations (1)
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1
Hospital Universitario Central de Asturias
Oviedo, Spain