PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries (TRELINOIL)

B. Braun

Status: Enrolling

Conditions: Pressure Ulcer

Treatments: Device: Linovera®

Study type: Observational

Funder types: Industry

Identifiers

NCT06183086

BA-O-H-23029

Details and patient eligibility

About

To assess the safety and performance of Linovera® in the treatment of Category- I pressure ulcers/injuries.

Full 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.

Enrollment: 95 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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 design

95 participants in 1 patient group

Linovera

Description:

Apply Linovera under clinical routine practice

Treatment:

Device: Linovera®