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

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

Detailed Description
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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.

Official Title
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Prospective, Multicentre, Single-arm, Controlled Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries

Conditions
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Pressure Ulcer

Intervention / Treatment
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* Device: Linovera®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Linovera<br>Apply Linovera under clinical routine practice | Device: Linovera®<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Linovera® | Number of patients with at least one Adverse Device Effect (ADE) or Severe Adverse Device Effect (SADE). | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | From the start of the study until Category-1 pressure ulcer/injury healed or patient discharge, whichever came first, assessed up to 30 days |