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

B. Braun Medical SA95 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Pressure Ulcer

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

Outcomes

Primary Outcomes

Safety of Linovera®

Number of patients with at least one Adverse Device Effect (ADE) or Severe Adverse Device Effect (SADE).

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

Secondary Outcomes

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.

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

A Visual Analogue Scale will be used, 0 representing "very poor" and 100 representing "excellent".

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

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".

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

Cumulative rates of each ADE/SADE that might appear until the Category-1 pressure ulcer/injury has healed and/or until patient discharge.

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

Central Contacts

Aina Fernández

CONTACT

+34 663 895 945 aina.fernandez@bbraun.com

Joan LLuís Perez

CONTACT

+34 670 528 799 joan_lluis.perez@bbraun.com

Data from ClinicalTrials.gov

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