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

Recruiting

• Conditions: Pressure Ulcer
• Interventions: Device: Linovera®

• Registration Number: NCT06183086
• Lead Sponsor: B. Braun Medical SA

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 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 Timeline

• Study First Submitted: 2023-10-19
• Study Start: 2023-11-14
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-27
• Last Update Posted: 2023-12-27
• Primary Completion: 2024-11
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 95

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Linovera	Linovera®	Apply Linovera under clinical routine practice

Primary Outcome Measures

Name	Time	Method
Safety of Linovera®	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	Number of patients with at least one Adverse Device Effect (ADE) or Severe Adverse Device Effect (SADE).

Secondary Outcome Measures

Name	Time	Method
Healing of the Category-1 pressure ulcer/injury	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	Healing will be evaluated according to routine clinical practices with the following scale: Healed, no variation and worsening.
Ease of use of the device	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	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".
Cumulative rates of each ADE/SADE	From the start of the study until Category-1 pressure ulcer/injury healed or patient discharge, whichever came first, assessed up to 30 days	Cumulative rates of each ADE/SADE that might appear until the Category-1 pressure ulcer/injury has healed and/or until patient discharge.
Patient and intended user satisfaction	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	A Visual Analogue Scale will be used, 0 representing "very poor" and 100 representing "excellent".

Trial Locations

Locations (1)

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain