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

Pressure Ulcer Clinical Trial

— TRELINOIL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06183086
• Other study ID #: BA-O-H-23029
• Status: Recruiting
• Start date: November 14, 2023
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: B. Braun Medical SA
• Contact: Aina Fernández
• Phone: +34 663 895 945
• Email: aina.fernandez[@]bbraun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pressure Ulcer
• Ulcer

Intervention

Device:
• Linovera®
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Central de Asturias	Oviedo

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Medical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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