Clinical trial NCT06183086: PMCF Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries
Official title: Prospective, Multicentre, Single-arm, Controlled Study on the Safety of Linovera® for the Treatment of Category-I Pressure Ulcers/Injuries
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pressure Ulcer
Lead sponsor: B. Braun Medical SA
Sponsor class: INDUSTRY
First posted: 2023-12-27
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: See eligibility criteria

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety of Linovera®
timeFrame: 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:
measure: Healing of the Category-1 pressure ulcer/injury
timeFrame: 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
measure: Patient and intended user satisfaction
timeFrame: 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
measure: Ease of use of the device
timeFrame: 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
measure: Cumulative rates of each ADE/SADE
timeFrame: From the start of the study until Category-1 pressure ulcer/injury healed or patient discharge, whichever came first, assessed up to 30 days
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
Study officials:
affiliation: Hospital Universitario Central de Asturias
name: Susana Valerdiz
role: PRINCIPAL_INVESTIGATOR
References: