Pressure Ulcer
Conditions
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.
Interventions
DEVICELinovera®
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.
Sponsors
B. Braun Medical SA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
Spain
Contacts
Primary ContactAina Fernández
Backup ContactJoan LLuís Perez
Outcome results
None listed