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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linovera | Apply Linovera under clinical routine practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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See eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aina Fernández | Contact | +34 663 895 945 | aina.fernandez@bbraun.com | |
| Joan LLuís Perez | Contact | +34 670 528 799 | joan_lluis.perez@bbraun.com |
| Name | Affiliation | Role |
|---|---|---|
| Susana Valerdiz | Hospital Universitario Central de Asturias | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Central de Asturias | Recruiting | Oviedo | Spain |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 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 |
| 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 |
| 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 |