NCT06183086

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 95 (estimated)
• Sponsor: B. Braun Medical SA · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pressure Ulcer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-14
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2023-12-27
• Last updated: 2023-12-27

Locations

1 site across 1 country: Spain