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An Investigation of Performance and Safety of the Wound Dressing FibDex in Patients With Superficial Dermal Burns

Burns Clinical Trial

Official title:
A Randomised, Open-label Clinical Investigation of Clinical Performance and Safety of the Nanofibrillar Cellulose Wound Dressing FibDex in Paediatric and Adult Patients With Superficial Dermal Burns

Clinical Trial Summary

This is a prospective, randomised, open-label, within-patient controlled, non-inferiority clinical investigation of the nanofibrillar cellulose (NFC) wound dressing FibDex® for treatment of superficial dermal burns in paediatric and adult patients. The clinical performance and safety of FibDex® will be compared to Epicitehydro (QRSKIN GmbH, Würzburg, Germany) and Epiprotect® (S2Medical AB, Linköping, Sweden). Epicitehydro is considered to be the primary comparator. The investigation will be conducted at 2 clinical research sites in Sweden.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05629091
Study type Interventional
Source UPM Biomedicals
Contact Johana Kuncova-Kallio
Phone +35820415111
Email johana.kuncova-kallio@upm.com
Status Recruiting
Phase N/A
Start date August 12, 2023
Completion date August 30, 2024
View Details
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