Trials / Terminated
TerminatedNCT05629091
An Investigation of Performance and Safety of the Wound Dressing FibDex in Patients With Superficial Dermal Burns
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
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 7 (actual)
- Sponsor
- UPM-Kymmene Corporation · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FibDex | Nanofibrillar cellulose wound dressing |
| DEVICE | Epicite hydro | Wound dressing |
| DEVICE | Epiprotect | Wound dressing |
Timeline
- Start date
- 2023-08-12
- Primary completion
- 2025-04-10
- Completion
- 2025-04-10
- First posted
- 2022-11-29
- Last updated
- 2025-08-15
Locations
1 site across 1 country: Sweden
Source: ClinicalTrials.gov record NCT05629091. Inclusion in this directory is not an endorsement.