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

NCT05629091 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-08-15

No results posted yet for this study

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

  • Burns

Interventions

DEVICE

FibDex

Nanofibrillar cellulose wound dressing

DEVICE

Epicite hydro

Wound dressing

DEVICE

Epiprotect

Wound dressing

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • UPM-Kymmene Corporation

    lead INDUSTRY

Principal Investigators

  • Fredrik Huss · Burn Centre, Uppsala University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-12
Primary Completion
2025-04-10
Completion
2025-04-10

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629091 on ClinicalTrials.gov