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

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NCT05629091

Sponsored by UPM-Kymmene Corporation (industry) · UPM.HE — their whole pipeline →. With CTC Clinical Trial Consultants AB.

Phase
Not applicable
Status
Terminated
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
7actual
Sites
1
Country
Sweden

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Why the sponsor stopped it

UPM Kymmene Oyj announced on April 2, 2025, the closure of Biomedicals business. As a result, FibDex manufacturing and sales will discontinue. The premature termination is due to business decision, not related to any safety concerns of FibDex.

As filed on the registry record, in the sponsor's own words.

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2023-08-12actualWhen the study began enrolling
Primary completion2025-04-10actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2025-04-10actualThe whole study's end, after follow-up
First posted2022-11-29actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2025-08-15actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Burns

Interventions

  • Device: FibDex
  • Device: Epicite hydro
  • Device: Epiprotect

Primary outcome

what the primary-completion date above is the date OF
Non-inferiority of FibDex® compared to Epicitehydro in terms of time to clinical wound healing (days) defined as no need of any dressing (inner or outer)
measured Within 2 to 3 weeks (until the wound has healed)

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