BurnsNCT05629091

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

A study testing FibDex, Epicite hydro and Epiprotect in people with Burns, run by UPM-Kymmene Corporation at 1 site in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 1 year and older
Conditions the study is for: Burns
What is being tested?: FibDex, Epicite hydro and Epiprotect
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteSweden
Study dates: 12 Aug 2023to 10 Apr 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Signed written informed consent (by the patient and/or the patient's parent[s]/legal guardian[s] as applicable).
Patient with superficial dermal burn wound(s) (class II/A) ≤36h as assessed by the Investigator.
Patient at least 1 year old.
Patient who has at least 3 superficial dermal burn wounds on anatomically equivalent areas or a superficial dermal burn large enough to allow a lateral comparison.
Wound area at least 50 cm2 (per wound, if 3 separate wounds) or at least 150 cm2 (if single wound) as judged by the Investigator.

Who cannot join

Patient hyper-sensitive or allergic to, or have had a hypersensitivity/allergic reaction to, any of the dressing components.
Pregnant or breast-feeding female.
Patient with chemically or electrically induced burns.
Other non-burn wound in target wound area.
Not suitable for inclusion according to the Investigator.
Cognitive dysfunction or psychiatric history (Investigator's discretion).

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Chronic or presently active skin condition that is judged as interfering with normal wound healing process (Investigator's discretion)
Target burns on sensitive skin areas, such as the facial or genital area.
Inability or unwillingness of participant or parent(s)/legal guardian(s) to give written informed consent.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Burn Centre, Uppsala University Hospital
Uppsala

Other trials in Sweden

About this study

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

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
Being tested: FibDex, Epicite hydro, Epiprotect
Medical subject headings: Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FibDexDevice
Nanofibrillar cellulose wound dressing
Epicite hydroDevice
Wound dressing
EpiprotectDevice
Wound dressing

Study groups in NCT05629091
Study group	Role	What they receive
FibDex	Experimental	FibDex® is a CE-marked NFC wound dressing intended to come into contact with injured skin and specifically split-thickness skin graft wounds, which have breached the dermis. Receives: Device: FibDex
Epicite hydro	Active comparator	Epicitehydro is composed of biotechnology derived cellulose and is indicated for treatment of superficial and deep partial thermal and chemical burn wounds (1st and 2nd degree), scalds, skin graft donor sites, abrasions and lacerations Receives: Device: Epicite hydro
Epiprotect	Active comparator	Epiprotect is composed of biosynthetic cellulose. It contains a minimum of 95% isotonic saline solution. Epiprotect is intended for treatment of partial thickness wounds. It can also be used as a temporary coverage for full thickness wounds prior to transplantation or other surgical intervention. Receives: Device: Epiprotect

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
At each clinical visit, the Investigator or delegate will assess and record in the eCRF if the inner dressing(s) has detached and judge whether or not there is a need for outer dressing.
Measured: Within 2 to 3 weeks (until the wound has healed)

Secondary outcomes (10)

Non-inferiority of FibDex® compared to Epiprotect® in terms of time to clinical wound healing (days) defined as no need of any dressing (inner or outer).
At each clinical visit, the Investigator or delegate will assess and record in the eCRF if the inner dressing(s) has detached and judge whether or not there is a need for outer dressing.
Measured: Within 2 to 3 weeks (until the wound has healed)
Non-inferiority FibDex® compared to Epicitehydro and Epiprotect®, respectively, in terms of re-epithelialisation of the initial wound area over time
Percentage of re-epithelialisation will be evaluated by visual observation by the Investigator or delegate and classified according following categories: <50%, 50-75%, 76-90%, 90-95% and 96-100%.
Measured: Within 2 to 3 weeks (until the wound has healed)
Evaluate degree of experienced pain
On Day 1, pain will be measured before application of FibDex® and the comparators and after outer layer dressing application. On the subsequent visits, pain will be measured before (background pain) and after (procedural pain) outer layer dressing change during the wound healing period. Patients aged ≥8 years will rate subjective pain using a Numeric Pain Rating Scale (NPRS) 0-10 (0 representing no pain and 10 representing the worst possible pain). Patients aged 4 to 7 years will rate pain using The Faces Pain Scale 0-10 (0 representing no pain and 10 representing very much pain). The Faces, Legs, Activity, Cry, Consolability (FLACC) 0-10 (0 is relaxed and comfortable and 7-10 is severe pain or discomfort or both) behavioural measurement will be used for assessment of pain in patients aged ≤3 years.
Measured: Within 2 to 3 weeks (until the wound has healed)
Assess clinical performance in terms of number of wound infections
The burn will be diagnosed with wound infection if at least 2 of the criteria based on the definition of burn wound infection stated by the American Burn Association, are fulfilled.
Measured: Within 2 to 3 weeks (until the wound has healed)
Need for surgical intervention
If wounds, during subsequent dressing changes and assessments, is judged as not progressing in a favourable direction, or if time from trauma approaches/exceeds 2 to 3 weeks, surgical intervention should be considered.
Measured: Within 2 to 3 weeks (until the wound has healed)
Assess clinical performance in terms of length of stay (days) at hospital
All patients hospitalised for their burns will be monitored by a research nurse. The day of discharge will be recorded in the eCRF. Any readmission after the initial discharge will also be noted in the eCRF and included in the total length of stay.
Measured: Within 2 to 3 weeks (until the wound has healed)
Assess clinical performance in terms of number of outer layer dressing changes
Outer dressings will be changed at each visit (from Visit 3 and onwards) if deemed appropriate by the Investigator
Measured: Within 2 to 3 weeks (until the wound has healed)
Evaluate scar quality
Burn scar outcome will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS). For both the patient and the observer, the score for each item is added (1 - 10 where 10 indicates the worst imaginable sensation or scar and 1 corresponds to normal skin. Moreover, observer scale nominal variables, such as type of pigmentation, may be recorded in category boxes in addition to the 10 point scale. Lastly, the patient and observer score their "Overall Opinion" of the scar compared to normal skin with the same 10 point scale, where 1 is normal skin and 10 is the most markedly different scar.
Measured: 3, 6 and 12 months post burn
Monitor Adverse Events (AEs)
Frequency, intensity and seriousness of AEs
Measured: Within 2 to 3 weeks (until the wound has healed)
Monitor Device Deficiencies (DDs)
Frequency and nature of DDs
Measured: Within 2 to 3 weeks (until the wound has healed)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Aug 202310 Apr 2025

First posted29 Nov 2022
Study start12 Aug 2023
Primary completion10 Apr 2025
Study completion10 Apr 2025

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for BurnsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05629091
Sponsor's protocol ID: Fibdex 1-2022
Status last verified: Aug 2025
First submitted: 12 Oct 2022
Last updated: 15 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Burns trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05629091
Acronym / sponsor ID: Fibdex 1-2022
Conditions: Burns
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 7 participants (actual)
Lead sponsor: UPM-Kymmene CorporationIndustry (pharma, biotech, devices)
Collaborators: CTC Clinical Trial Consultants AB
Study start: 12 Aug 2023 (actual)
Primary completion: 10 Apr 2025 (actual)
Study completion: 10 Apr 2025 (actual)
First posted: 29 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
FibDex	Experimental	Device: FibDexFibDex® is a CE-marked NFC wound dressing intended to come into contact with injured skin and specifically split-thickness skin graft wounds, which have breached the dermis.
Epicite hydro	Active comparator	Device: Epicite hydroEpicitehydro is composed of biotechnology derived cellulose and is indicated for treatment of superficial and deep partial thermal and chemical burn wounds (1st and 2nd degree), scalds, skin graft donor sites, abrasions and lacerations
Epiprotect	Active comparator	Device: EpiprotectEpiprotect is composed of biosynthetic cellulose. It contains a minimum of 95% isotonic saline solution. Epiprotect is intended for treatment of partial thickness wounds. It can also be used as a temporary coverage for full thickness wounds prior to transplantation or other surgical intervention.

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Signed written informed consent (by the patient and/or the patient's parent[s]/legal guardian[s] as applicable).
Patient with superficial dermal burn wound(s) (class II/A) ≤36h as assessed by the Investigator.
Patient at least 1 year old.
Patient who has at least 3 superficial dermal burn wounds on anatomically equivalent areas or a superficial dermal burn large enough to allow a lateral comparison.
Wound area at least 50 cm2 (per wound, if 3 separate wounds) or at least 150 cm2 (if single wound) as judged by the Investigator.

Key exclusion criteria (9 listed)

Patient hyper-sensitive or allergic to, or have had a hypersensitivity/allergic reaction to, any of the dressing components.
Pregnant or breast-feeding female.
Patient with chemically or electrically induced burns.
Other non-burn wound in target wound area.
Not suitable for inclusion according to the Investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FibDexNanofibrillar cellulose wound dressing	Device	FibDex
Epicite hydroWound dressing	Device	Epicite hydro
EpiprotectWound dressing	Device	Epiprotect

Primary outcome

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)
Time frame: Within 2 to 3 weeks (until the wound has healed)
At each clinical visit, the Investigator or delegate will assess and record in the eCRF if the inner dressing(s) has detached and judge whether or not there is a need for outer dressing.

10 secondary outcomes

Non-inferiority of FibDex® compared to Epiprotect® in terms of time to clinical wound healing (days) defined as no need of any dressing (inner or outer).
Time frame: Within 2 to 3 weeks (until the wound has healed)
Non-inferiority FibDex® compared to Epicitehydro and Epiprotect®, respectively, in terms of re-epithelialisation of the initial wound area over time
Time frame: Within 2 to 3 weeks (until the wound has healed)
Evaluate degree of experienced pain
Time frame: Within 2 to 3 weeks (until the wound has healed)
Assess clinical performance in terms of number of wound infections
Time frame: Within 2 to 3 weeks (until the wound has healed)
Need for surgical intervention
Time frame: Within 2 to 3 weeks (until the wound has healed)
Assess clinical performance in terms of length of stay (days) at hospital
Time frame: Within 2 to 3 weeks (until the wound has healed)
Assess clinical performance in terms of number of outer layer dressing changes
Time frame: Within 2 to 3 weeks (until the wound has healed)
Evaluate scar quality
Time frame: 3, 6 and 12 months post burn
Monitor Adverse Events (AEs)
Time frame: Within 2 to 3 weeks (until the wound has healed)
Monitor Device Deficiencies (DDs)
Time frame: Within 2 to 3 weeks (until the wound has healed)

Results and safety

The study was stopped early (reason given: 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.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.

Related trials for Burns

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Not yet recruitingObservational study
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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fredrik Huss principal investigator

Burn Centre, Uppsala University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing FibDex, Epicite hydro and Epiprotect in people with Burns, run by UPM-Kymmene Corporation at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Within 2 to 3 weeks (until the wound has healed)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05629091.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.