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

NCT05629091 | Terminated

• 1 other identifier: Fibdex 1-2022
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

  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

  Within 2 to 3 weeks (until the wound has healed)

• Evaluate degree of experienced pain

  Within 2 to 3 weeks (until the wound has healed)

• Assess clinical performance in terms of number of wound infections

  Within 2 to 3 weeks (until the wound has healed)

• Need for surgical intervention

  Within 2 to 3 weeks (until the wound has healed)

Study Arms (3)

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.

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

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.

Device: Epiprotect

Interventions

FibDex DEVICE

Nanofibrillar cellulose wound dressing

FibDex

Epicite hydro DEVICE

Wound dressing

Epicite hydro

Epiprotect DEVICE

Wound dressing

Epiprotect

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Cognitive dysfunction or psychiatric history (Investigator's discretion).
• 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.

Sponsors & Collaborators

• UPM-Kymmene Corporation: lead
• CTC Clinical Trial Consultants AB: collaborator

Study Sites (1)

Burn Centre, Uppsala University Hospital

Uppsala, Sweden

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Fredrik Huss

  Burn Centre, Uppsala University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: November 29, 2022
• Study Start: August 12, 2023
• Primary Completion: April 10, 2025
• Study Completion: April 10, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

SE (1)