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

Last updated: March 14, 2025
Sponsor: UPM Biomedicals
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Skin Wounds

Hyponatremia

Treatment

FibDex

Epiprotect

Epicite hydro

Clinical Study ID

NCT05629091
Fibdex 1-2022
  • Ages > 1
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Signed written informed consent (by the patient and/or the patient's parent[s]/legalguardian[s] as applicable).

  2. Patient with superficial dermal burn wound(s) (class II/A) ≤36h as assessed by theInvestigator.

  3. Patient at least 1 year old.

  4. Patient who has at least 3 superficial dermal burn wounds on anatomically equivalentareas or a superficial dermal burn large enough to allow a lateral comparison.

  5. Wound area at least 50 cm2 (per wound, if 3 separate wounds) or at least 150 cm2 (ifsingle wound) as judged by the Investigator.

Exclusion

Exclusion Criteria:

  1. Patient hyper-sensitive or allergic to, or have had a hypersensitivity/allergicreaction to, any of the dressing components.

  2. Pregnant or breast-feeding female.

  3. Patient with chemically or electrically induced burns.

  4. Other non-burn wound in target wound area.

  5. Not suitable for inclusion according to the Investigator.

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

  7. Chronic or presently active skin condition that is judged as interfering with normalwound healing process (Investigator's discretion)

  8. Target burns on sensitive skin areas, such as the facial or genital area.

  9. Inability or unwillingness of participant or parent(s)/legal guardian(s) to givewritten informed consent.

Study Design

Total Participants: 30
Treatment Group(s): 3
Primary Treatment: FibDex
Phase:
Study Start date:
August 12, 2023
Estimated Completion Date:
August 30, 2026

Connect with a study center

  • Burn Centre, Uppsala University Hospital

    Uppsala,
    Sweden

    Site Not Available

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