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

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.

Inclusion Criteria:

1. Signed written informed consent (by the patient and/or the patient's parent[s]/legal guardian[s] as applicable).
2. Patient with superficial dermal burn wound(s) (class II/A) ≤36h as assessed by the Investigator.
3. Patient at least 1 year old.
4. 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.
5. 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.

Exclusion Criteria:

1. Patient hyper-sensitive or allergic to, or have had a hypersensitivity/allergic reaction 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 normal wound 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 give written informed consent.