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

UPM Biomedicals

Status: Terminated

Conditions: Burns

Treatments: Device: Epicite hydro; Device: Epiprotect; Device: FibDex

Study type: Interventional

Funder types: Industry

Identifiers

NCT05629091

Fibdex 1-2022

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 3 patient groups

FibDex

Experimental group

Description:

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.

Treatment:

Device: FibDex

Epicite hydro

Active Comparator group

Description:

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

Treatment:

Device: Epicite hydro

Epiprotect

Active Comparator group

Description:

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.

Treatment:

Device: Epiprotect