Clinical trial NCT05629091: An Investigation of Performance and Safety of the Wound Dressing FibDex in Patients With Superficial Dermal Burns
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Burns
Lead sponsor: UPM Biomedicals
Sponsor class: INDUSTRY
Collaborators: name: CTC Clinical Trial Consultants AB
First posted: 2022-11-29
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: Within 2 to 3 weeks (until the wound has healed)
Secondary outcomes:
measure: 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).
timeFrame: Within 2 to 3 weeks (until the wound has healed)
measure: Non-inferiority FibDex® compared to Epicitehydro and Epiprotect®, respectively, in terms of re-epithelialisation of the initial wound area over time
timeFrame: Within 2 to 3 weeks (until the wound has healed)
measure: Evaluate degree of experienced pain
timeFrame: Within 2 to 3 weeks (until the wound has healed)
measure: Assess clinical performance in terms of number of wound infections
timeFrame: Within 2 to 3 weeks (until the wound has healed)
measure: Need for surgical intervention
timeFrame: Within 2 to 3 weeks (until the wound has healed)
measure: Assess clinical performance in terms of length of stay (days) at hospital
timeFrame: Within 2 to 3 weeks (until the wound has healed)
measure: Assess clinical performance in terms of number of outer layer dressing changes
timeFrame: Within 2 to 3 weeks (until the wound has healed)
measure: Evaluate scar quality
timeFrame: 3, 6 and 12 months post burn
measure: Monitor Adverse Events (AEs)
timeFrame: Within 2 to 3 weeks (until the wound has healed)
measure: Monitor Device Deficiencies (DDs)
timeFrame: Within 2 to 3 weeks (until the wound has healed)
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Burn Centre, Uppsala University Hospital
Study officials:
affiliation: Burn Centre, Uppsala University Hospital
name: Fredrik Huss
role: PRINCIPAL_INVESTIGATOR
References: