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

UPM-Kymmene Corporation7 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burns

Interventions

FibDexDEVICE

Nanofibrillar cellulose wound dressing

Epicite hydroDEVICE

Wound dressing

EpiprotectDEVICE

Wound dressing

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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.

Locations (1)

Burn Centre, Uppsala University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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).

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.

Time frame: 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

Percentage of re-epithelialisation will be evaluated by visual observation by the Investigator or delegate and classified according following categories: \<50%, 50-75%, 76-90%, 90-95% and 96-100%.

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

Evaluate degree of experienced pain

On Day 1, pain will be measured before application of FibDex® and the comparators and after outer layer dressing application. On the subsequent visits, pain will be measured before (background pain) and after (procedural pain) outer layer dressing change during the wound healing period. Patients aged ≥8 years will rate subjective pain using a Numeric Pain Rating Scale (NPRS) 0-10 (0 representing no pain and 10 representing the worst possible pain). Patients aged 4 to 7 years will rate pain using The Faces Pain Scale 0-10 (0 representing no pain and 10 representing very much pain). The Faces, Legs, Activity, Cry, Consolability (FLACC) 0-10 (0 is relaxed and comfortable and 7-10 is severe pain or discomfort or both) behavioural measurement will be used for assessment of pain in patients aged ≤3 years.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.