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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Burns

Intervention / Treatment
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* Device: FibDex
* Device: Epicite hydro
* Device: Epiprotect


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written informed consent (by the patient and/or the patient's parent[s]/legal guardian[s] as applicable). Patient with superficial dermal burn wound(s) (class II/A) ≤36h as assessed by the Investigator. Patient at least 1 year old. 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. 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: Patient hyper-sensitive or allergic to, or have had a hypersensitivity/allergic reaction to, any of the dressing components. Pregnant or breast-feeding female. Patient with chemically or electrically induced burns. Other non-burn wound in target wound area. Not suitable for inclusion according to the Investigator. Cognitive dysfunction or psychiatric history (Investigator's discretion). Chronic or presently active skin condition that is judged as interfering with normal wound healing process (Investigator's discretion) Target burns on sensitive skin areas, such as the facial or genital area. Inability or unwillingness of participant or parent(s)/legal guardian(s) to give written informed consent.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FibDex<br>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. | Device: FibDex<br>* Nanofibrillar cellulose wound dressing<br>|
| Active Comparator: Epicite hydro<br>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 | Device: Epicite hydro<br>* Wound dressing<br>|
| Active Comparator: Epiprotect<br>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. | Device: Epiprotect<br>* Wound dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 2 to 3 weeks (until the wound has healed) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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%. | 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. | Within 2 to 3 weeks (until the wound has healed) | 
| Assess clinical performance in terms of number of wound infections | The burn will be diagnosed with wound infection if at least 2 of the criteria based on the definition of burn wound infection stated by the American Burn Association, are fulfilled. | Within 2 to 3 weeks (until the wound has healed) | 
| Need for surgical intervention | If wounds, during subsequent dressing changes and assessments, is judged as not progressing in a favourable direction, or if time from trauma approaches/exceeds 2 to 3 weeks, surgical intervention should be considered. | Within 2 to 3 weeks (until the wound has healed) | 
| Assess clinical performance in terms of length of stay (days) at hospital | All patients hospitalised for their burns will be monitored by a research nurse. The day of discharge will be recorded in the eCRF. Any readmission after the initial discharge will also be noted in the eCRF and included in the total length of stay. | Within 2 to 3 weeks (until the wound has healed) | 
| Assess clinical performance in terms of number of outer layer dressing changes | Outer dressings will be changed at each visit (from Visit 3 and onwards) if deemed appropriate by the Investigator | Within 2 to 3 weeks (until the wound has healed) | 
| Evaluate scar quality | Burn scar outcome will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS). For both the patient and the observer, the score for each item is added (1 - 10 where 10 indicates the worst imaginable sensation or scar and 1 corresponds to normal skin. Moreover, observer scale nominal variables, such as type of pigmentation, may be recorded in category boxes in addition to the 10 point scale. Lastly, the patient and observer score their Overall Opinion of the scar compared to normal skin with the same 10 point scale, where 1 is normal skin and 10 is the most markedly different scar. | 3, 6 and 12 months post burn | 
| Monitor Adverse Events (AEs) | Frequency, intensity and seriousness of AEs | Within 2 to 3 weeks (until the wound has healed) | 
| Monitor Device Deficiencies (DDs) | Frequency and nature of DDs | Within 2 to 3 weeks (until the wound has healed) |