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Clinical Trials/NCT05629091
NCT05629091TerminatedNot Applicable

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

UPM Biomedicals1 site in 1 country7 target enrollmentStarted: August 12, 2023Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
7
Locations
1
Primary Endpoint
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)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
1 Year to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

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)

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

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.

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).(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(Within 2 to 3 weeks (until the wound has healed))
  • Evaluate degree of experienced pain(Within 2 to 3 weeks (until the wound has healed))
  • Assess clinical performance in terms of number of outer layer dressing changes(Within 2 to 3 weeks (until the wound has healed))
  • Assess clinical performance in terms of number of wound infections(Within 2 to 3 weeks (until the wound has healed))
  • Need for surgical intervention(Within 2 to 3 weeks (until the wound has healed))
  • Assess clinical performance in terms of length of stay (days) at hospital(Within 2 to 3 weeks (until the wound has healed))
  • Evaluate scar quality(3, 6 and 12 months post burn)
  • Monitor Adverse Events (AEs)(Within 2 to 3 weeks (until the wound has healed))
  • Monitor Device Deficiencies (DDs)(Within 2 to 3 weeks (until the wound has healed))

Investigators

Sponsor
UPM Biomedicals
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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