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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-12

Study Completion Date

2025-04-10

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.

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Detailed Description

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Conditions

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Burns

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FibDex

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.

Group Type EXPERIMENTAL

FibDex

Intervention Type DEVICE

Nanofibrillar cellulose wound dressing

Epicite hydro

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

Group Type ACTIVE_COMPARATOR

Epicite hydro

Intervention Type DEVICE

Wound dressing

Epiprotect

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.

Group Type ACTIVE_COMPARATOR

Epiprotect

Intervention Type DEVICE

Wound dressing

Interventions

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FibDex

Nanofibrillar cellulose wound dressing

Intervention Type DEVICE

Epicite hydro

Wound dressing

Intervention Type DEVICE

Epiprotect

Wound dressing

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No