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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

FibDex

Epicite hydro

Epiprotect

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Burn Centre, Uppsala University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

FibDex

Epicite hydro

Epiprotect

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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%.

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.

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.

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.

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.

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

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.

Monitor Adverse Events (AEs)

Frequency, intensity and seriousness of AEs

Monitor Device Deficiencies (DDs)

Frequency and nature of DDs

Full Information

NCT ID

NCT05629091

First Posted

October 12, 2022

Last Updated

October 6, 2023

Sponsor

UPM Biomedicals

Collaborators

CTC Clinical Trial Consultants AB

1. Study Identification

Unique Protocol Identification Number

NCT05629091

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 12, 2023 (Actual)

Primary Completion Date

August 30, 2024 (Anticipated)

Study Completion Date

August 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UPM Biomedicals

Collaborators

CTC Clinical Trial Consultants AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burns

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FibDex

Arm Type

Experimental

Arm Description

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.

Arm Title

Epicite hydro

Arm Type

Active Comparator

Arm Description

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

Arm Title

Epiprotect

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

FibDex

Intervention Description

Nanofibrillar cellulose wound dressing

Intervention Type

Device

Intervention Name(s)

Epicite hydro

Intervention Description

Wound dressing

Intervention Type

Device

Intervention Name(s)

Epiprotect

Intervention Description

Wound dressing

Primary Outcome Measure Information:

Title

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)

Description

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 Outcome Measure Information:

Title

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).

Description

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)

Title

Non-inferiority FibDex® compared to Epicitehydro and Epiprotect®, respectively, in terms of re-epithelialisation of the initial wound area over time

Description

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)

Title

Evaluate degree of experienced pain

Description

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.

Time Frame

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

Title

Assess clinical performance in terms of number of wound infections

Description

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.

Time Frame

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

Title

Need for surgical intervention

Description

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.

Time Frame

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

Title

Assess clinical performance in terms of length of stay (days) at hospital

Description

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.

Time Frame

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

Title

Assess clinical performance in terms of number of outer layer dressing changes

Description

Outer dressings will be changed at each visit (from Visit 3 and onwards) if deemed appropriate by the Investigator

Time Frame

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

Title

Evaluate scar quality

Description

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.

Time Frame

3, 6 and 12 months post burn

Title

Monitor Adverse Events (AEs)

Description

Frequency, intensity and seriousness of AEs

Time Frame

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

Title

Monitor Device Deficiencies (DDs)

Description

Frequency and nature of DDs

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Johana Kuncova-Kallio

Phone

+35820415111

Email

johana.kuncova-kallio@upm.com

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Punakallio

Phone

+358415324344

Email

laura.punakallio@upm.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fredrik Huss

Organizational Affiliation

Burn Centre, Uppsala University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Moustafa Elmasry

Organizational Affiliation

Burn Centre, Linköping University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Burn Centre, Uppsala University Hospital

City

Uppsala

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fredrik Huss

First Name & Middle Initial & Last Name & Degree

Fredrik Huss

Burns

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial