Skin TransplantationNCT05666999
Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®)
A study testing FibDex®, Suprathel and Aquacel Foam in people with Skin Transplantation, run by UPM-Kymmene Corporation at 1 site in Finland.
Trial summary
FibDex® 2-2022 is a sponsored, post-marketing clinical follow-up (PMCF) study to monitor the clinical performance and safety of the CE marked product nanofibrillar cellulose (NFC) wound dressing, FibDex®, when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Transplantation
- What is being tested?
- FibDex®, Suprathel and Aquacel Foam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFinland
- Study dates
- 15 May 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged at least 18 years when signing the informed consent
- Subjects with wounds that need split thickness skin grafting (STSG)
- Subjects that have at least one STSG donor site wound at least 5 x 5 cm and maximum 20 x 30 cm or two STSG donor site wounds of same size, at least 5 x 5 cm and maximum 20 x 30 cm, anatomically close to each other or on anatomically similar area in the opposite extremity or body area.
Who cannot join
- Subjects allergic to, or have had an allergic reaction to IMDs components (wood cellulose and polypropylene) or the comparator's components (polylactic acid-based copolymer or natrium carboxymethylcellulose)
- Pregnant or breast-feeding women
- Subjects with solid organ transplantation
- Any other medical condition, compliance, or medication according to Investigator ́s evaluation considered as justified reason for exclusion
- Vulnerable subject (such as retarded person, person in nursing home, prisoner, patient in emergency)
- STSG donor site wound(s) on sensitive skin areas, such as the facial area, the genital area or mucous membranes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®) to Compare the Clinical Performance and Safety in it's Established Intended Use of Split Thickness Skin Graft Donor Site Wounds
FibDex® 2-2022 is a sponsored, post-marketing clinical follow-up (PMCF) study to monitor the clinical performance and safety of the CE marked product nanofibrillar cellulose (NFC) wound dressing, FibDex®, when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds and to compare clinical performance and safety of FibDex® to current clinical practice.
Read the detailed description
STSG is a reconstructive procedure that is most used for management of burn injuries. Skin harvesting creates a new partial thickness wound, a donor site that causes additional pain for the patient during the postoperative recovery. Therefore, and because wound healing complications, such as delayed healing and infections, are common donor sites, the donor sites are problematic to treat. A dressing that wound provide optimal healing, low costs, and minimal pain with few dressing changes would be a preferred choice for treatment of donor sites. NFC wound dress, like FibDex, are used for providing these kinds of benefits to patients and better healing result.
This is a sponsored prospective, randomized, controlled, non-blinded, non-inferiority study. Subjects will be treated with the IMD or the comparator and act as their own controls. Subjects will be followed up for up to POD 365. Purpose of this PMCF study for FibDex is to gather data for updating the clinical evaluation and assess if new data gained over time has a bearing on the risk-benefit assessment or if there are some needs to make changes to the product or the package. Clinical evaluation is ongoing and happens throughout the medical devices lifetime. Clinical safety need to be analyzed periodically according to MDR requirements. For class IIb products, like FibDex, it means clinical safety update every year. This study is part of that evaluation.
Aim is to get 48 randomized STSG wounds. Study methods during this study are using the IMD or the comparator after the surgery, subject diaries, pain questionnaires, scar quality assessments by investigator and study subjects and visual observation by the delegated site staff. Also, photos of the healing process will be collected.
- Conditions
- Skin Transplantation
- Being tested
- FibDex®, Suprathel, Aquacel Foam
- Keywords
- Skin Transplantation, Donor site, STSG, FibDex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibDex®Device
To monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds.
SuprathelDevice
To monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds.
Aquacel FoamDevice
To monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds.
| Study group | Role | What they receive |
|---|---|---|
| FibDex | Other | IMD Receives: Device: FibDex® |
| Suprathel | Active comparator | Primary Comparator. Receives: Device: Suprathel |
| Aquacel Foam | Active comparator | Secondary Comparator. Receives: Device: Aquacel Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing
Wound healing percentage (%) is evaluated by the investigator on POD 21 by removing the dressing and assessing the epithelization.
Measured: Post operative day 21
Wound healing
Wound healing percentage (%) is evaluated by the investigator
Measured: between post operative day 28-42, if not healed in 3 weeks
Secondary outcomes (7)
Subject pain
Using a patient diary and NRS scale 0-10 (0= no pain,10= worst pain ever)
Measured: Diary for post operative days 0 to 21, NRS-scale 1 year.
Epithelialization percentage
healing process evaluated by the investigator
Measured: post operative day 21
Scar quality
quality of the scar evaluated by patient
Measured: day 365
Scar quality
quality of the scar evaluated by observer (investigator)
Measured: 1 year
Adverse events
Total number of adverse events and device defects
Measured: 1 year
Workload during the study visits
To monitor the workload needed e.g. number of extra dressings before post operative day 21 evaluation by using case report forms
Measured: Post operative day 21
Safety of Investigational material
Number of IMD or comparator related adverse events
Measured: post operative day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start15 May 2023
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Why it stopped: UPM Kymmene Oyj announced on April 2, 2025, the closure of Biomedicals business. As a result, FibDex manufacturing and sales will discontinue. The premature termination is due to business decision, not related to any safety concerns of FibDex.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- UPM-Kymmene Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Helsinki University Central Hospital
- Responsible party
- Sponsor
- Investigators
- Kari Luukko, Dr.Tech, Study director, Director, Quality Assurance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666999
- Sponsor's protocol ID
- FibDex 2-2022
- Status last verified
- Aug 2025
- First submitted
- 12 Sep 2022
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®) to Compare the Clinical Performance and Safety in it's Established Intended Use of Split Thickness Skin Graft Donor Site Wounds
- ClinicalTrials.gov ID
- NCT05666999
- Acronym / sponsor ID
- FibDex 2-2022
- Conditions
- Skin Transplantation
- Keywords
- Skin Transplantation, Donor site, STSG, FibDex
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: UPM Kymmene Oyj announced on April 2, 2025, the closure of Biomedicals business. As a result, FibDex manufacturing and sales will discontinue. The premature termination is due to business decision, not related to any safety concerns of FibDex.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- UPM-Kymmene CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Helsinki University Central Hospital
- Study start
- 15 May 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FibDex® 2-2022 is a sponsored, post-marketing clinical follow-up (PMCF) study to monitor the clinical performance and safety of the CE marked product nanofibrillar cellulose (NFC) wound dressing, FibDex®, when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds and to compare clinical performance and safety of FibDex® to current clinical practice.
Detailed description
STSG is a reconstructive procedure that is most used for management of burn injuries. Skin harvesting creates a new partial thickness wound, a donor site that causes additional pain for the patient during the postoperative recovery. Therefore, and because wound healing complications, such as delayed healing and infections, are common donor sites, the donor sites are problematic to treat. A dressing that wound provide optimal healing, low costs, and minimal pain with few dressing changes would be a preferred choice for treatment of donor sites. NFC wound dress, like FibDex, are used for providing these kinds of benefits to patients and better healing result.
This is a sponsored prospective, randomized, controlled, non-blinded, non-inferiority study. Subjects will be treated with the IMD or the comparator and act as their own controls. Subjects will be followed up for up to POD 365. Purpose of this PMCF study for FibDex is to gather data for updating the clinical evaluation and assess if new data gained over time has a bearing on the risk-benefit assessment or if there are some needs to make changes to the product or the package. Clinical evaluation is ongoing and happens throughout the medical devices lifetime. Clinical safety need to be analyzed periodically according to MDR requirements. For class IIb products, like FibDex, it means clinical safety update every year. This study is part of that evaluation.
Aim is to get 48 randomized STSG wounds. Study methods during this study are using the IMD or the comparator after the surgery, subject diaries, pain questionnaires, scar quality assessments by investigator and study subjects and visual observation by the delegated site staff. Also, photos of the healing process will be collected.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FibDex | Other | Device: FibDex®IMD |
| Suprathel | Active comparator | Device: SuprathelPrimary Comparator. |
| Aquacel Foam | Active comparator | Device: Aquacel FoamSecondary Comparator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects aged at least 18 years when signing the informed consent
- Subjects with wounds that need split thickness skin grafting (STSG)
- Subjects that have at least one STSG donor site wound at least 5 x 5 cm and maximum 20 x 30 cm or two STSG donor site wounds of same size, at least 5 x 5 cm and maximum 20 x 30 cm, anatomically close to each other or on anatomically similar area in the opposite extremity or body area.
Key exclusion criteria (6 listed)
- Subjects allergic to, or have had an allergic reaction to IMDs components (wood cellulose and polypropylene) or the comparator's components (polylactic acid-based copolymer or natrium carboxymethylcellulose)
- Pregnant or breast-feeding women
- Subjects with solid organ transplantation
- Any other medical condition, compliance, or medication according to Investigator ́s evaluation considered as justified reason for exclusion
- Vulnerable subject (such as retarded person, person in nursing home, prisoner, patient in emergency)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibDex®To monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds. | Device | FibDex |
| SuprathelTo monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds. | Device | Suprathel |
| Aquacel FoamTo monitor and compare the clinical performance and safety of the CE marked wound care product (FibDex®) when used according to its intended use for patients or individuals with split thickness skin graft (STSG) donor site wounds. | Device | Aquacel Foam |
Primary outcome
Wound healing
Time frame: Post operative day 21
Wound healing percentage (%) is evaluated by the investigator on POD 21 by removing the dressing and assessing the epithelization.
Wound healing
Time frame: between post operative day 28-42, if not healed in 3 weeks
Wound healing percentage (%) is evaluated by the investigator
7 secondary outcomes
Subject pain
Time frame: Diary for post operative days 0 to 21, NRS-scale 1 year.
Epithelialization percentage
Time frame: post operative day 21
Scar quality
Time frame: day 365
Scar quality
Time frame: 1 year
Adverse events
Time frame: 1 year
Workload during the study visits
Time frame: Post operative day 21
Safety of Investigational material
Time frame: post operative day 21
Results and safety
The study was stopped early (reason given: UPM Kymmene Oyj announced on April 2, 2025, the closure of Biomedicals business. As a result, FibDex manufacturing and sales will discontinue. The premature termination is due to business decision, not related to any safety concerns of FibDex.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kari Luukko, Dr.Tech study director
Director, Quality Assurance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FibDex®, Suprathel and Aquacel Foam in people with Skin Transplantation, run by UPM-Kymmene Corporation at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: UPM Kymmene Oyj announced on April 2, 2025, the closure of Biomedicals business. As a result, FibDex manufacturing and sales will discontinue. The premature termination is due to business decision, not related to any safety concerns of FibDex.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing (time frame: Post operative day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.