An interventional study of FibDex® and Suprathel in Skin Transplantation, sponsored by UPM-Kymmene Corporation. Terminated at 1 site in Finland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by UPM-Kymmene Corporation · Not applicable, Interventional, and Other
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.
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.
UPM-Kymmene Corporation is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IMD
Device: FibDex®
Primary Comparator.
Device: Suprathel
Secondary Comparator.
Device: Aquacel Foam
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.
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.
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.
Wound healing
Wound healing percentage (%) is evaluated by the investigator on POD 21 by removing the dressing and assessing the epithelization.
Time frame: Post operative day 21
Wound healing
Wound healing percentage (%) is evaluated by the investigator
Time frame: between post operative day 28-42, if not healed in 3 weeks
Subject pain
Using a patient diary and NRS scale 0-10 (0= no pain,10= worst pain ever)
Time frame: Diary for post operative days 0 to 21, NRS-scale 1 year.
Epithelialization percentage
healing process evaluated by the investigator
Time frame: post operative day 21
Scar quality
quality of the scar evaluated by patient
Time frame: day 365
Scar quality
quality of the scar evaluated by observer (investigator)
Time frame: 1 year
Adverse events
Total number of adverse events and device defects
Time frame: 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
Time frame: Post operative day 21
Safety of Investigational material
Number of IMD or comparator related adverse events
Time frame: post operative day 21
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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UPM-Kymmene Corporation