Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®) (NCT05666999) | Clinical Trial Compass
TerminatedNot Applicable
Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®)
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.
Finland18 participantsStarted 2023-05-15
Plain-language 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 site wounds and to compare clinical performance and safety of FibDex® to current clinical practice.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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)
What they're measuring
1
Wound healing
Timeframe: Post operative day 21
2
Wound healing
Timeframe: between post operative day 28-42, if not healed in 3 weeks