Post-market Clinical Follow-up Study for a CE Marked Wound Care Product (FibDex®)

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.

Inclusion Criteria:Subjects aged at least 18 years when signing the informed consentSubjects 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 womenSubjects with solid organ transplantationAny other medical condition, compliance, or medication according to Investigator ́s evaluation considered as justified reason for exclusionVulnerable 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.