This clinical study will evaluate the clinical performance and the safety of the CE-marked casting and padding materials when used in routine fracture care without any additional invasive methods and within the intended use. As primary objective the cast therapy´s influence on skin microbiome during fracture management will be investigated. Further, the influence of the padding material on the skin microbiome, device comfort, skin conditions, and impact on daily life activities as well as HCP´s and patient´s satisfaction and general product safety and performance are considered as secondary outcomes.
Study Type
OBSERVATIONAL
Enrollment
108
* Delta-Dry® Softliner * Tensoban® * Delta-Dry®
* Delta-Net® Stockinette * Delta-Rol®
Ommelander Ziekenhuis
Groningen, Scheemda, Netherlands
Wilhelmina Ziekenhuis Assen (Assen, NL)
Assen, Netherlands
Leids Universitair Medisch Centrum (Leiden, NL)
Leiden, Netherlands
products´ influence on skin microbiome during fracture management
Quantity of bacteria in the skin microbiome
Time frame: 3 weeks
products´ influence on skin microbiome during fracture management
Taxonomic composition of skin microbiome
Time frame: 3 weeks
products´ influence on skin microbiome during fracture management
Alpha diversity of skin microbiome
Time frame: 3 weeks
products´ influence on skin microbiome during fracture management
Beta diversity skin microbiome
Time frame: 3 weeks
Number of adverse events during study per product
Time frame: 3 weeks
General product performance
Time frame: 3 weeks
Treatment comfort
Time frame: 3 weeks
Impact on daily life activities
Time frame: 3 weeks
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