water resistante padding
Device- Delta-Dry® Softliner
- Tensoban®
- Delta-Dry®
NCT Number: NCT05347927
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.
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Notify Me18 year and older
All sexes
Observational
Ommelander Ziekenhuis, Groningen, Scheemda, Netherlands
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 3 weeks
Quantity of bacteria in the skin microbiome
Time frame: 3 weeks
Taxonomic composition of skin microbiome
Time frame: 3 weeks
Alpha diversity of skin microbiome
Time frame: 3 weeks
Beta diversity skin microbiome
Time frame: 3 weeks
Time frame: 3 weeks
Time frame: 3 weeks
Time frame: 3 weeks
BSN Medical GmbH
Industry
Exploratory, Prospective, Multicenter, Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome
Acronym: Microbiome II
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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