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Exploratory, Prospective, Multicenter, Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Ommelander Ziekenhuis
Groningen, Scheemda, Netherlands
Wilhelmina Ziekenhuis Assen (Assen, NL)
Assen, Netherlands
Leids Universitair Medisch Centrum (Leiden, NL)
Leiden, Netherlands
Start Date
October 30, 2022
Primary Completion Date
September 30, 2024
Completion Date
December 31, 2024
Last Updated
January 31, 2025
108
ACTUAL participants
water resistante padding
DEVICE
non water resistante padding
DEVICE
Lead Sponsor
BSN Medical GmbH
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07193290