Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome — Microbiome II

Skin Microbiome Clinical Trial

Official title:
Exploratory, Prospective, Multicenter, Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Skin Microbiome

Clinical Trial Details

NCT number	NCT05347927
Study type	Observational
Source	BSN Medical GmbH
Contact	Hardy Schweigel, Dr.
Phone	+49 152 2775 2954
Email	hardy.schweigel@essity.com
Status	Recruiting
Phase
Start date	October 30, 2022
Completion date	August 31, 2024

View Details

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