NCT05347927

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: BSN Medical GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Skin Microbiome
• Undercast Materials

Interventions

Type	Name	Description
DEVICE	water resistante padding	* Delta-Dry® Softliner * Tensoban® * Delta-Dry®
DEVICE	non water resistante padding	* Delta-Net® Stockinette * Delta-Rol®

Timeline

• Start date: 2022-10-30
• Primary completion: 2024-09-30
• Completion: 2024-12-31
• First posted: 2022-04-27
• Last updated: 2025-01-31

Locations

3 sites across 1 country: Netherlands