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

NCT05347927 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2025-01-31

No results posted yet for this study

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

DEVICE

water resistante padding

* Delta-Dry® Softliner * Tensoban® * Delta-Dry®

DEVICE

non water resistante padding

* Delta-Net® Stockinette * Delta-Rol®

Sponsors & Collaborators

  • BSN Medical GmbH

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-30
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05347927 on ClinicalTrials.gov