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

Completed

• Conditions: Skin Microbiome; Undercast Materials
• Interventions: Device: water resistante padding; Device: non water resistante padding

• Registration Number: NCT05347927
• Lead Sponsor: BSN Medical GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-27
• Study Start: 2022-10-30
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

1. Subject ≥ 18 years of age
2. Patient is physically and mentally able to participate in this study
3. Proper understanding of the Dutch language
4. Signed informed consent
5. Fractures to be treated with a short-arm cast without thumb inclusion for the period of 3 weeks (e.g. 2R3A1 = radial styloid avulsion, 2R3A2 = Simple radial fracture, 2U3A1 = Ulnar fracture of the base of the styloid process, 2U3A2= Simple distal ulna fracture, 2R3B1 = Intraarticular fracture of the styloid process of the radius (not displaced) or Triquetrum fracture (non AO classified))

Exclusion Criteria

1. Subject <18 years of age
2. Pregnancy, breast feeding
3. Participation in other clinical trials
4. Patient is neither physically nor mentally able to participate in this study
5. Non-intact skin in treatment area (including dermatological issues)
6. Patients with impaired (e.g. Cortisone skin, extremely dry skin, parchment skin) or damaged skin with either a surgical wound or a traumatic wound
7. Medical treatment prior casting which could influence the microbiome
8. Known Blood Circulatory Diseases
9. Known Lymphedema or any general disorder of the lymphatic system
10. Known Osteoporosis
11. Known Diabetes
12. Knowing of one of the following illnesses that might require regular systemic medication: cancer, rheumatic disease
13. Intolerability or documented allergies against cast materials
14. Subjects with not "normal" (unusual) hygienic behavior
15. Suspected drug addiction or alcohol abuse
16. Patients diagnosed HIV-positive or with infectious hepatitis based on self-declaration by subjects

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Test group	water resistante padding	will receive water resistante padding and a cast
Control group	non water resistante padding	will receive traditional non-water resistante padding and cast

Primary Outcome Measures

Name	Time	Method
products´ influence on skin microbiome during fracture management	3 weeks	Beta diversity skin microbiome

Secondary Outcome Measures

Name	Time	Method
Number of adverse events during study per product	3 weeks
Treatment comfort	3 weeks
Impact on daily life activities	3 weeks
General product performance	3 weeks

Trial Locations

Locations (3)

Ommelander Ziekenhuis; 🇳🇱 Groningen, Scheemda, Netherlands

Wilhelmina Ziekenhuis Assen (Assen, NL); 🇳🇱 Assen, Netherlands

Leids Universitair Medisch Centrum (Leiden, NL); 🇳🇱 Leiden, Netherlands