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

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.

Study Overview

• Status: Completed
• Conditions: Skin Microbiome; Undercast Materials
• Intervention / Treatment: Device: water resistante padding; Device: non water resistante padding

• Study Type: Observational
• Enrollment (Actual): 108

Contacts and Locations

Study Locations

• Netherlands
  • Assen, Netherlands, 9401 RK
    • Wilhelmina Ziekenhuis Assen (Assen, NL)
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum (Leiden, NL)
  • Scheemda
    • Groningen, Scheemda, Netherlands, 9679 BJ
      • Ommelander Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects with broken forwarm receiving short arm cast

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test group; will receive water resistante padding and a cast	Device: water resistante padding; Delta-Dry® Softliner; Tensoban®; Delta-Dry®
Control group; will receive traditional non-water resistante padding and cast	Device: non water resistante padding; Delta-Net® Stockinette; Delta-Rol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
products´ influence on skin microbiome during fracture management	Quantity of bacteria in the skin microbiome	3 weeks
products´ influence on skin microbiome during fracture management	Taxonomic composition of skin microbiome	3 weeks
products´ influence on skin microbiome during fracture management	Alpha diversity of skin microbiome	3 weeks
products´ influence on skin microbiome during fracture management	Beta diversity skin microbiome	3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BSN Medical GmbH

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: C2753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No