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

NCT05347927 | Completed

• 1 other identifier: C2753
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 3

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.

Conditions

Skin Microbiome; Undercast Materials

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (2)

Test group

will receive water resistante padding and a cast

Device: water resistante padding

Control group

will receive traditional non-water resistante padding and cast

Device: non water resistante padding

Interventions

water resistante padding DEVICE

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

Test group

non water resistante padding DEVICE

* Delta-Net® Stockinette * Delta-Rol®

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with broken forwarm receiving short arm cast

You may qualify if:

• Subject ≥ 18 years of age
• Patient is physically and mentally able to participate in this study
• Proper understanding of the Dutch language
• Signed informed consent

You may not qualify if:

• Subject \<18 years of age
• Pregnancy, breast feeding
• Participation in other clinical trials
• Patient is neither physically nor mentally able to participate in this study
• Non-intact skin in treatment area (including dermatological issues)
• Patients with impaired (e.g. Cortisone skin, extremely dry skin, parchment skin) or damaged skin with either a surgical wound or a traumatic wound
• Medical treatment prior casting which could influence the microbiome
• Known Blood Circulatory Diseases
• Known Lymphedema or any general disorder of the lymphatic system
• Known Osteoporosis
• Known Diabetes
• Knowing of one of the following illnesses that might require regular systemic medication: cancer, rheumatic disease
• Intolerability or documented allergies against cast materials
• Subjects with not "normal" (unusual) hygienic behavior
• Suspected drug addiction or alcohol abuse

Sponsors & Collaborators

• BSN Medical GmbH: lead

Study Sites (3)

Ommelander Ziekenhuis

Groningen, Scheemda, 9679 BJ, Netherlands

Location

Wilhelmina Ziekenhuis Assen (Assen, NL)

Assen, 9401 RK, Netherlands

Location

Leids Universitair Medisch Centrum (Leiden, NL)

Leiden, 2333 ZA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Skin microbiome swabs are collected for micribiome analysis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: October 30, 2022
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (3)