Skin Microbiome, Undercast Materials
Conditions
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.
Interventions
DEVICEwater resistante padding
* Delta-Dry® Softliner * Tensoban® * Delta-Dry®
DEVICEnon water resistante padding
* Delta-Net® Stockinette * Delta-Rol®
Sponsors
BSN Medical GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| products´ influence on skin microbiome during fracture management | 3 weeks | Quantity of bacteria in the skin microbiome |
Secondary
| 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 |
Countries
Netherlands
Outcome results
None listed