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

BSN Medical

Status: Completed

Conditions: Skin Microbiome; Undercast Materials

Treatments: Device: water resistante padding; Device: non water resistante padding

Study type: Observational

Funder types: Industry

Identifiers

NCT05347927

C2753

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

108 participants in 2 patient groups

Test group

Description:

will receive water resistante padding and a cast

Treatment:

Device: water resistante padding

Control group

Description:

will receive traditional non-water resistante padding and cast

Treatment:

Device: non water resistante padding