Status:
COMPLETED
Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome
Lead Sponsor:
BSN Medical GmbH
Conditions:
Skin Microbiome
Undercast Materials
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- Patients diagnosed HIV-positive or with infectious hepatitis based on self-declaration by subjects
Key Trial Info
Start Date :
October 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT05347927
Start Date
October 30 2022
End Date
December 31 2024
Last Update
January 31 2025
Active Locations (3)
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1
Ommelander Ziekenhuis
Groningen, Scheemda, Netherlands, 9679 BJ
2
Wilhelmina Ziekenhuis Assen (Assen, NL)
Assen, Netherlands, 9401 RK
3
Leids Universitair Medisch Centrum (Leiden, NL)
Leiden, Netherlands, 2333 ZA