Clinical trial NCT05347927: Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome
Official title: Exploratory, Prospective, Multicenter, Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Microbiome
Undercast Materials
Lead sponsor: BSN Medical GmbH
Sponsor class: INDUSTRY
First posted: 2022-04-27
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with broken forwarm receiving short arm cast

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.


Eligibility criteria: 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

Primary outcomes:
measure: products´ influence on skin microbiome during fracture management
timeFrame: 3 weeks
measure: products´ influence on skin microbiome during fracture management
timeFrame: 3 weeks
measure: products´ influence on skin microbiome during fracture management
timeFrame: 3 weeks
measure: products´ influence on skin microbiome during fracture management
timeFrame: 3 weeks
Secondary outcomes:
measure: Number of adverse events during study per product
timeFrame: 3 weeks
measure: General product performance
timeFrame: 3 weeks
measure: Treatment comfort
timeFrame: 3 weeks
measure: Impact on daily life activities
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Ommelander Ziekenhuis
state: Scheemda
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis Assen (Assen, NL)
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (Leiden, NL)
Study officials:
References: