Skin MicrobiomeMicrobiome IINCT05347927
Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome
An observational study of Skin Microbiome and Undercast Materials, run by BSN Medical GmbH at 3 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Microbiome, Undercast Materials
- What is being tested?
- water resistante padding and non water resistante padding
- Type of treatment
- Medical device
- How many people
- 108 participants
- Where
- 3 sitesNetherlands
- Study dates
- 30 Oct 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects with broken forwarm receiving short arm cast
Who may be able to join
- 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))
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Wilhelmina Ziekenhuis Assen (Assen, NL)
Assen, 9401 RK
Ommelander Ziekenhuis
Groningen, Scheemda, 9679 BJ
Leids Universitair Medisch Centrum (Leiden, NL)
Leiden, 2333 ZA
About this study
Official title: Exploratory, Prospective, Multicenter, Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome
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
- Being tested
- water resistante padding, non water resistante padding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
water resistante paddingDevice
- Delta-Dry® Softliner
- Tensoban®
- Delta-Dry®
non water resistante paddingDevice
- Delta-Net® Stockinette
- Delta-Rol®
| Study group | Role | What they receive |
|---|---|---|
| Test group | will receive water resistante padding and a cast Receives: Device: water resistante padding | |
| Control group | will receive traditional non-water resistante padding and cast Receives: Device: non water resistante padding |
What is being measured
The primary outcome is the main question the study is designed to answer.
products´ influence on skin microbiome during fracture management
Quantity of bacteria in the skin microbiome
Measured: 3 weeks
products´ influence on skin microbiome during fracture management
Taxonomic composition of skin microbiome
Measured: 3 weeks
products´ influence on skin microbiome during fracture management
Alpha diversity of skin microbiome
Measured: 3 weeks
products´ influence on skin microbiome during fracture management
Beta diversity skin microbiome
Measured: 3 weeks
Secondary outcomes (4)
Number of adverse events during study per product
Measured: 3 weeks
General product performance
Measured: 3 weeks
Treatment comfort
Measured: 3 weeks
Impact on daily life activities
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start30 Oct 2022
- Primary completion30 Sep 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin MicrobiomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- BSN Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347927
- Sponsor's protocol ID
- C2753
- Acronym
- Microbiome II
- Status last verified
- Jan 2025
- First submitted
- 21 Apr 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory, Prospective, Multicenter, Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome
- ClinicalTrials.gov ID
- NCT05347927
- Acronym / sponsor ID
- Microbiome II / C2753
- Conditions
- Skin Microbiome, Undercast Materials
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- BSN Medical GmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2022 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Device: water resistante paddingwill receive water resistante padding and a cast |
| Control group | – | Device: non water resistante paddingwill receive traditional non-water resistante padding and cast |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects with broken forwarm receiving short arm cast
Key inclusion criteria (5 listed)
- 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))
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| water resistante padding* Delta-Dry® Softliner * Tensoban® * Delta-Dry® | Device | Test group |
| non water resistante padding* Delta-Net® Stockinette * Delta-Rol® | Device | Control group |
Primary outcome
products´ influence on skin microbiome during fracture management
Time frame: 3 weeks
Quantity of bacteria in the skin microbiome
products´ influence on skin microbiome during fracture management
Time frame: 3 weeks
Taxonomic composition of skin microbiome
products´ influence on skin microbiome during fracture management
Time frame: 3 weeks
Alpha diversity of skin microbiome
products´ influence on skin microbiome during fracture management
Time frame: 3 weeks
Beta diversity skin microbiome
4 secondary outcomes
Number of adverse events during study per product
Time frame: 3 weeks
General product performance
Time frame: 3 weeks
Treatment comfort
Time frame: 3 weeks
Impact on daily life activities
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Microbiome and Undercast Materials, run by BSN Medical GmbH at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
products´ influence on skin microbiome during fracture management (time frame: 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025; AzTrials last refreshed its copy on 1 Nov 2026.