Bacterial ColonizationNCT06831305
Bacterial Colonization on Nails Covered With a Methacrylic Coating
A study testing Comparison of microbiological sampling on natural nails and Comparison of microbiological sampling on methacrylic nails in people with Bacterial Colonization, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
In the research, the investigators will monitor the bacterial colonization of nails coated with a methacrylic coating Read more about this study
- Who is it for?
- Ages 16 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Colonization
- What is being tested?
- Comparison of microbiological sampling on natural nails and Comparison of microbiological sampling on methacrylic nails
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 80 years
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- nurses, doctors and respiratory physiotherapists employed in high-risk wards for patients
- healthy nail surface and cuticle
Who cannot join
- subjects with damaged nails or cuticles
- operating room staff using surgical hand brushing and staff in general nursing wards.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bacterial Colonization of Nails With Methacrylic Coating in Relation to the Formation of Biofilms and Healthcare-associated Infections
In the research, the investigators will monitor the bacterial colonization of nails coated with a methacrylic coating
Read the detailed description
It is known that the hand hygiene of healthcare workers is extremely important in order to prevent health-related infections. The effectiveness of hand disinfection can be affected by aspects of hand hygiene such as long nails and fingernail applications. In order to determine whether and to what extent fingernails applied among healthcare workers pose a risk of transmission of potentially pathogenic bacteria, and until what day artificial fingernails are safe in healthcare workers, the investigators will monitor bacterial colonization on nails with UV-cured methacrylic fingernails lamp and compared it with a control group of natural nails without application.
- Conditions
- Bacterial Colonization
- Being tested
- Comparison of microbiological sampling on natural nails, Comparison of microbiological sampling on methacrylic nails
- Keywords
- methacrylates, nails, desinfection, transmission of infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of microbiological sampling on natural nailsDiagnostic test
Also called natural nails
Comparison of microbiological sampling before and after hand desinfection
Comparison of microbiological sampling on methacrylic nailsDiagnostic test
Comparison of microbiological sampling on methacrylic nails
| Study group | Role | What they receive |
|---|---|---|
| natural nails | Active comparator | Alcohol hand sanitizer 3ml applied into hands, spread over hands up to the wrist and rubbed until dry on natural nails. Receives: Diagnostic Test: Comparison of microbiological sampling on natural nails |
| methaacrylic nails | Active comparator | Alcohol hand sanitizer 3ml applied into hands, spread over hands up to the wrist and rubbed until dry on methaacrylic nails Receives: Diagnostic Test: Comparison of microbiological sampling on methacrylic nails |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of microbial colonization between natural and methacrylate nails
Measured: From day 1st to the end of treatment on day 14th
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial ColonizationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831305
- Sponsor's protocol ID
- 0120-301/2024-2711-3
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Colonization of Nails With Methacrylic Coating in Relation to the Formation of Biofilms and Healthcare-associated Infections
- ClinicalTrials.gov ID
- NCT06831305
- Acronym / sponsor ID
- 0120-301/2024-2711-3
- Conditions
- Bacterial Colonization
- Keywords
- methacrylates, nails, desinfection, transmission of infections
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Feb 2025 (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.
In the research, the investigators will monitor the bacterial colonization of nails coated with a methacrylic coating
Detailed description
It is known that the hand hygiene of healthcare workers is extremely important in order to prevent health-related infections. The effectiveness of hand disinfection can be affected by aspects of hand hygiene such as long nails and fingernail applications. In order to determine whether and to what extent fingernails applied among healthcare workers pose a risk of transmission of potentially pathogenic bacteria, and until what day artificial fingernails are safe in healthcare workers, the investigators will monitor bacterial colonization on nails with UV-cured methacrylic fingernails lamp and compared it with a control group of natural nails without application.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| natural nails | Active comparator | Diagnostic Test: Comparison of microbiological sampling on natural nailsAlcohol hand sanitizer 3ml applied into hands, spread over hands up to the wrist and rubbed until dry on natural nails. |
| methaacrylic nails | Active comparator | Diagnostic Test: Comparison of microbiological sampling on methacrylic nailsAlcohol hand sanitizer 3ml applied into hands, spread over hands up to the wrist and rubbed until dry on methaacrylic nails |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- nurses, doctors and respiratory physiotherapists employed in high-risk wards for patients
- healthy nail surface and cuticle
Key exclusion criteria (2 listed)
- subjects with damaged nails or cuticles
- operating room staff using surgical hand brushing and staff in general nursing wards.
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 |
|---|---|---|
| Comparison of microbiological sampling on natural nailsAlso: natural nailsComparison of microbiological sampling before and after hand desinfection | Diagnostic test | natural nails |
| Comparison of microbiological sampling on methacrylic nailsComparison of microbiological sampling on methacrylic nails | Diagnostic test | methaacrylic nails |
Primary outcome
Comparison of microbial colonization between natural and methacrylate nails
Time frame: From day 1st to the end of treatment on day 14th
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of microbiological sampling on natural nails and Comparison of microbiological sampling on methacrylic nails in people with Bacterial Colonization, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Comparison of microbial colonization between natural and methacrylate nails (time frame: From day 1st to the end of treatment on day 14th). 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 26 Mar 2025.