Bacterial InfectionsRBGNCT05210920
RBG: Regular, Bare, Gel: Does Type of Nail Polish Affect Bacterial Counts After Surgical Scrubbing?
A study testing Nail polish application in people with Bacterial Infections and Surgical Site Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: The purpose of this study is to evaluate if type of nail polish (gel polish or regular polish) has an effect on the number of bacterial colonies on finger nails after surgical scrubbing. Participants: The potential participants are healthcare providers with patient interaction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections, Surgical Site Infection, Contaminated Medical or Biological Substances
- What is being tested?
- Nail polish application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2021to 31 May 2023
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthcare provider who provides patient care
Who cannot join
- Active dermatitis or other skin abnormality
- Allergy to chlorhexidine scrub soap
Trial locations and contacts
1 site in 1 country.
About this study
Purpose: The purpose of this study is to evaluate if type of nail polish (gel polish or regular polish) has an effect on the number of bacterial colonies on finger nails after surgical scrubbing.
Participants: The potential participants are healthcare providers with patient interaction. Exclusion criteria include evidence of active dermatitis or other skin abnormalities, or allergy to chlorhexidine.
Intervention: Participants will have gel nail polish applied to one finger of their dominant hand, and regular polish applied to another finger of their dominant hand. Bacterial swabs will be collected from these two fingers, as well as the from the adjacent finger with no nail polish. Specimen collection will occur both before and after scrubbing with surgical soap. Bacterial counts will be compared between the three groups to determine the association between the presence of nail polish and nail polish type on bacterial counts after surgical scrubbing. Specimen collection will not take place during scrubbing for actual patient care.
Read the detailed description
Potential participants will be identified by word of mouth, flyers and institutional networking. Once a participant agrees to enroll, they will have each type of nail polish placed on a single finger on their dominant hand (gel on one finger and regular polish on another). A third finger will be left bare to serve as a control. On day 1-3 after nail polish application, the participant will have cotton swab samples taken from underneath their nail and over their nail bed, on each of the two polished nails, as well as the adjacent bare nail. These bacterial samples will be collected both before and after scrubbing (utilizing a nail pick, scrub brush, and chlorhexidine). This process will be repeat on day 5-7 after nail polish application. These samples will then be assessed for bacterial colonies in the Microbiology laboratory. Participant variables will be recorded in RedCap (scrubbing frequency, % of chipping in nails (in quartiles: 0, < 25%, < 50%, <75%, >75%, Gender, Age, Level of training, Specialty, Type of polish, Dominant hand, Duration since application of polish, Nail length in mm, Race, BMI, Type of bacteria isolated from samples).
Summary of Study Visits:
Day 0 Participants will have polish applied on two fingers on their dominant hand, one with gel polish and one with regular polish.
Day 1-3 The participants will return for their first swabs. Bacterial swabs will be obtained from the nail bed and under the fingernail of 3 fingers: the regular polish nail, the gel polish nail and a bare nail adjacent to the two polished nails, before and after a standard 5-minute scrub with chlorhexidine.
Day 5-7 The participants will return for the same procedure described above. The nail polish can be removed after this intervention. No further follow-up or involvement for participants
- Conditions
- Bacterial Infections, Surgical Site Infection, Contaminated Medical or Biological Substances
- Being tested
- Nail polish application
- Medical subject headings
- Bacterial Infections, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nail polish applicationOther
After application of nail polish as described, participants will have bacterial swabs collected from the under the fingernail and from the nail bed of the three assigned fingers on their dominant hand, both before and after scrubbing with a chlorhexidine surgical scrubbing brush.
| Study group | Role | What they receive |
|---|---|---|
| Regular Nail Polish | Experimental | Participants will have regular nail polish applied to one fingernail of their dominant hand Receives: Other: Nail polish application |
| Gel Nail Polish | Experimental | Participants will have gel nail polish applied to one fingernail of their dominant hand Receives: Other: Nail polish application |
| Bare Nail | No intervention | Participants will have one fingernail of their dominant hand left bare for comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Counts Before Scrubbing Day 1-3
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Measured: 1-3 days after polish application
Bacterial Counts After Scrubbing Day 1-3
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Measured: 1-3 days after polish application
Bacterial Counts Before Scrubbing Day 5-7
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Measured: 5-7 days after polish application
Bacterial Counts After Scrubbing Day 5-7
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Measured: 5-7 days after polish application
Secondary outcomes (4)
Percent of nail polish flaking (%) Day 1-3
Percent of nail polish flaking (%) will be measured for each type of polish
Measured: 1-3 days after polish application
Percent of nail polish flaking (%) Day 5-7
Percent of nail polish flaking (%) will be measured for each type of polish
Measured: 5-7 days after polish application
Nail growth (mm) Day 1-3
Nail growth (mm) will be measured for each group
Measured: 1-3 days after polish application
Nail growth (mm) Day 5-7
Nail growth (mm) will be measured for each group
Measured: 5-7 days after polish application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start28 May 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will have all three nail types assessed: regular polish, gel polish and bare nail
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Geller, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05210920
- Sponsor's protocol ID
- 21-0027
- Acronym
- RBG
- Status last verified
- Aug 2023
- First submitted
- 12 Jan 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. PI may request authorship on shared data.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RBG: Regular, Bare, Gel: Does Type of Nail Polish Affect Bacterial Counts After Surgical Scrubbing?
- ClinicalTrials.gov ID
- NCT05210920
- Acronym / sponsor ID
- RBG / 21-0027
- Conditions
- Bacterial Infections, Surgical Site Infection, Contaminated Medical or Biological Substances
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 28 May 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 27 Jan 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.
Purpose: The purpose of this study is to evaluate if type of nail polish (gel polish or regular polish) has an effect on the number of bacterial colonies on finger nails after surgical scrubbing.
Participants: The potential participants are healthcare providers with patient interaction. Exclusion criteria include evidence of active dermatitis or other skin abnormalities, or allergy to chlorhexidine.
Intervention: Participants will have gel nail polish applied to one finger of their dominant hand, and regular polish applied to another finger of their dominant hand. Bacterial swabs will be collected from these two fingers, as well as the from the adjacent finger with no nail polish. Specimen collection will occur both before and after scrubbing with surgical soap. Bacterial counts will be compared between the three groups to determine the association between the presence of nail polish and nail polish type on bacterial counts after surgical scrubbing. Specimen collection will not take place during scrubbing for actual patient care.
Detailed description
Potential participants will be identified by word of mouth, flyers and institutional networking. Once a participant agrees to enroll, they will have each type of nail polish placed on a single finger on their dominant hand (gel on one finger and regular polish on another). A third finger will be left bare to serve as a control. On day 1-3 after nail polish application, the participant will have cotton swab samples taken from underneath their nail and over their nail bed, on each of the two polished nails, as well as the adjacent bare nail. These bacterial samples will be collected both before and after scrubbing (utilizing a nail pick, scrub brush, and chlorhexidine). This process will be repeat on day 5-7 after nail polish application. These samples will then be assessed for bacterial colonies in the Microbiology laboratory. Participant variables will be recorded in RedCap (scrubbing frequency, % of chipping in nails (in quartiles: 0, < 25%, < 50%, <75%, >75%, Gender, Age, Level of training, Specialty, Type of polish, Dominant hand, Duration since application of polish, Nail length in mm, Race, BMI, Type of bacteria isolated from samples).
Summary of Study Visits:
Day 0 Participants will have polish applied on two fingers on their dominant hand, one with gel polish and one with regular polish.
Day 1-3 The participants will return for their first swabs. Bacterial swabs will be obtained from the nail bed and under the fingernail of 3 fingers: the regular polish nail, the gel polish nail and a bare nail adjacent to the two polished nails, before and after a standard 5-minute scrub with chlorhexidine.
Day 5-7 The participants will return for the same procedure described above. The nail polish can be removed after this intervention. No further follow-up or involvement for participants
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants will have all three nail types assessed: regular polish, gel polish and bare nail
| Arm | Type | Receives |
|---|---|---|
| Regular Nail Polish | Experimental | Other: Nail polish applicationParticipants will have regular nail polish applied to one fingernail of their dominant hand |
| Gel Nail Polish | Experimental | Other: Nail polish applicationParticipants will have gel nail polish applied to one fingernail of their dominant hand |
| Bare Nail | No intervention | –Participants will have one fingernail of their dominant hand left bare for comparison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare provider who provides patient care
Key exclusion criteria (2 listed)
- Active dermatitis or other skin abnormality
- Allergy to chlorhexidine scrub soap
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 |
|---|---|---|
| Nail polish applicationAfter application of nail polish as described, participants will have bacterial swabs collected from the under the fingernail and from the nail bed of the three assigned fingers on their dominant hand, both before and after scrubbing with a chlorhexidine surgical scrubbing brush. | Other | Gel Nail Polish, Regular Nail Polish |
Primary outcome
Bacterial Counts Before Scrubbing Day 1-3
Time frame: 1-3 days after polish application
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Bacterial Counts After Scrubbing Day 1-3
Time frame: 1-3 days after polish application
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Bacterial Counts Before Scrubbing Day 5-7
Time frame: 5-7 days after polish application
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Bacterial Counts After Scrubbing Day 5-7
Time frame: 5-7 days after polish application
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
4 secondary outcomes
Percent of nail polish flaking (%) Day 1-3
Time frame: 1-3 days after polish application
Percent of nail polish flaking (%) Day 5-7
Time frame: 5-7 days after polish application
Nail growth (mm) Day 1-3
Time frame: 1-3 days after polish application
Nail growth (mm) Day 5-7
Time frame: 5-7 days after polish application
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 4 Aug 2023.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC. PI may request authorship on shared data.
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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.
Elizabeth Geller, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nail polish application in people with Bacterial Infections and Surgical Site Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 1 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: finished, as of the sponsor's last update on 4 Aug 2023. 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 United States. 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?
Bacterial Counts Before Scrubbing Day 1-3 (time frame: 1-3 days after polish application). 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 4 Aug 2023.