Bacterial GrowthNail PolishNCT05181761
Prospective Nail Polish Study
A study testing Gel Polish in people with Bacterial Growth, run by Geisinger Clinic at 1 site in United States.
Trial summary
This is an randomized, prospective study utilizing volunteers from the anesthesia department at Geisinger Medical Center (GMC). Subjects' hands will be randomized 1:1 using statistical software to determine which hand will receive the gel polish using proportional stratified random sampling. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Bacterial Growth
- What is being tested?
- Gel Polish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2022to 24 Mar 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Geisinger employee
- ≥18 years of age
- Able and willing to provide consent
- Works as a Anesthesiologists, Anesthesia resident physicians or Certified Registered Nurse Anesthetists (CRNA))
Who cannot join
- Hospital employees in the anesthesia department that are not involved in direct patient contact (Anesthesia Technicians).
- Hospital employees that are under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Healthcare Personnel Wearing Non-chipped, Gel Nail Polish Harbor Increased Nail Bacterial Counts in Comparison to Healthcare Personnel Without Nail Polish
This is an randomized, prospective study utilizing volunteers from the anesthesia department at Geisinger Medical Center (GMC). Subjects' hands will be randomized 1:1 using statistical software to determine which hand will receive the gel polish using proportional stratified random sampling. The glove juice method will be used to measure hand bacterial counts to determine whether or not hands with nail polish harbor more bacteria than hands without polish. In addition, all subjects will fill out an employee satisfaction survey related to their satisfaction at work at the beginning of the study as well as at the end of the study.
Read the detailed description
The study is recruiting Geisinger employees who are 18 years old that work as Anesthesiologists, Anesthesia resident physicians, Certified Registered Nurse Anesthetists (CRNA) in the anesthesia department involved in direct patient care. The study duration will be one month (30 days). On day zero, participants' baseline hand bacteria counts will be measured for each hand via the glove juice method. Subsequently, after participants' hands have been randomized into the painted and unpainted groups, they will receive a manicure on either their left or right hand. In other words, if a patient's left hand is randomized into the painted group, then that hand will be painted, and the right hand will be left unpainted, and vice versa. All participants will then be seen on days 1, 7, 14, 21, and 28 to have both hand's bacterial counts measured.
On study day zero, all subjects will meet at a designated Geisinger Medical Center location and will be asked to fill out a work satisfaction survey. Then, before the subjects' hands are randomized into painted and unpainted groups, each of their hands' baseline bacteria counts will be measured using the glove juice method.
Measuring hand bacteria counts with the glove juice method:
Prior to performing the glove juice method to obtain hand bacteria counts, participants will be asked to wash their hands with soap and water. Participants will then place their hands into regular, non-sterile gloves. The premade broth for the glove juice method will then be placed into both gloves. The study group administrators will then place an elastic around both subject's wrists so that the juice does not spill out of the gloves. Hands will be gently massaged for one minute. Then, for each gloved hand, a pipet will remove some of the juice and this will be sent to the laboratory to determine the juice bacterial counts (log10CFU). The bacterial counts will be recorded on that particular subject's Bacterial count form and later entered into REDCap. After recording the specimens will be discarded.
All subjects will then return on days 1, 7, 14, 21, and 28. The study administrators will directly record whether or not there are any chips on the nails of the hands in the nail polish group and record their findings on the subject's bacterial count sheet. All subjects will have the glove juice method previously described performed again. Juice specimens obtained on each date will be sent to the laboratory and bacterial counts recorded on the bacterial count sheet and later entered into REDCap.
- Conditions
- Bacterial Growth
- Being tested
- Gel Polish
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gel PolishOther
One hand of a subject with receive nail polish to compare bacterial growth between hands with gel nail polish to those without.
| Study group | Role | What they receive |
|---|---|---|
| Left Hand with gel polish | Experimental | The participants will receive gel nail polish on their left hand. The right hand will remain natural (no gel polish) Receives: Other: Gel Polish |
| Right Hand with gel polish | Experimental | The participants will receive gel nail polish on their right hand. The left hand will remain natural (no gel polish). Receives: Other: Gel Polish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of hand bacterial growth in natural nails and polished nails
To compare the rate of growth of bacteria found on the hands with natural nails versus nails with gel polish.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start11 Sep 2022
- Primary completion21 Nov 2022
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial GrowthStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Hoffman, MD, Principal investigator, Geisinger Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05181761
- Sponsor's protocol ID
- 2021-0810
- Acronym
- Nail Polish
- Status last verified
- Aug 2024
- First submitted
- 20 Dec 2021
- Last updated
- 22 Aug 2024
- 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Healthcare Personnel Wearing Non-chipped, Gel Nail Polish Harbor Increased Nail Bacterial Counts in Comparison to Healthcare Personnel Without Nail Polish
- ClinicalTrials.gov ID
- NCT05181761
- Acronym / sponsor ID
- Nail Polish / 2021-0810
- Conditions
- Bacterial Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Study start
- 11 Sep 2022 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 6 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.
This is an randomized, prospective study utilizing volunteers from the anesthesia department at Geisinger Medical Center (GMC). Subjects' hands will be randomized 1:1 using statistical software to determine which hand will receive the gel polish using proportional stratified random sampling. The glove juice method will be used to measure hand bacterial counts to determine whether or not hands with nail polish harbor more bacteria than hands without polish. In addition, all subjects will fill out an employee satisfaction survey related to their satisfaction at work at the beginning of the study as well as at the end of the study.
Detailed description
The study is recruiting Geisinger employees who are 18 years old that work as Anesthesiologists, Anesthesia resident physicians, Certified Registered Nurse Anesthetists (CRNA) in the anesthesia department involved in direct patient care. The study duration will be one month (30 days). On day zero, participants' baseline hand bacteria counts will be measured for each hand via the glove juice method. Subsequently, after participants' hands have been randomized into the painted and unpainted groups, they will receive a manicure on either their left or right hand. In other words, if a patient's left hand is randomized into the painted group, then that hand will be painted, and the right hand will be left unpainted, and vice versa. All participants will then be seen on days 1, 7, 14, 21, and 28 to have both hand's bacterial counts measured.
On study day zero, all subjects will meet at a designated Geisinger Medical Center location and will be asked to fill out a work satisfaction survey. Then, before the subjects' hands are randomized into painted and unpainted groups, each of their hands' baseline bacteria counts will be measured using the glove juice method.
Measuring hand bacteria counts with the glove juice method:
Prior to performing the glove juice method to obtain hand bacteria counts, participants will be asked to wash their hands with soap and water. Participants will then place their hands into regular, non-sterile gloves. The premade broth for the glove juice method will then be placed into both gloves. The study group administrators will then place an elastic around both subject's wrists so that the juice does not spill out of the gloves. Hands will be gently massaged for one minute. Then, for each gloved hand, a pipet will remove some of the juice and this will be sent to the laboratory to determine the juice bacterial counts (log10CFU). The bacterial counts will be recorded on that particular subject's Bacterial count form and later entered into REDCap. After recording the specimens will be discarded.
All subjects will then return on days 1, 7, 14, 21, and 28. The study administrators will directly record whether or not there are any chips on the nails of the hands in the nail polish group and record their findings on the subject's bacterial count sheet. All subjects will have the glove juice method previously described performed again. Juice specimens obtained on each date will be sent to the laboratory and bacterial counts recorded on the bacterial count sheet and later entered into REDCap.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Left Hand with gel polish | Experimental | Other: Gel PolishThe participants will receive gel nail polish on their left hand. The right hand will remain natural (no gel polish) |
| Right Hand with gel polish | Experimental | Other: Gel PolishThe participants will receive gel nail polish on their right hand. The left hand will remain natural (no gel polish). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Geisinger employee
- ≥18 years of age
- Able and willing to provide consent
- Works as a Anesthesiologists, Anesthesia resident physicians or Certified Registered Nurse Anesthetists (CRNA))
Key exclusion criteria (2 listed)
- Hospital employees in the anesthesia department that are not involved in direct patient contact (Anesthesia Technicians).
- Hospital employees that are under 18 years of age
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 |
|---|---|---|
| Gel PolishOne hand of a subject with receive nail polish to compare bacterial growth between hands with gel nail polish to those without. | Other | Left Hand with gel polish, Right Hand with gel polish |
Primary outcome
Rate of hand bacterial growth in natural nails and polished nails
Time frame: 6 months
To compare the rate of growth of bacteria found on the hands with natural nails versus nails with gel polish.
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 22 Aug 2024.
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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.
Rebecca Hoffman, MD principal investigator
Geisinger Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gel Polish in people with Bacterial Growth, run by Geisinger Clinic 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 4 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 22 Aug 2024. 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?
Rate of hand bacterial growth in natural nails and polished nails (time frame: 6 months). 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 22 Aug 2024.