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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • Geisinger

    Danville, Pennsylvania, 17821

Other trials in United States

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.

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 groups in NCT05181761
Study groupRoleWhat they receive
Left Hand with gel polishExperimentalThe 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 polishExperimentalThe 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.

  1. 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.

  1. First posted6 Jan 2022
  2. Study start11 Sep 2022
  3. Primary completion21 Nov 2022
  4. Study completion24 Mar 2023

Resources

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)
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

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.

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