- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05181761
Prospective Nail Polish Study (Nail Polish)
Do Healthcare Personnel Wearing Non-chipped, Gel Nail Polish Harbor Increased Nail Bacterial Counts in Comparison to Healthcare Personnel Without Nail Polish
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Danville, Pennsylvania, United States, 17821
- Geisinger
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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))
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Left Hand with gel polish
The participants will receive gel nail polish on their left hand.
The right hand will remain natural (no gel polish)
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One hand of a subject with receive nail polish to compare bacterial growth between hands with gel nail polish to those without.
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Experimental: Right Hand with gel polish
The participants will receive gel nail polish on their right hand.
The left hand will remain natural (no gel polish).
|
One hand of a subject with receive nail polish to compare bacterial growth between hands with gel nail polish to those without.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of hand bacterial growth in natural nails and polished nails
Time Frame: 6 months
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To compare the rate of growth of bacteria found on the hands with natural nails versus nails with gel polish.
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6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rebecca Hoffman, MD, Geisinger Physician
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021-0810
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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