Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05181761 |
| Other study ID # |
2021-0810 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 11, 2022 |
| Est. completion date |
March 24, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Geisinger Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
