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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05210920
Other study ID # 21-0027
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 28, 2021
Est. completion date May 31, 2023

Study information

Verified date August 2023
Source University of North Carolina, Chapel Hill
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 53
Est. completion date May 31, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Healthcare provider who provides patient care Exclusion Criteria: - Active dermatitis or other skin abnormality - Allergy to chlorhexidine scrub soap

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Nail polish application
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.

Locations

Country Name City State
United States UNC Chapel Hill Chapel Hill North Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 1-3 days after polish application
Primary 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). 1-3 days after polish application
Primary 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). 5-7 days after polish application
Primary 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). 5-7 days after polish application
Secondary Percent of nail polish flaking (%) Day 1-3 Percent of nail polish flaking (%) will be measured for each type of polish 1-3 days after polish application
Secondary Percent of nail polish flaking (%) Day 5-7 Percent of nail polish flaking (%) will be measured for each type of polish 5-7 days after polish application
Secondary Nail growth (mm) Day 1-3 Nail growth (mm) will be measured for each group 1-3 days after polish application
Secondary Nail growth (mm) Day 5-7 Nail growth (mm) will be measured for each group 5-7 days after polish application
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