RBG: Regular, Bare, Gel: Does Type of Nail Polish Affect Bacterial Counts After Surgical Scrubbing? (RBG)

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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections; Surgical Site Infection; Contaminated Medical or Biological Substances
• Intervention / Treatment: Other: Nail polish application

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27516
      • UNC Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthcare provider who provides patient care

Exclusion Criteria:

• Active dermatitis or other skin abnormality
• Allergy to chlorhexidine scrub soap

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regular Nail Polish; Participants will have regular nail polish applied to one fingernail of their dominant hand	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.
Experimental: Gel Nail Polish; Participants will have gel nail polish applied to one fingernail of their dominant hand	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.
No Intervention: Bare Nail; Participants will have one fingernail of their dominant hand left bare for comparison

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Nail growth (mm) Day 1-3	Nail growth (mm) will be measured for each group	1-3 days after polish application
Nail growth (mm) Day 5-7	Nail growth (mm) will be measured for each group	5-7 days after polish application

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Investigators: Principal Investigator: Elizabeth Geller, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Disease Attributes; Bacterial Infections and Mycoses; Wound Infection; Infections; Communicable Diseases; Surgical Wound Infection; Bacterial Infections
• Other Study ID Numbers: 21-0027

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication, provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

PI may request authorship on shared data.

• IPD Sharing Time Frame: The data will be available beginning 12 mos following publication and ending 24 months after publication.
• IPD Sharing Access Criteria: Following approval from an appropriate review board as described above and execution of a data use/sharing agreement with UNC-Chapel Hill

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No