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

Primary Purpose

Bacterial Infections, Surgical Site Infection, Contaminated Medical or Biological Substances

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nail polish application
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bacterial Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthcare provider who provides patient care

Exclusion Criteria:

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

Sites / Locations

  • UNC Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Regular Nail Polish

Gel Nail Polish

Bare Nail

Arm Description

Participants will have regular nail polish applied to one fingernail of their dominant hand

Participants will have gel nail polish applied to one fingernail of their dominant hand

Participants will have one fingernail of their dominant hand left bare for comparison

Outcomes

Primary Outcome Measures

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).
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).
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).
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).

Secondary Outcome Measures

Percent of nail polish flaking (%) Day 1-3
Percent of nail polish flaking (%) will be measured for each type of polish
Percent of nail polish flaking (%) Day 5-7
Percent of nail polish flaking (%) will be measured for each type of polish
Nail growth (mm) Day 1-3
Nail growth (mm) will be measured for each group
Nail growth (mm) Day 5-7
Nail growth (mm) will be measured for each group

Full Information

First Posted
January 12, 2022
Last Updated
August 2, 2023
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT05210920
Brief Title
RBG: Regular, Bare, Gel: Does Type of Nail Polish Affect Bacterial Counts After Surgical Scrubbing?
Acronym
RBG
Official Title
RBG: Regular, Bare, Gel: Does Type of Nail Polish Affect Bacterial Counts After Surgical Scrubbing?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
May 28, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections, Surgical Site Infection, Contaminated Medical or Biological Substances

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All participants will have all three nail types assessed: regular polish, gel polish and bare nail
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regular Nail Polish
Arm Type
Experimental
Arm Description
Participants will have regular nail polish applied to one fingernail of their dominant hand
Arm Title
Gel Nail Polish
Arm Type
Experimental
Arm Description
Participants will have gel nail polish applied to one fingernail of their dominant hand
Arm Title
Bare Nail
Arm Type
No Intervention
Arm Description
Participants will have one fingernail of their dominant hand left bare for comparison
Intervention Type
Other
Intervention Name(s)
Nail polish application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bacterial Counts Before Scrubbing Day 1-3
Description
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Time Frame
1-3 days after polish application
Title
Bacterial Counts After Scrubbing Day 1-3
Description
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Time Frame
1-3 days after polish application
Title
Bacterial Counts Before Scrubbing Day 5-7
Description
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Time Frame
5-7 days after polish application
Title
Bacterial Counts After Scrubbing Day 5-7
Description
Bacterial colony counts will be measured from each swab obtained from the three types of fingernails (regular polish, gel polish, bare nail).
Time Frame
5-7 days after polish application
Secondary Outcome Measure Information:
Title
Percent of nail polish flaking (%) Day 1-3
Description
Percent of nail polish flaking (%) will be measured for each type of polish
Time Frame
1-3 days after polish application
Title
Percent of nail polish flaking (%) Day 5-7
Description
Percent of nail polish flaking (%) will be measured for each type of polish
Time Frame
5-7 days after polish application
Title
Nail growth (mm) Day 1-3
Description
Nail growth (mm) will be measured for each group
Time Frame
1-3 days after polish application
Title
Nail growth (mm) Day 5-7
Description
Nail growth (mm) will be measured for each group
Time Frame
5-7 days after polish application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthcare provider who provides patient care Exclusion Criteria: Active dermatitis or other skin abnormality Allergy to chlorhexidine scrub soap
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Geller, MD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
UNC Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

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

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