NCT05210920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 28, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

August 4, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

January 12, 2022

Last Update Submit

August 2, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Percent of nail polish flaking (%) Day 1-3

    1-3 days after polish application

  • Percent of nail polish flaking (%) Day 5-7

    5-7 days after polish application

  • Nail growth (mm) Day 1-3

    1-3 days after polish application

  • Nail growth (mm) Day 5-7

    5-7 days after polish application

Study Arms (3)

Regular Nail Polish

EXPERIMENTAL

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

Other: Nail polish application

Gel Nail Polish

EXPERIMENTAL

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

Other: Nail polish application

Bare Nail

NO INTERVENTION

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

Interventions

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.

Gel Nail PolishRegular Nail Polish

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthcare provider who provides patient care

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27516, United States

Location

MeSH Terms

Conditions

Bacterial InfectionsSurgical Wound Infection

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsWound InfectionPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Elizabeth Geller, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: All participants will have all three nail types assessed: regular polish, gel polish and bare nail
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 27, 2022

Study Start

May 28, 2021

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

August 4, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

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.

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

Locations