NCT03326726

Brief Summary

Medline 2% CHG cloth (Active) - A single cloth from the pack was used per treatment area. The investigational test article was applied topically by vigorously scrubbing the skin in a back and forth motion for three minutes (and halfway through the 3-minute application time, the cloth was turned over) over the treatment area (7" x 10" of the subject's back), and the skin was allowed to air dry.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2016

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
5.9 years until next milestone

Results Posted

Study results publicly available

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 days

First QC Date

October 23, 2017

Results QC Date

May 10, 2021

Last Update Submit

September 7, 2023

Conditions

Skin Coverage

Outcome Measures

Primary Outcomes (1)

  • Medline 2% CHG Cloth Dosage of Coverage Area

    To measure the dosage of the coverage area of a single investigational test article, Medline 2% CHG cloth calculated in grams per square centimeter

    3 minutes

Secondary Outcomes (1)

  • Post-application Drying Time

    Approximately 1 minute

Study Arms (1)

Chlorhexidine Gluconate

EXPERIMENTAL

2% CHG

Drug: 2% CHG

Interventions

2% CHGDRUG

Chlorhexidine Gluconate

Also known as: Medline 2% CHG cloth
Chlorhexidine Gluconate

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy males of at least 18 years of age having skin within 6 inches of the test regions that were free of tattoos, dermatoses, abrasions, cuts, lesions or other skin disorders, with no history of sensitivity to CHG and were able to lie prone for up to 30 minutes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Chromogranins

Intervention Hierarchy (Ancestors)

Nerve Tissue ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein Precursors

Results Point of Contact

Title
Sr. Regulatory Affairs Specialist
Organization
Medline Industries
aminarcik@medline.com
847-643-3515

Study Officials

  • Hamid Bashir

    Microbac Laboratories, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 31, 2017

Study Start

November 16, 2016

Primary Completion

November 18, 2016

Study Completion

November 18, 2016

Last Updated

September 28, 2023

Results First Posted

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share