Evaluation 2% Chlorhexidine Gluconate

Evaluation of the Area Covered by Medline 2% Chlorhexidine Gluconate Cloth Preoperative Skin Preparation

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.

Study Overview

• Status: Completed
• Conditions: Skin Coverage
• Intervention / Treatment: Drug: 2% CHG

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine Gluconate; 2% CHG	Drug: 2% CHG; Chlorhexidine Gluconate; Other Names: Medline 2% CHG cloth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-application Drying Time	To assess post-application drying time after a single dose topical application of Medline 2% CHG cloth. Drying time is defined as when the entire treatment area appears visibly dry.	Approximately 1 minute

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related skin irritation scores and the incidence of adverse events reported during the study.	A corresponding rating score for each individual skin condition, for each site will be recorded, which includes the following four independent evaluation categories: Erythema, Edema, Rash, and Dryness.	2 days

Collaborators and Investigators

• Sponsor: Medline Industries
• Investigators: Principal Investigator: Hamid Bashir, Microbac Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2016
• Primary Completion (Actual): November 18, 2016
• Study Completion (Actual): November 18, 2016

Study Registration Dates

• First Submitted: October 23, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: R16-034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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