Antimicrobial Efficacy of 2% CHG (Chlorhexidine Gluconate)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CHG

• Registration Number: NCT02530541
• Lead Sponsor: Medline Industries

Brief Summary

Pilot study to evaluate and compare activity of preoperative preparation with comparator

Detailed Description

Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using TFM criteria.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2014-07
• Study Completion: 2015-05
• Study First Submitted: 2015-08-16
• Study First Submitted QC: 2015-08-19
• Study First Posted: 2015-08-21
• Results First Submitted: 2015-11-25
• Status Verified: 2020-09
• Results First Submitted QC: 2021-04-29
• Last Update Submitted: 2021-04-29
• Results First Posted: 2021-04-30
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Healthy
• No dermatological conditions

Exclusion Criteria

• Sensitivity to CHG
• Sensitivity to natural latex rubber or adhesive skin products

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHG 1 min	CHG	1 min application time
CHG 2 min	CHG	2 min application time
Comparator CHG	CHG	Marketed CHG

Primary Outcome Measures

Name	Time	Method
Log Reduction of Bacterial Flora on the Abdomen and Groin	10 min, 6 hr and 8 hr	Evaluate the Log Reduction of normal flora at various timepoints.