NCT04035161

Evaluation of the Antimicrobial Effectiveness of CHG/IPA

Evaluation of the Antimicrobial Effectiveness of CHG/IPA in Healthy Volunteers

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 1,935 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This single site study is a randomized, controlled, partially-blinded design enrolling a minimum of 516 healthy volunteers, where each subject will receive two of the planned study products on the product application sites of the abdomen and/or groin.

Detailed description

To demonstrate the antimicrobial activity of the Investigational Product (IP) by comparing counts of resident skin microbes, obtained after IP application to intact skin of the abdomen and groin, to counts obtained prior to application.

Conditions

• Microbial Colonization

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Investigational Product	2%(w/v) Chlorhexidine in 70%(v/v) Isopropyl skin preparation
OTHER	Reference Standard	60% (v/v) 1-propanol skin preparation
COMBINATION_PRODUCT	Active Comparator	ChloraPrep® SEPP® skin preparation
OTHER	Negative Control	0.9% Normal Saline skin preparation

Timeline

• Start date: 2019-04-17
• Primary completion: 2019-12-24
• Completion: 2019-12-24
• First posted: 2019-07-29
• Last updated: 2021-08-17
• Results posted: 2021-08-17

Locations

1 site across 1 country: Romania