NCT03224299

Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Objective of this study is to compare the antimicrobial properties of an investigational agent to an active control and a negative control when applied to specific body locations. Testing will be performed according to the procedures outlined in the Food and Drug Administration Tentative Final Monograph (TFM) for Effectiveness Testing of a Patient Preoperative Skin Preparation

Conditions

• Preoperative Skin Preparation

Interventions

Type	Name	Description
DRUG	OCT - clear	Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
DRUG	OCT- tinted	Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
OTHER	ChloraPrep	Active Control: ChloraPrep® - Hi-Lite Orange® applicator
OTHER	Saline	Negative Control: sterile 0.9% saline applied with single use applicator

Timeline

• Start date: 2017-06-21
• Primary completion: 2017-08-24
• Completion: 2017-10-03
• First posted: 2017-07-21
• Last updated: 2021-04-23
• Results posted: 2021-04-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study