NCT04218110

Preoperative Skin Preparation Study to Evaluate the Antimicrobial Capabilities of Four Test Substances

Preoperative Skin Preparation Study Following ASTM E1173 Methods to Evaluate the Antimicrobial Capabilities of Four Test Substances

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Professional Disposables International, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Comparative study of antimicrobial effectiveness evaluation of of 26ml Project X, 10.5ml Project X, 5.1ml Project X and Prevantics Maxi swabstick following ASTM E1173 - Standard test method for evaluation of preoperative, precatheterization or preinjection skin preparations.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic	Application of antiseptic drug to the inguinal area of the subjects
DRUG	Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic	Application of antiseptic drug to the inguinal area of the subjects
DRUG	Isopropyl alcohol & Chlorhexidine Gluconate Antiseptic	Application of antiseptic drug to the inguinal area of the subjects
DRUG	Prevantics 3.15 % / 70 % Swabstick	Application of antiseptic drug to the inguinal area of the subjects

Timeline

• Start date: 2020-02-11
• Primary completion: 2020-03-10
• Completion: 2020-03-31
• First posted: 2020-01-06
• Last updated: 2021-10-22
• Results posted: 2021-10-22

Locations

1 site across 1 country: Romania

Regulatory

• FDA-regulated drug study