NCT03861780

Pilot Evaluation of Two Test Materials With a Positive Control When Used as a Patient Preoperative Skin Preparation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Professional Disposables International, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Comparative Study of Antimicrobial Effectiveness Evaluation of 26ml 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, ASTM International, West Conshohocken, Pennsylvania, 2015

Conditions

• Bacteria Microflora Reduction

Interventions

Type	Name	Description
DRUG	Project X 26ml	Application of antiseptic drug to the inguinal and abdomen areas of the subjects
DRUG	Project X 5.1ml	Application of antiseptic drug to the inguinal and abdomen areas of the subjects
DRUG	Prevantics Maxi Swabstick	Application of antiseptic drug to the inguinal and abdomen areas of the subjects

Timeline

• Start date: 2019-04-02
• Primary completion: 2019-06-06
• Completion: 2019-06-06
• First posted: 2019-03-04
• Last updated: 2021-10-22
• Results posted: 2021-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study