Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-30 @ 4:45 PM
Study NCT ID:
NCT03782103
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)
Sponsor:
Zurex Pharma, Inc.
Organization:
Study Overview
Official Title:
Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZP
Brief Summary:
The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.
Detailed Description:
The primary objective of this study is to measure the antimicrobial effectiveness of a single investigational test article, ZuraPrep™ as specified by the Healthcare Antiseptics, Topical Antimicrobial Drug Products Final Rule of December 20, 2017. The treatments will be ZuraPrep™ as the investigational test article, ChloraPrep® as an active control, and ZuraPrep™ Vehicle as a negative control. For efficacy at 30 seconds post-prep, the test article should be superior to the negative control using a margin of 1.2 log10 CFU/cm2 and non-inferior to the active control using a margin of 0.5 log10 CFU/cm2.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: