In-vivo Efficacy of Patient Preoperative Prep

Surgical Skin Preparation Clinical Trial

Official title:

Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZP

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831998
• Other study ID #: ZX-ZP-0073 / 865-105
• Status: Completed
• Phase: Phase 3
• Start date: July 27, 2016
• Est. completion date: April 9, 2017

Study information

• Verified date: June 2021
• Source: Zurex Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to demonstrate the antimicrobial efficacy of the ZP Preoperative Prep on skin flora of the abdomen and inguinal regions of human subjects.

Description:

The purpose of this study is to evaluate the antimicrobial properties of one finished test product (ZP) with a positive control (CP) and a negative control (ZP™ Vehicle without IPA) when used as a patient preoperative skin preparation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: April 9, 2017
• Est. primary completion date: April 9, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects of any race
• Subjects in good health
• Minimum skin flora baseline requirements on abdomen and groin
• Skin free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorder near or on the applicable test area.

Exclusion Criteria:

• Topical or systemic antimicrobial exposure within 14 days prior to screening and treatment days, including antibiotics.
• Subjects with a history of skin sensitivity, skin allergies, or skin cancer.
• Subjects who are pregnant, attempting pregnancy or nursing.

Related Conditions & MeSH terms

• Surgical Skin Preparation

Intervention

Drug:
• ZuraPrep
Apply topically.
• ChloraPrep
Apply topically.
• ZP Vehicle
Apply topically.

Locations

Country	Name	City	State
United States	MicroBioTest Laboratories	Sterling	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Zurex Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacterial Reduction	A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success.	10 minutes post product application
Primary	Bacterial Reduction - Abdomen	A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success.	10 minutes post product application