In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)

Surgical Skin Preparation Clinical Trial

— ZP  

Official title:

Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03782103
• Other study ID #: ZX-ZP-0092 / 865-107
• Status: Completed
• Phase: Phase 3
• Start date: January 25, 2019
• Est. completion date: September 26, 2019

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 Zurex Preoperative Prep (ZuraPrep - clear) on skin flora of the abdomen and inguinal regions of human subjects.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: September 26, 2019
• Est. primary completion date: May 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects of any race
• Subjects in good general health
• Minimum bacterial 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.
• Taking antihistamines, immunosuppressants, or oral steroids within 14 days prior to screening and treatment days, excluding contraception or post-menopausal treatment.
• Subjects with allergies to study materials including isopropyl alcohol or chlorhexidine gluconate.
• 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 Clear Solution
Apply topically.
• ChloraPrep
Apply topically.
• ZuraPrep Vehicle
Apply topically.

Locations

Country	Name	City	State
United States	Microbac Laboratories, Inc.	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 - Groin	A 3-log10 CFU/cm^2 bacterial reduction on the inguinal region is considered a success.	30 seconds post product application
Primary	Bacterial Reduction - Abdomen	A 2-log10 CFU/cm^2 bacterial reduction on the abdomen region is considered a success.	30 seconds post product application
Secondary	Bacterial Counts Not Exceeding Baseline in the Abdomen and Groin Region	Bacterial counts should not exceed baseline on the abdomen or groin region	6 hours post product applcation