Status:
COMPLETED
In-vivo Efficacy of Patient Preoperative Prep, ZuraPrep (ZP)
Lead Sponsor:
Zurex Pharma, Inc.
Conditions:
Surgical Skin Preparation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2019
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03782103
Start Date
January 25 2019
End Date
September 26 2019
Last Update
February 8 2023
Active Locations (1)
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1
Microbac Laboratories, Inc.
Sterling, Virginia, United States, 20164