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

Clinical Evaluation of the Antimicrobial Effectiveness of Topically Applied ZuraPrep

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.

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.

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.