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

Zurex Pharma

Status and phase: Completed; Phase 3

Conditions: Surgical Skin Preparation

Treatments: Drug: ZuraPrep Clear Solution; Drug: ChloraPrep; Drug: ZuraPrep Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT03782103

ZX-ZP-0092 / 865-107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 3 patient groups, including a placebo group

ZuraPrep (70% IPA)

Experimental group

Description:

Isopropyl alcohol (IPA) 70%

Treatment:

Drug: ZuraPrep Clear Solution

ChloraPrep

Active Comparator group

Description:

Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70%

Treatment:

Drug: ChloraPrep

ZuraPrep Vehicle

Placebo Comparator group

Description:

Zurex Prep without IPA

Treatment:

Drug: ZuraPrep Vehicle