In-vivo Efficacy of Patient Preoperative Prep

Zurex Pharma

Status and phase: Completed; Phase 3

Conditions: Surgical Skin Preparation

Treatments: Drug: ZP Vehicle; Drug: ChloraPrep; Drug: ZuraPrep

Study type: Interventional

Funder types: Industry

Identifiers

NCT02831998

ZX-ZP-0073 / 865-105

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

440 participants in 3 patient groups, including a placebo group

ZP (70% IPA)

Experimental group

Description:

Isopropyl alcohol (IPA) 70%

Treatment:

Drug: ZuraPrep

ChloraPrep

Active Comparator group

Description:

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

Treatment:

Drug: ChloraPrep

ZP Vehicle

Placebo Comparator group

Description:

ZP without IPA

Treatment:

Drug: ZP Vehicle