Clinical Evaluation of Patient Preoperative Prep

Zurex Pharma

Status and phase: Completed; Phase 3

Conditions: Surgical Skin Preparation

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02831816

ZX-ZP-0074 / 150316-103

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.

Enrollment: 640 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

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640 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