In-vivo Efficacy of Patient Preoperative Prep

• Status: Completed
• Trial end date: 2019-09-26
• Target enrollment: 0
• Participant gender: All

Summary

The objective of the study is to demonstrate the antimicrobial efficacy of the Zurex Preoperative Prep (ZG - clear) on skin flora of the abdomen and inguinal regions of human subjects.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zurex Pharma, Inc.
• Treatments: Chlorhexidine; Chlorhexidine gluconate; Ethanol

Criteria

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.