Clinical Evaluation of Patient Preoperative Prep

• Status: Completed
• Trial end date: 2017-08-03
• Target enrollment: 0
• Participant gender: All

Summary

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.

• 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 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.