NCT00636480

Preoperative Skin Preparation Evaluation

Preoperative Skin Preparation Evaluation of One Test Product With a Positive and a Negative Control

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA.

Detailed description

Determine the antimicrobial properties of a proposed new product and an already approved product and a placebo (no drug). Study will be conducted using methods dictated by the FDA. This study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with the proposed new product, the currently approved product and the placebo.

Conditions

• Topical Antisepsis

Interventions

Type	Name	Description
DRUG	Chlorhexidine gluconate	Chlorhexidine gluconate (2% w/v) in an aqueous base, 26 ml applicator. Active drug contains alcohol and the placebo contains no drug. Administered topically.
DRUG	ChloraPrep One Step	Administer topically
DRUG	Sterile saline	0.9% NaCl solution

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-03-14
• Last updated: 2025-11-26

Locations

1 site across 1 country: United States