NCT00799812

Test for Pre Operative Skin Preparations

Test for Pre Operative Skin Preparations: ChloraPrep Triple Swabsticks, Hibiclens and Sterile Triple Swabsticks (Using Sterile Deionized Water)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 335 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions. Sterile swabsticks (wetted with sterile deionizd water) applied using the same method as the ChloraPrep Swabstick.

Detailed description

Determine differences (if any) in 2 different application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens, a liquid antibacterial soap, applied according to the manufacturer's directions as a active/positive comparison. Sterile swabsticks (wetted with sterile deionized water) applied as a negative comparison using the same method as the ChloraPrep swabstick. Study uses topical sampling from the abdomen and the groin on intact skin and evaluates the germs left on the skin after treatment with ChloraPrep Swabsticks.

Conditions

• Topical Antisepsis

Interventions

Type	Name	Description
DRUG	CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).	3 swabsticks topically applied at the same time to intact skin
DRUG	CHG 2% w/v & IPA 70% v/v swab applied sequentially	Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.
DRUG	Aqueous CHG 4% w/v applied according to mfr's directions	Chlorhexidine gluconate 4% w/v in an aqueous base applied according to mfr's directions. Step 1) 5 ml of Hibiclens applied to a sterile gauze pad. Step 2) Product applied to treatment area on intact skin for 2 minutes. Area dried with sterile towel or sterile gauze. Steps 1 and 2 repeated.
OTHER	Sterile swabstick with sterile water (3 @ once)	3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.
OTHER	Sterile swabstick with sterile water (one-at-a-time)	Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.

Timeline

• Start date: 2007-11-13
• Primary completion: 2008-04-27
• Completion: 2008-06-19
• First posted: 2008-12-01
• Last updated: 2025-12-11
• Results posted: 2021-05-27

Locations

1 site across 1 country: United States