Test for Pre Operative Skin Preparations
NCT00799812 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 335
Last updated 2025-12-11
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.
Conditions
- Topical Antisepsis
Interventions
- 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.
Sponsors & Collaborators
-
C. R. Bard
lead INDUSTRY
Principal Investigators
-
M. Hamid Bashir, MD · Medical Director
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 16 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2007-11-13
- Primary Completion
- 2008-04-27
- Completion
- 2008-06-19
Countries
- United States
Study Locations
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