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Completed

NCT Number: NCT00799812

Test for Pre Operative Skin Preparations

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.

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Key information

Conditions

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Microbiotest

Sterling, Virginia, 20164, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must read and sign an Informed Consent Form and be cooperative.
  • Subjects must be in good general health.
  • Subjects must have skin within 6 inches of the test site that is free of tattoos, dermatoses, abrasions, cuts, lesions, or other skin disorders.

Exclusion criteria

  • Use of systemic or topical antimicrobials during the 2-week pretest conditioning period. This restriction includes but is not limited to shampoos, lotions, soaps, baby powders, and materials, such as solvents, acids, or alkalis.
  • A medical diagnosis of a physical condition, which would preclude participation such as: diabetes, hepatitis, an organ transplant, a medical surgical implant, or an immunocompromised system.
  • Any medical condition that in the opinion of the investigator would preclude participation.
  • Bathed in chemically treated pools or hot tubs 2 weeks prior to any microbial sampling.
  • Used UV tanning lamps 2 weeks prior to any microbial sampling.
  • Bathing or showering less than 48 hours prior to any microbial sampling.
  • Known sensitivity to chlorhexidine gluconate.
  • Known sensitivity to latex (rubber).
  • Known sensitivity to fragrances.
  • Pregnant or nursing.
  • Unwillingness to fulfill the performance requirements of the study.
  • Subjects who have completed part or all of the study will not be reentered in the study.

Treatment and study plan

CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).

Drug

3 swabsticks topically applied at the same time to intact skin

Other names: ChloraPrep Swabstick

CHG 2% w/v & IPA 70% v/v swab applied sequentially

Drug

Chlorhexidine gluconate 2% w/v and isopropyl alcohol 70% v/v; 3 swabsticks applied sequentially to intact skin.

Other names: ChloraPrep Swabstick

Aqueous CHG 4% w/v applied according to mfr's directions

Drug

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 names: Hibiclens

Sterile swabstick with sterile water (3 @ once)

Other

3 sterile swabsticks wetted with sterile water topically applied to intact skin at the same time.

Sterile swabstick with sterile water (one-at-a-time)

Other

Sterile swabsticks wetted with sterile water topically applied to intact skin one-at-a-time.

Primary outcomes

  1. log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites

    Time frame: 10 minutes and 6 hours after application of test solutions

    The bacterial reductions achieved by the test products and the controls using 2 different application techniques at 10-minute and 6-hour sampling intervals for both groin and abdominal sites were evaluated.

Sponsors and collaborators

Lead sponsor

C. R. Bard

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Dec 1, 2008
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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