Test for Pre Operative Skin Preparations

C. R. Bard335 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

335

Conditions

Topical Antisepsis

Interventions

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

3 swabsticks topically applied at the same time to intact skin

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

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

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

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.

Eligibility

Sex: ALLMin age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Microbiotest

Sterling, Virginia, United States

Outcomes

Primary Outcomes

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

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.

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

Data from ClinicalTrials.gov

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