Clinical trial NCT00799812: Test for Pre Operative Skin Preparations
Official title: Test for Pre Operative Skin Preparations: ChloraPrep Triple Swabsticks, Hibiclens and Sterile Triple Swabsticks (Using Sterile Deionized Water)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Topical Antisepsis
Keywords: antimicrobial
antisepsis
Lead sponsor: CareFusion
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 335
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: log10 Reductions From Baseline for Each Test Parameter in CFU (Colony Forming Unit)/cm2 on Inguinal and Abdominal Sites
timeFrame: 10 minutes and 6 hours after application of test solutions
Secondary outcomes:
Other outcomes:
Locations:
city: Sterling
country: United States
facility: Microbiotest
state: Virginia
Study officials:
affiliation: Medical Director
name: M. Hamid Bashir, MD
role: PRINCIPAL_INVESTIGATOR
References: