Test for Pre Operative Skin Preparations

• Status: Completed
• Trial end date: 2008-06-19
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CareFusion
• Treatments: Chlorhexidine; Chlorhexidine gluconate

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.