Test for Pre Operative Skin Preparations

C. R. Bard

Status and phase: Completed; Phase 3

Conditions: Topical Antisepsis

Treatments: Drug: Aqueous CHG 4% w/v applied according to mfr's directions; Other: Sterile swabstick with sterile water (3 @ once); Drug: CHG 2% w/v & IPA 70% v/v swab applied sequentially; Drug: CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once).; Other: Sterile swabstick with sterile water (one-at-a-time)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00799812

ENT 371-121

Details and patient eligibility

About

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.

Full 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.

Enrollment: 335 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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335 participants in 5 patient groups, including a placebo group

CHG Swabstick (3 @ once)

Experimental group

Description:

Chlorhexidine gluconate (CHG) 2% w/v CHG/isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied @ same time

Treatment:

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

CHG Swabstick sequential

Experimental group

Description:

Chlorhexidine gluconate (CHG) 2% w/v and isopropyl alcohol (IPA) 70% v/v - 3 swabsticks applied sequentially

Treatment:

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

Hibiclens

Active Comparator group

Description:

Chlorhexidine gluconate (CHG) 4% w/v in an aqueous base

Treatment:

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

Sterile water swab (3 @ once)

Placebo Comparator group

Description:

Sterile swabstick wetted with sterile deionized water - 3 swabsticks applied at the same time.

Treatment:

Other: Sterile swabstick with sterile water (3 @ once)

Sterile water swabstick (sequential)

Placebo Comparator group

Description:

Sterile swabstick wetted with sterile water--3 swabsticks applied sequentially.

Treatment:

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