Test for Pre Operative Skin Preparations

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-13

Study Completion Date

2008-06-19

Brief Summary

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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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Detailed Description

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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.

Conditions

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Topical Antisepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CHG Swabstick (3 @ once)

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

3 swabsticks topically applied at the same time to intact skin

CHG Swabstick sequential

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Hibiclens

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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.

Sterile water swab (3 @ once)

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

Group Type PLACEBO_COMPARATOR

Sterile swabstick with sterile water (3 @ once)

Intervention Type OTHER

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

Sterile water swabstick (sequential)

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type OTHER

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

Interventions

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

3 swabsticks topically applied at the same time to intact skin

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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.

Intervention Type DRUG

Sterile swabstick with sterile water (3 @ once)

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

Intervention Type OTHER

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

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

Intervention Type OTHER

Other Intervention Names

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ChloraPrep Swabstick ChloraPrep Swabstick Hibiclens

Eligibility Criteria

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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.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes