In-vivo Efficacy Study of Patient Pre-operative Preps

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

426 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to determine the antimicrobial efficacy of the 3M CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

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Detailed Description

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The primary efficacy is evaluated by demonstration that the product provides a lower bound of the 95% confidence interval of percent responders that is greater than or equal to 70%.

On the abdominal sites, a responder is defined as a subject with a 2-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal sites, a responder is defined as a subject with a 3-log10 per cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

Conditions

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Bacterial Reduction on Skin Flora Post-product Application

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ChloraPrep Hi-Lite Orange

Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Group Type ACTIVE_COMPARATOR

ChloraPrep Hi-Lite Orange

Intervention Type DRUG

Apply topically.

Normal Saline

Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Apply topically.

3M CHG/IPA Prep Tint 10.5 mL

Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Group Type EXPERIMENTAL

3M CHG/IPA Prep Tint 10.5-mL

Intervention Type DRUG

Apply topically.

3M CHG/IPA Prep Tint 26-mL

Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.

Group Type EXPERIMENTAL

3M CHG/IPA Prep Tint 26-mL

Intervention Type DRUG

Apply topically

Interventions

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ChloraPrep Hi-Lite Orange

Apply topically.

Intervention Type DRUG

Normal saline

Apply topically.

Intervention Type DRUG

3M CHG/IPA Prep Tint 10.5-mL

Apply topically.

Intervention Type DRUG

3M CHG/IPA Prep Tint 26-mL

Apply topically

Intervention Type DRUG

Other Intervention Names

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ChloraPrep One-Step Chlorhexidine gluconate 2% / Isopropyl alcohol 70% Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v 2% CHG / 70% IPA ChloraPrep Chlorhexidine Gluconate and Isopropyl alcohol 0.9% Sodium Chloride Sterile Saline 0.9% NaCl Saline Chlorhexidine Gluconate and Isopropyl Alcohol Chlorhexidine gluconate 2% / Isopropyl alcohol 70% Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v 2% CHG / 70% IPA Chlorhexidine Gluconate and Isopropyl Alcohol Chlorhexidine gluconate 2% / Isopropyl alcohol 70% Chlorhexidine gluconate 2% w/v / Isopropyl alcohol 70% v/v 2% CHG / 70% IPA

Eligibility Criteria

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Inclusion Criteria

* Subjects of any race
* Subjects in good general health
* Minimum skin flora baseline requirements on abdomen and groin

Exclusion Criteria

* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes