In-vivo Efficacy Study of Patient Preoperative Preps

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-01-31

Brief Summary

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The purpose of this study is to evaluate 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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Skin Flora Bacterial Reduction 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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3M CHG/IPA Prep Colorless

Applied 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 Colorless

Intervention Type DRUG

Apply topically.

3M CHG/IPA Prep Tint

Applied 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

Intervention Type DRUG

Apply topically.

ChloraPrep Hi-Lite Orange

Applied 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

Intervention Type DRUG

Apply topically.

Normal Saline

Applied 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

Saline

Intervention Type DRUG

Apply topically.

Interventions

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3M CHG/IPA Prep Colorless

Apply topically.

Intervention Type DRUG

3M CHG/IPA Prep Tint

Apply topically.

Intervention Type DRUG

ChloraPrep

Apply topically.

Intervention Type DRUG

Saline

Apply topically.

Intervention Type DRUG

Other Intervention Names

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Chlorhexidine glucontate and Isopropyl alcohol CHG 2% / IPA 70% Chlorhexidine gluconate 2% / Isopropyl alcohol 70% Chlorhexidine glucontate and Isopropyl alcohol CHG 2%/IPA 70% Chlorhexidine gluconate 2% / Isopropyl alcohol 70% ChloraPrep One-Step ChloraPrep Patient Preoperative Skin Preparation 2% CHG/70% IPA Chlorhexidine glucontate and Isopropyl alcohol Chlorhexidine gluconate 2% / Isopropyl alcohol 70% 0.9% NaCl Normal Saline

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