In Vivo Preoperative Skin Preparation Persistence Evaluation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-05

Study Completion Date

2017-04-25

Brief Summary

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Evaluate persistent antimicrobial effectiveness of chlorhexidine gluconate containing products on abdominal and inguinal sites following a saline and wipe challenge.

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Detailed Description

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Persistent antimicrobial effectiveness was evaluated by measuring the regrowth of normal skin flora at 48 hours, 72 hours and 96 hours, and the suppression of regrowth relative to post-prep (10-min) at 48 hours, 72 hours and 96 hours.

Conditions

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Bacterial Recovery of 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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3M CHG/IPA Prep

Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.

Group Type EXPERIMENTAL

3M CHG/IPA Prep

Intervention Type DRUG

Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

ChloraPrep

Apply topically for 30 seconds (abdominal site) or 2 minutes (inguinal site), and allow to dry for 3 minutes.

Group Type ACTIVE_COMPARATOR

ChloraPrep

Intervention Type DRUG

Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

Interventions

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3M CHG/IPA Prep

Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

Intervention Type DRUG

ChloraPrep

Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.

Intervention Type DRUG

Other Intervention Names

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Chlorhexidine Gluconate and Isopropyl Alcohol CHG/IPA Chlorhexidine Gluconate and Isopropyl Alcohol Chlorhexidine 2% / Isopropyl alcohol 70% CHG/IPA ChloraPrep One-Step

Eligibility Criteria

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Inclusion Criteria

* Subjects of any race
* Subjects in good 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 area
* 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