In Vivo Patient Preoperative Skin Prep Persistence

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-04-30

Brief Summary

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The objective of the study is to demonstrate persistence of the 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 objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.

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 - Abdominal Region

Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.

Group Type EXPERIMENTAL

3M CHG/IPA Surgical Skin Preparation - Abdominal Region

Intervention Type DRUG

Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Normal Saline - Abdominal Region

Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.

Group Type PLACEBO_COMPARATOR

Normal Saline - Abdominal Region

Intervention Type OTHER

0.9% sodium chloride applied with foam applicator

3M CHG/IPA - Inguinal Region

Apply Chlorhexidine (CHG) 2% / Isopropyl alcohol (IPA) 70% for 30 seconds and allow to dry for 3 minutes.

Group Type EXPERIMENTAL

3M CHG/IPA Surgical Skin Preparation - Inguinal Region

Intervention Type DRUG

Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Normal Saline - Inguinal Region

Apply 0.9% sodium chloride with applicator for 30 seconds and allow to dry for 3 minutes.

Group Type PLACEBO_COMPARATOR

Normal Saline - Inguinal Region

Intervention Type OTHER

0.9% sodium chloride applied with foam applicator

Interventions

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3M CHG/IPA Surgical Skin Preparation - Abdominal Region

Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Intervention Type DRUG

Normal Saline - Abdominal Region

0.9% sodium chloride applied with foam applicator

Intervention Type OTHER

3M CHG/IPA Surgical Skin Preparation - Inguinal Region

Chlorhexidine gluconate 2% / Isopropyl alcohol 70%

Intervention Type DRUG

Normal Saline - Inguinal Region

0.9% sodium chloride applied with foam applicator

Intervention Type OTHER

Other Intervention Names

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SoluPrep SoluPrep

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