In-vivo Efficacy Study of Patient Pre-operative Preps

Phase 3

Completed

Interventions: Drug: Normal saline
Drug: 3M CHG/IPA Prep Tint 10.5-mL
Drug: 3M CHG/IPA Prep Tint 26-mL
Drug: ChloraPrep Hi-Lite Orange

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Normal Saline	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.
3M CHG/IPA Prep Tint 10.5 mL	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.
3M CHG/IPA Prep Tint 26-mL	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.
ChloraPrep Hi-Lite Orange	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.

Primary Outcome Measures

Name	Time	Method
Responder Rate	baseline, 10 minutes post-product application and 6 hour post-product application	On the abdominal region a responder was a subject with a 2 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline. On the inguinal region a responder was a subject with a 3 log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora did not return to baseline.

Secondary Outcome Measures

Name	Time	Method
Reduction of Skin Flora 10 Minutes Post-treatment	10 minutes	log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 10 minutes post-treatment
Safety as Assessed by Skin Irritation (Dryness, Edema, Erythema, Rash) Rating Score	Assessed at baseline (pre-treatment) and 10 minute post-treatment and 6 hour post-treatment.	Skin irritation (dryness, edema, erythema, rash) assessed on the test sites using a 0-3 rating scale: 0=no reaction, 1=mild, 2=moderated, 3=severe
Skin Flora Baseline for the Abdominal and Inguinal Region.	Baseline	Log10/cm2 baseline skin flora for abdominal and inguinal regions
Reduction of Skin Flora 6 Hours Post-treatment	6 hours	log10/cm2 reduction of skin flora, relative to treatment day baseline (log10/cm2), at 6 hours post-treatment
Skin Flora Recovery 6-hours Post-treatment	6 hours post-treatment	Log10/cm2 recovery of skin flora at 6 hours following application of study treatment
Skin Flora Recovery 10 Minutes Post-treatment	10 minutes post-treatment	Log10/cm2 recovery of skin flora at 10 minutes following application of study treatments