In-vivo Efficacy Study of Patient Preoperative Preps

Phase 3

Terminated

Interventions: Drug: 3M CHG/IPA Prep Colorless
Drug: 3M CHG/IPA Prep Tint
Drug: ChloraPrep
Drug: Saline

Brief Summary: 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.

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
3M CHG/IPA Prep Colorless	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.
3M CHG/IPA Prep Tint	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.
ChloraPrep Hi-Lite Orange	ChloraPrep	Applied topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
Normal Saline	Saline	Applied 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 minute 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 at 6 hours. 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 at 6 hours.
Skin Flora Baseline for Abdominal and Inguinal Regions	Baseline	Log10/cm2 baseline skin flora for abdominal and inguinal regions
Skin Flora Recovery Post-treatment	10 minutes and 6 hours post-treatment	Log10/cm2 recovery of skin flora at 10 minutes and 6 hours following application of study treatments for abdominal and inguinal regions
Reduction of Skin Flora Post-treatment	Baseline, 10 minutes and 6 hours	Log10/cm2 reduction of skin flora, relative to Treatment Day baseline log10/cm2, at 10 minutes and 6 hours

Secondary Outcome Measures

Name	Time	Method
Safety as Assessed by Skin Irritation Scores	6 hours post-treatment	Skin irritation rating (0-3) scores for dryness, edema, erythema and rash. 0 = no reaction, 1 = mild, 2 = moderate, 3 = severe. A skin irritation rating of 3 in any category represents significant irritation and qualifies as an adverse event.