In Vivo Efficacy Study of Patient Preoperative Preps

Phase 3

Completed

Interventions: Drug: Normal Saline
Drug: 3M CHG/IPA Prep CH
Drug: ChloraPrep
Drug: 3M CHG/IPA Prep C

Brief Summary: The objective of this study is to demonstrate 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 site, a responder is defined as a subject with a 2-log10/cm2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at 6 hours.

On the inguinal site, a responder is defined as a subject with a 3-log10/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 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

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 CH	3M CHG/IPA Prep CH	Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
ChloraPrep	ChloraPrep	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 C	3M CHG/IPA Prep C	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 hours post-product application	On the abdominal region a responder is a subject with a 2 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time. On the inguinal region a responder is a subject with a 3 log10/cm\^2 bacterial reduction at 10 minutes and for whom the skin flora does not return to baseline at the 6-hour sample collection time.
Alternative Primary	Baseline and 10 minutes	10 minute log reduction

Secondary Outcome Measures

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