In-vivo Efficacy Study of Patient Preoperative Preps

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.

• 3M CHG/IPA Prep Colorless (Drug), also known as Chlorhexidine glucontate and Isopropyl alcohol, CHG 2% / IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%: Apply topically.
• 3M CHG/IPA Prep Tint (Drug), also known as Chlorhexidine glucontate and Isopropyl alcohol, CHG 2%/IPA 70%, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%: Apply topically.
• ChloraPrep (Drug), also known as ChloraPrep One-Step, ChloraPrep Patient Preoperative Skin Preparation, 2% CHG/70% IPA, Chlorhexidine glucontate and Isopropyl alcohol, Chlorhexidine gluconate 2% / Isopropyl alcohol 70%: Apply topically.
• Saline (Drug), also known as 0.9% NaCl, Normal Saline: Apply topically.

Primary outcomes

• 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 outcomes

• Safety as Assessed by Skin Irritation Scores [Baseline]: 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.
• Safety as Assessed by Skin Irritation Scores [10 minutes 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.
• 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.

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

Participant flow

Outcome results

• Responder Rate (Primary)
• Skin Flora Baseline for Abdominal and Inguinal Regions (Primary)
• Skin Flora Recovery Post-treatment (Primary)
• Reduction of Skin Flora Post-treatment (Primary)
• Safety as Assessed by Skin Irritation Scores (Secondary), Count of participants, Participants: 3M CHG/IPA Prep Colorless Abdominal Region 101; 3M CHG/IPA Prep Tint Abdominal Region 93; ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region 96; Normal Saline Abdominal Region 32; 3M CHG/IPA Prep Colorless Inguinal Region 97; 3M CHG/IPA Prep Tint Inguinal Region 97; ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region 96; Normal Saline Inguinal Region 30
• Safety as Assessed by Skin Irritation Scores (Secondary), Count of participants, Participants: 3M CHG/IPA Prep Colorless Abdominal Region 101; 3M CHG/IPA Prep Tint Abdominal Region 93; ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region 96; Normal Saline Abdominal Region 32; 3M CHG/IPA Prep Colorless Inguinal Region 97; 3M CHG/IPA Prep Tint Inguinal Region 97; ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region 96; Normal Saline Inguinal Region 30
• Safety as Assessed by Skin Irritation Scores (Secondary), Count of participants, Participants: 3M CHG/IPA Prep Colorless Abdominal Region 101; 3M CHG/IPA Prep Tint Abdominal Region 93; ChloraPrep CHG/IPA Hi-Lite Orange Tint Abdominal Region 96; Normal Saline Abdominal Region 32; 3M CHG/IPA Prep Colorless Inguinal Region 97; 3M CHG/IPA Prep Tint Inguinal Region 99; ChloraPrep CHG/IPA Hi-Lite Orange Tint Inguinal Region 97; Normal Saline Inguinal Region 31

Adverse events

Time frame: Adverse events (AEs) were collected on treatment day (1 day), thus all AEs by definition would be treatment-emergent.

• Robert R McCormack, BS, Principal investigator, BioScience Laboratories, Inc.