Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02203591 | In Vivo Efficacy Study of Patient Preoperative Preps | PHASE3 | COMPLETED | 738 | — | — | Jul 1, 2014 | Mar 1, 2015 | Nov 23, 2020 | 1 | United States |
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.
10 minute log reduction
| Arm | Type | Description |
|---|---|---|
| 3M CHG/IPA Prep C | EXPERIMENTAL | 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 | EXPERIMENTAL | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| ChloraPrep | ACTIVE_COMPARATOR | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| Normal Saline | PLACEBO_COMPARATOR | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| Name | Type | Description |
|---|---|---|
| 3M CHG/IPA Prep C | DRUG | 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 | DRUG | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| ChloraPrep | DRUG | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
| Normal Saline | DRUG | Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes. |
Inclusion Criteria: * Subjects of any race * Subjects in good 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 area * Topi...