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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01968707 | In-vivo Efficacy Study of Patient Pre-operative Preps | PHASE3 | COMPLETED | 426 | — | — | Oct 1, 2013 | Jun 1, 2014 | Oct 2, 2024 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| ChloraPrep Hi-Lite Orange | 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. |
| 3M CHG/IPA Prep Tint 10.5 mL | 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 Tint 26-mL | EXPERIMENTAL | 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 |
|---|---|---|
| ChloraPrep Hi-Lite Orange | DRUG | Apply topically. |
| Normal saline | DRUG | Apply topically. |
| 3M CHG/IPA Prep Tint 10.5-mL | DRUG | Apply topically. |
| 3M CHG/IPA Prep Tint 26-mL | DRUG | Apply topically |
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 are...