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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03224299 | Effectiveness of an Antimicrobial Agent for Preoperative Skin Preparation | PHASE2 | COMPLETED | 131 | — | — | Jun 21, 2017 | Oct 3, 2017 | Apr 23, 2021 | 2 | United States |
| Arm | Type | Description |
|---|---|---|
| Investigational Product #1 (IP1) | EXPERIMENTAL | octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear |
| Investigational Product #2 (IP2) | EXPERIMENTAL | octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted |
| Active Control | ACTIVE_COMPARATOR | ChloraPrep® - Hi-Lite Orange® applicator |
| Negative Control | PLACEBO_COMPARATOR | sterile 0.9% saline applied with single use applicator |
| Name | Type | Description |
|---|---|---|
| OCT - clear | DRUG | Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear |
| OCT- tinted | DRUG | Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted |
| ChloraPrep | OTHER | Active Control: ChloraPrep® - Hi-Lite Orange® applicator |
| Saline | OTHER | Negative Control: sterile 0.9% saline applied with single use applicator |
Inclusion Criteria: * Subjects may be of either sex, at least 18 years of age and of any race. * Subjects must be in good general health. * Subjects must read and sign an Informed Consent Form, Authorization to Use and Disclose Protected Health Information Form, and the List of Restricted Products ...