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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03681990 | In Vivo Preoperative Skin Preparation Efficacy Study Within a Defined Product Coverage Area | PHASE2 | COMPLETED | 28 | — | — | Jun 6, 2017 | Jul 4, 2017 | Oct 2, 2024 | 1 | Romania |
The primary measure of efficacy is change in skin flora log10 CFU/cm\^2 in each of the skin sampling sites relative to baseline skin flora log10 CFU/cm\^2. Baseline samples must satisfy the greater than or equal to 3.0 in each of the sampling sites, to be used for data analysis.
| Arm | Type | Description |
|---|---|---|
| 3M CHG/IPA Prep / Center | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from center test site on skin in application area. |
| 3M CHG/IPA Prep / Mid-peripheral | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from mid-peripheral test site on skin in application area. |
| 3M CHG/IPA Prep / Peripheral | EXPERIMENTAL | Chlorhexidine gluconate (CHG) 2% / Isopropyl alcohol (IPA) 70% solution applied topically to intact skin; sample collected from peripheral test site on skin in application area. |
| Name | Type | Description |
|---|---|---|
| 3M CHG/IPA Prep | DRUG | Apply topically to intact skin |
Inclusion Criteria: * Male subjects of any race who are at least 18 years of age, * Subjects must have an area on their back region to accommodate the treatment coverage area, * Subjects must be in good general health, * Subjects who satisfy all inclusion/exclusion criteria and will voluntarily rea...