Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Standard of Care · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| SOC + Amicidin-β topical solution - 15 mL | EXPERIMENTAL | In addition to Standard of Care (SOC), patients will receive Amicidin-β topical solution - 15 mL immediately prior to wound closure/dressing, with rinsing out with saline. |
| SOC + Amicidin-β topical solution - 50 mL - Scheme 1 | EXPERIMENTAL | In addition to Standard of Care (SOC), patients will be receive Amicidin-β topical solution - 50 mL immediately prior to wound closure/dressing, with rinsing out with saline |
| SOC + Amicidin-β topical solution - 50 mL - Scheme 2 | EXPERIMENTAL | In addition to Standard of Care (SOC), patients will be receive Amicidin-β topical solution - 50 mL immediately prior to wound closure/dressing, without rinsing out with saline |
| SOC | ACTIVE_COMPARATOR | Patients will receive Standard of Care (SOC) only |
| Name | Type | Description |
|---|---|---|
| Amicidin-β topical solution - 15 mL | DRUG | Amicidin-β topical solution for local administration - 15 mL |
| Amicidin-β topical solution - 50 mL | DRUG | Amicidin-β topical solution for local administration - 50 mL |
| Standard of Care (SOC) | DRUG | Per institutional Standard Of Care |
Main Inclusion Criteria: * Body Mass Index between 18.5 kg/square meter and 39.9kg/square meter * Surgical or traumatic wound determined by the Investigator to be infected within 90 days of surgery or trauma, with longest dimension between 3 and 15 cm. The diagnosis should include one or more of th...