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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01888367 | Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery | PHASE2 | COMPLETED | 445 | — | — | Oct 1, 2013 | Feb 1, 2015 | Oct 11, 2016 | 31 | United States |
| Arm | Type | Description |
|---|---|---|
| DFA-02 Antibiotic Gel | EXPERIMENTAL | Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. |
| DFA-02 Placebo Gel | PLACEBO_COMPARATOR | Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. |
| Standard of Care | NO_INTERVENTION | Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied. |
| Name | Type | Description |
|---|---|---|
| DFA-02 Antibiotic Gel | DRUG | - |
| DFA-02 Placebo Gel | DRUG | - |
Inclusion Criteria: 1. Males and females 18 years of age or older; 2. If female, the subject must be postmenopausal, surgically sterilized or, if of child-bearing potential, she must have a negative serum or urine pregnancy test within 48 hours of surgery and agree to use adequate birth control dur...