Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Control group · 1 trial · 1 indication
Compare the proportion of deep SSIs of the study injury within 182 days of definitive fracture fixation surgery in patients treated with local Vancomycin powder compared to those treated with a combination of local Vancomycin and Tobramycin powders. For this study a "deep SSI" is a SSI that is treated with operative debridement. In the current CDC terminology this would include all deep organ space, deep incisional, and superficial infections that are treated with surgery.
| Arm | Type | Description |
|---|---|---|
| Control | ACTIVE_COMPARATOR | Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed, which is placed right before wound closure at the final stage of definitive fracture fixation. |
| Treatment | EXPERIMENTAL | Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed, which is placed right before wound closure at the final stafe of definitive fracture fixation. |
| Name | Type | Description |
|---|---|---|
| Treatment group | DRUG | Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed, which is placed right before wound closure at the final stafe of definitive fracture fixation. |
| Control group | DRUG | Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed, which is placed right before wound closure at the final stage of definitive fracture fixation. |
Inclusion Criteria: * Tibial plateau or tibial pilon fractures that is treated operatively with plate and screw fixation AND at least one of the following characteristics indicative of higher risk of infection: 1. Initially treated with an external fixation and treated definitively more than 3 d...
Control group is a Phase 3 investigational small molecule being studied for the prevention of post operative surgical site infection. It is being evaluated in a completed clinical trial involving 1,660 patients who underwent operative treatment of fractures at high risk of infection. The drug is developed by United Therapeutics Corporation.
Control group is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol UTHR. The company is conducting clinical research on this investigational small molecule for the prevention of post operative surgical site infection.
Control group is in Phase 3 clinical development. It has completed one Phase 3 trial with 1,660 enrolled participants. The drug is still investigational and has not been approved by regulatory authorities for the prevention of post operative surgical site infection.
Control group has been studied in one completed Phase 3 clinical trial registered as NCT04597008. The trial, titled "Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA," enrolled 1,660 adult patients in the United States.
Control group is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the prevention of post operative surgical site infection. The completed clinical trial NCT04597008 has finished, but regulatory approval has not been granted.