Post Operative Surgical Site Infection Clinical Trial
Official title:
Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA - A Multicenter Randomized Controlled Trial
The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").
Specific Aim 1: Compare the proportion of deep surgical site infections (SSI) of the study injury within 365 days of definitive fracture fixation surgery in patients allocated to receive a combination of local Vancomycin and Tobramycin powders compared to patients allocated to local Vancomycin powder. Sensitivity Analyses: A series of sensitivity analyses will be conducted to look at alternative measures of deep SSI under Specific Aim 1. These sensitivity analyses will consider the following alternative end points of deep SSI: infection by gram-negative bacteria, infection by gram-positive bacteria, polymicrobial pathogenic infections, culture negative infections, and cellulitis/skin infections. Specific Aim 2: To compare the safety of treatment with a combination of local Vancomycin and Tobramycin versus Vancomycin powder alone as measured by the proportion of antibiotic resistance in each arm. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02227446 -
Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (VANCO)
|
Phase 3 | |
| Recruiting |
NCT04678154 -
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
|
Phase 3 | |
| Completed |
NCT01798810 -
Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery
|
N/A |