Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA
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- STATUS
- Recruiting
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- End date
- May 31, 2024
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- participants needed
- 1900
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- sponsor
- Major Extremity Trauma Research Consortium
Summary
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").
Description
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.
Details
| Condition | Post Operative Surgical Site Infection |
|---|---|
| Treatment | Control group, Treatment group |
| Clinical Study Identifier | NCT04597008 |
| Sponsor | Major Extremity Trauma Research Consortium |
| Last Modified on | 4 October 2022 |
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