Post Operative Surgical Site Infection
Conditions
Keywords
Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities
Brief 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").
Detailed description
Specific Aim 1: Compare the proportion of deep surgical site infections (SSI) of the study injury within 182 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 only gram-negative bacteria, infection by any gram-positive bacteria (with or without other organisms of any type), 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.
Interventions
DRUGTreatment group
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.
DRUGControl group
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.
Sponsors
Major Extremity Trauma Research Consortium
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 days later after swelling has resolved. 2. Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment. 3. Tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds. * Patients ages 18 through 80 years.
Exclusion criteria
* Study injury is already infected at time of study enrollment. * Definitive fixation of the study injury prior to enrollment in the study. * The patient never receives study fixation. * Massive myonecrosis from ipsilateral leg compartment syndrome. * Currently pregnant. * Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury, those who are intellectually challenged without adequate family support, or are unwilling to provide phone and address contact information). * Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome). * Patients with allergies, drug administration reactions, or other sensitivities to Tobramycin or other aminoglycosides.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Deep Surgical Site Infection (SSI) | within 182 days of definitive fracture fixation surgery | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert V O'Toole, MD, MS
University of Maryland, Department of Orthopaedic Trauma
PRINCIPAL_INVESTIGATORRenan C Castillo, PhD
Johns Hopkins Bloomberg School of Public Health
STUDY_DIRECTORAnthony R Carlini, MS
Johns Hopkins Bloomberg School of Public Health
Participant flow
Recruitment details
The study was conducted at 39 trauma centers in the US between June 18, 2021, and January 31, 2025. Patients meeting inclusion and exclusion crtieria were screened and approached by the research team at each trauma center. All patients or their legally authorized representatives provided signed informed consent.
Pre-assignment details
A total of 2310 patients were screened and a total of 1528 were adjudicated as eligible and included in the primary analysis.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 47.3 Years STANDARD_DEVIATION 13.8 |
| Fracture location Tibial pilon | 671 Participants |
| Fracture location Tibial plateau | 437 Participants |
| Open/closed Fracture Closed Fractures | 606 Participants |
| Open/closed Fracture Open Fractures | 302 Participants |
| Race/Ethnicity, Customized African American | 131 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 13 Participants |
| Race/Ethnicity, Customized Asian | 7 Participants |
| Race/Ethnicity, Customized Hispanic | 217 Participants |
| Race/Ethnicity, Customized More than one race | 80 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic | 1297 Participants |
| Race/Ethnicity, Customized Refused to report | 14 Participants |
| Race/Ethnicity, Customized Refused to report race | 15 Participants |
| Race/Ethnicity, Customized White | 1017 Participants |
| Sex: Female, Male Female | 307 Participants |
| Sex: Female, Male Male | 468 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 8 / 775 | 3 / 753 |
| other Total, other adverse events | 42 / 775 | 35 / 753 |
| serious Total, serious adverse events | 1 / 775 | 1 / 753 |
Outcome results
None listed