The Vancomycin Study is a multi-center, prospective randomized controlled trial that will compare the proportion of deep surgical site infections within 6 months in patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder at the time of fracture fixation.
Primary Aim: Compare the proportion of deep surgical site infections within 6 months in patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder. Primary Hypothesis: The proportion of deep surgical site infections will be lower for patients treated with local Vancomycin powder. Secondary Aim #1: Compare antibiotic sensitivities of the bacteria in the patients who develop deep surgical site infections in study patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder. Hypothesis 1: In the patients who develop infections, the antibiotic sensitivity profiles between patients treated with local Vancomycin powder will be non-inferior to those treated without local Vancomycin powder. Secondary Aim #2: Build and validate a risk prediction model for the development of deep surgical site infections in patients treated without local Vancomycin powder. (b) Explore whether the effect of local Vancomycin powder is modified by the predicted risk of infection. Hypothesis 2: Patient (e.g. medical co-morbidities) and injury (e.g open fractures) factors will be highly predictive of infection risk. Hypothesis 3: Patients with higher predictive risk will experience greater benefit from local antibiotics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,036
At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure.
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Number of Clinically Significant Deep Surgical Site Infection (SSI)
The main outcome will be the presence of clinically significant surgical site infection (SSI) in the first 26 weeks after surgery, as determined by CDC guidelines. The CDC criteria is currently 3 months for surgical site infection. To help capture more infections the study investigators have moved the time frame back to 6 months. Wound characteristics will also be evaluated using the ASEPSIS score. In this system wounds are scored using the weighted sum of points assigned for predetermined criteria including the need for Additional treatment, presence of Serous drainage, Erythema, Purulent exudates, Separation of deep tissues, the Isolation of bacteria, and the duration of patients Stay (ASEPSIS). The study investigators will define deep infections as those that require operative treatment, and superficial infections as those that are treated without operative intervention.
Time frame: 26 weeks
Pathogen Type
This secondary outcome represents the type of bacteria or fungus isolated from the fracture site at the time of surgery for infection during the follow up period. Cultures were obtained using routine clinical sterile technique in the operating room and processed according to standard laboratory practices at each participating site. An infectious disease physician blinded to treatment arm reviewed and categorized all culture results. Pathogens were classified into five groups: gram-positive cocci, gram-positive rods, gram-negative rods, anaerobes, and fungi. The frequency of each pathogen type recovered was compared between patients who received topical vancomycin powder during surgery and those who did not.
Time frame: 26 weeks
Bacterial Susceptibility and Antimicrobial Resistance
This secondary outcome characterizes the susceptibility of recovered pathogens to commonly used antibiotics collected at the time of surgery for infection during follow up. Antimicrobial susceptibility testing was performed by hospital laboratories using standard methods at each participating site. The pattern of susceptibility and resistance to various antimicrobial agents was compared between the two treatment groups to assess whether exposure to topical vancomycin powder was associated with differences in antibiotic resistance profiles, including the emergence of resistant organisms or other hard-to-treat pathogens.
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Time frame: 26 weeks