Trial Outcomes & Findings for Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (VANCO) (NCT NCT02227446)

Approximately 1000 participants (500 per treatment arm) were enrolled across 36 METRC trauma centers over a 30-month period. Participants were recruited during the initial hospitalization for the their injury.

Numbers differ because each arm had a different number of participants.

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.

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.

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.