Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2

Specific Aim 1: To determine if the SEXTANT treatment strategy designed to address the modern wound bioburden at the time of delayed wound closure/coverage is superior to the standard-of-care (SOC) antibiotic protocol. Our primary comparison will be the proportion of fracture-related infections (FRI) under the SEXTANT arm versus the FRI proportion for those under standard of care in the first 180 days following final wound closure/coverage. One-year rates of FRI will also be assessed. Secondary Aims: To compare rates of antibiotic-related complications (including aseptic nonunion) and serious adverse events (SAEs), including emergence of antibiotic-resistant pathogens, of the two treatment groups in the first 180 days following final wound closure/coverage. One-year rates will also be assessed. To compare the terminal bioburden of the wounds at the time of delayed closure/coverage as sampled by standard tissue microbiology and assess the effectiveness of the antibiotic regimen. (Exploratory) To employ emerging NextGen Sequencing rapid PCR platforms for wound pathogen identification in a sub-cohort of patients.