Evaluating Antibiotic Strategies for Severe Open Fractures (SEXTANT 2)
This study is testing two different ways to prevent infections after severe open fractures (when the bone breaks through the skin). You could receive either the standard care for preventing and treating infection, or a new approach called SEXTANT. The SEXTANT approach involves 72 hours of systemic antibiotics (given throughout the body) and applying Vancomycin and Tobramycin directly to the wound during surgery. Researchers want to see if the SEXTANT approach is better at preventing deep surgical site infections (infections that affect the bone or surrounding tissues) within 180 days after your wound is closed. This study is for adults aged 18 to 64 with specific types of severe open tibia, ankle, calcaneus, or talus fractures. The current status of this study is unclear, and it plans to enroll 600 participants.
- Study design
- This is an interventional study where participants will be randomly assigned to receive either standard care or the SEXTANT experimental protocol. It plans to enroll 600 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for deep surgical site infection for 180 days after final wound closure/coverage, with one-year rates also assessed.
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Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2
At a glance
Conditions
Where it's being run
31 sites across 21 statesStudy leadership
- Micahel J Bosse, MD · PRINCIPAL_INVESTIGATOR · Carolinas Medical Center
- Rachel Seymour, PhD · PRINCIPAL_INVESTIGATOR · Atrium Health Musculoskeletal Institute Research
- Renan C Castillo, PhD · PRINCIPAL_INVESTIGATOR · Johns Hopkins Bloomberg School of Public Health
- Anthony R Carlini, MS · PRINCIPAL_INVESTIGATOR · Johns Hopkins Bloomberg School of Public Health
Who to contact
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What this trial measures
- Deep surgical site infection180 days from final wound closure/cloverage
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.