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

Launched by MAJOR EXTREMITY TRAUMA RESEARCH CONSORTIUM · Dec 18, 2020

Keywords

ClinConnect Summary

The SEXTANT clinical trial is studying a new way to provide antibiotic care for patients with severe open fractures, specifically Gustilo type III tibia fractures and type IIIB ankle and hindfoot fractures. This trial is comparing the current standard treatment with a new protocol called SEXTANT to see which method is more effective in preventing infections after surgery. The trial is open to adults aged 18 to 64 who have experienced these types of injuries and may have other health issues that could increase their risk of infection, such as diabetes or immunosuppression.

If you or a family member are eligible and choose to participate, you will receive either the standard treatment or the new SEXTANT protocol, and your recovery will be closely monitored. It’s important to note that individuals with ongoing infections at the surgery site or those who might struggle to keep follow-up appointments cannot participate. This study aims to improve care and outcomes for patients with severe fractures, and your involvement could help advance medical knowledge in this area.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 1. Injury meeting at least one of the following criteria:
• • Gustilo type III tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon) requiring a second procedure for final debridement and definitive coverage / closure following the index stabilization
• • Gustilo type IIIB ankle fractures (OTA 44)
• • Gustilo type IIIB calcaneus fractures (OTA 82)
• • Gustilo type IIIB talus fractures (OTA 81)
• • Traumatic "zone-of-injury" trans-tibial amputations requiring DPC, and/or flap coverage
• • 2. Ages 18 - 64 years inclusive
• • 3. Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
• • 4. Patients may have a traumatic brain injury.
• • 5. Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
• • 6. Patients may be treated initially at an outside institution prior to transfer to the study institution, as long as the definitive wound closure or coverage was not performed prior to entrance into the study.
• • 7. Patients with bilateral injuries that meet inclusion criteria may be included, but only the limb rated as "more severe" by the treating surgeon will be enrolled in the study.
• • 8. Patients may have co-existing non-tibial or hindfoot infection, with or without antibiotic treatment.
• • 9. Patients may be definitively stabilized using any method (nail, plate, ex fix or cast).
• • 10. Patients may have a fasciotomy.
• Exclusion Criteria:
• • 1. Patient in current therapy for a wound, implant or fracture site infection related to the study site.
• 2. Patient likely to have difficulty maintaining follow-up, including:
• • Diagnosis of a severe psychiatric condition
• • Intellectually challenged without adequate family support
• • Resides outside of the hospital's catchment area
• • Planning to follow-up at another medical center
• • Being a prisoner
• • Not having a means of contact (address, cell phone, home phone, e-mail)