Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT
Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT - A Multicenter Randomized Control Trial
Major Extremity Trauma Research Consortium
1,200 participants
May 7, 2021
INTERVENTIONAL
Conditions
Summary
The proposed study is a multi-center, prospective randomized controlled trial comparing current standard of care treatment to the SEXTANT treatment protocol in patients with Type III open fractures of the tibia and IIIB fractures of the ankle and hindfoot.
Eligibility
Inclusion Criteria14
- 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
- Ages 18 - 64 years inclusive
- Patients may have risk factors for infection including diabetes, immunosuppression from steroids or other medications, HIV, or other infections.
- Patients may have a traumatic brain injury.
- Patients may have other fractures including spine, upper extremity fractures, contralateral lower extremity injuries, ipsilateral pelvis, hip, femur or foot injuries.
- 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.
- Patients may have co-existing non-tibial or hindfoot infection, with or without antibiotic treatment.
- Patients may be definitively stabilized using any method (nail, plate, ex fix or cast).
- Patients may have a fasciotomy.
Exclusion Criteria8
- Patient in current therapy for a wound, implant or fracture site infection related to the study site.
- 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)
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Interventions
Participants in the control group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection.
The patients in the SEXTANT cohort will have 1000 mg of Vancomycin and 1200 mg of Tobramycin administered to the wound surface, fracture site and exposed hardware (if any) just prior to suture closure of the wound or flap. The SEXTANT cohort will then receive at least 72 hours of systemic antibiotic therapy targeted to the modern wound bioburden.
Locations(31)
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NCT04678154