Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT - A Multicenter Randomized Control Trial
Major Extremity Trauma Research Consortium
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.
Description
Specific Aim 1: To compare the surgical site infection (SSI) rates of the current severe open fracture antibiotic strategy to a revised SEXTANT treatment strategy designed to address the modern wound bioburden at the time of wound closure or coverage. Specific Aim 2: To compare the terminal bioburden of the wounds at the time of definitive closure or coverage as sampled by standard tissue microbiology. Specific Aim 3: To compare rates of antibiotic-related serious adverse events (SAEs) of the two treatment groups. Exploratory Aim 4: To pilot the use of available and emerging rapid PCR platf…
Eligibility
- Age range
- 18–64 years
- Sex
- All
- Healthy volunteers
- No
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 incl…
Interventions
- DrugStandard of care
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.
- DrugVancomycin and Tobramycin
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)
- Stanford UniversityRedwood City, California
- _University of California, San FranciscoSan Francisco, California
- University of California at San FranciscoSan Francisco, California
- University of Colorado Anschutz Medical CampusAurora, Colorado
- St Mary's University/Tenent HealthWest Palm Beach, Florida
- Emory University School of MedicineAtlanta, Georgia