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โ† Trials
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Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2

RecruitingPhase 3Ages 18 Years - 64 YearsAllMajor Extremity Trauma Research Consortium
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In plain words

What the trial is, and whether it could suit you

The PRCT evaluates infection outcomes as well as fracture and antibiotic-related complications to include the emergence of resistant bacteria associated with two different antibiotic strategies in the treatment of Gustilo type IIIB tibia and hindfoot fractures (calcaneus and talus) and selected IIIA fractures of the tibia and trauma-related transtibial amputations that are performed in the "zone-of-injury". This study will be conducted in established METRC level 1 trauma centers. The patients will be randomized as close to admission as possible to either 1) Standard of Care (SOC) prophylactic open fracture protocol, including the use of topical antibiotic as per the usual practice of the surgeon or 2) experimental protocol (SEXTANT). The SEXTANT protocol includes application of wound bioburden-targeted topical Vancomycin powder and Tobramycin powder antibiotic treatment at the time of f

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Injury meeting at least one of the following criteria: a. Gustilo type III fractures of the tibia (OTA 41 plateau, OTA 42 shaft and OTA 43 pilon); ankle (OTA 44); calcaneus (OTA 82) and/or talus (OTA 81) with injury characteristics meeting at least one of the following criteria: i. All IIIB fractures ii. IIIA fractures that require a planned second debridement prior to definitive closure / coverage iii. IIIA fractures with extensive contamination or muscle damage precluding definitive internal fixation at the time of initial surgery iv. IIIA fractures with extensive degloving or wound greater than 10 cm after debridement (if indicated, primary wound closure is allowed. Primary wound closure refers to the definitive closure of the wound at the initial surgical event, without plans for re-entry for additional debridement and/or fracture fixation) v. IIIA fractures severe fracture comminution resulting from high energy trauma (if indicated, primary wound closure/coverage is allowed) vi. IIIA fractures with AO/OTA OFC contamination level of severe with material imbedded into bone or soft tissue or with a severe high risk environmental contamination from farm, fecal, dirty water inoculation or other equivalent (if indicated, primary wound closure/coverage is allowed) vii. IIIA Fractures where the skin could be closed after extensive muscle or bone removal (if indicated, primary wound closure/coverage is allowed) viii. IIIA fractures with bone loss resulting in a circumferential gap of 1 cm after debridement (if indicated, primary wound closure/coverage is allowed) ix. Fractures where fasciotomies were performed for impending or diagnosed compartment syndromes (regardless of the initial open or closed classification of the fracture x. 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 transferring to the study institution, as long as the definitive wound closure/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 infections, with or without antibiotic treatment. 9. Patients may be definitively stabilized using any method (nail, plate, ex fix, or cast). 10. Patients may have fasciotomy. Exclusion Criteria: 1. Patient speaks neither English or Spanish 2. Patient in current therapy for a wound, implant or fracture site infection related to the study site. 3. Patient is pregnant, potentially pregnant, or lactating. 4. Patient likely to have difficulty maintaining follow-up, including: 1. Diagnosis of a severe psychiatric condition 2. Intellectually challenged without adequate family support 3. Resides outside of the hospital's catchment area, unless willing to follow-up by phone or telemedicine 4. Planning to follow-up at another medical center, unless willing to follow-up by phone or telemedicine 5. Being a prisoner 6. Not having a means of contact (address, cell phone, home phone, e-mail)
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What it tests

  • Standard of care
  • Vancomycin and Tobramycin
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Where

31 sites
Stanford University
Redwood City, United States
_University of California, San Francisco
San Francisco, United States
University of California at San Francisco
San Francisco, United States
University of Colorado Anschutz Medical Campus
Aurora, United States
St Mary's University/Tenent Health
West Palm Beach, United States
Emory University School of Medicine
Atlanta, United States
Indiana University School of Medicine - Methodist Hospital
Indianapolis, United States
Indiana University/Eskenazi Health
Indianapolis, United States

โ€ฆand 23 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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