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Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2
Sponsor: Major Extremity Trauma Research Consortium
Summary
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 final wound closure/coverage combined with 72 hours of systemic antibiotic coverage targeted to both gram-positive and gram-negative pathogens. The study will compare the results of the current SOC prophylactic coverage to the strategic wound bioburden treatment (SEXTANT) protocol. Up until the time of definitive wound closure/coverage, all patients will be treated per the usual regimen of the surgeon / center and in accordance with current Trauma Quality Improvement Program (TQIP) and Surgical Quality Improvement Program (SQIP) recommendations for the care of open fractures.14,15,17 It includes the administration of systemic antibiotics as close to the time of injury as possible. In the definitive wound closure/coverage procedure post-operative period, participants in the intervention arm will receive 72 hours of systemic antibiotic therapy targeted at the modern wound bioburden, and patients in the usual care arm will receive post-operative care per the usual practice of their surgeon. All other activities related to follow-up and related treatments will proceed per the usual practice of the surgeon.
Official title: Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2 - A Continuation of the Multicenter Randomized Control Trial SEXTANT 1
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2021-05-07
Completion Date
2029-03-31
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
Standard of care
Participants in the control group will receive standard care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Topical antibiotics are allowed, if SOC for the institution, but are not mandated.
Vancomycin and Tobramycin
The patients in the SEXTANT cohort will receive 72 hours of targeted systemic antibiotic therapy (Table 2) and 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. 72-hour of systemic gram-positive and gram-negative antibiotic coverage to target the terminal wound bioburden. The antibiotics coverage proposed as the primary choice includes PO Ciprofloxacin + PO linezolid or IV Ciprofloxacin and IV Vancomycin. The preferred antibiotic regimen will be decided by study's ID team, in cooperation with the ID and Antibiotic Stewardship teams at each site. Antibiotic recommendations will be adjusted, if needed, to account for a Site's bacteria susceptibility / resistance profile, or the specific needs of an individual patient.
Locations (31)
Stanford University
Redwood City, California, United States
_University of California, San Francisco
San Francisco, California, United States
University of California at San Francisco
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
St Mary's University/Tenent Health
West Palm Beach, Florida, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana, United States
Indiana University/Eskenazi Health
Indianapolis, Indiana, United States
University of Kentucky
Lexington, Kentucky, United States
LSU Health Sciences
New Orleans, Louisiana, United States
University of Maryland , MD Department of Orthopaedics
Baltimore, Maryland, United States
Walter Reed Military Medical Center
Bethesda, Maryland, United States
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts, United States
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States
METROHealth
Cleveland, Ohio, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Temple University
Philadelphia, Pennsylvania, United States
Brown University/Rhode Island Hospital
Providence, Rhode Island, United States
Rhode Island Hospital/Brown University
Providence, Rhode Island, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center - Houston
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Inova Fairfax MEdical Campus
Falls Church, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States