Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2
Start Date
5/7/2021
Completion Date
3/31/2029
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.
Detailed Description
Specific Aim 1: To determine if the SEXTANT treatment strategy designed to address the modern wound bioburden at the time of delayed wound closure/coverage is superior to the standard-of-care (SOC) antibiotic protocol. Our primary comparison will be the proportion of fracture-related infections (FRI) under the SEXTANT arm versus the FRI proportion for those under standard of care in the first 180 days following final wound closure/coverage. One-year rates of FRI will also be assessed. Secondary Aims: To compare rates of antibiotic-related complications (including aseptic nonunion) and serious adverse events (SAEs), including emergence of antibiotic-resistant pathogens, of the two treatment groups in the first 180 days following final wound closure/coverage. One-year rates will also be assessed. To compare the terminal bioburden of the wounds at the time of delayed closure/coverage as sampled by standard tissue microbiology and assess the effectiveness of the antibiotic regimen. (Exploratory) To employ emerging NextGen Sequencing rapid PCR platforms for wound pathogen identification in a sub-cohort of patients.
Eligibility Criteria
Age Range: 18 years to 64 years
Interventions
Standard of care
Vancomycin and Tobramycin
Conditions
Locations
Stanford University
Redwood City, California 94063
United States
_University of California, San Francisco
San Francisco, California 94110
United States
University of California at San Francisco
San Francisco, California 94110
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United States
St Mary's University/Tenent Health
West Palm Beach, Florida 33407
United States
Emory University School of Medicine
Atlanta, Georgia 30303
United States
Indiana University School of Medicine - Methodist Hospital
Indianapolis, Indiana 46202
United States
Indiana University/Eskenazi Health
Indianapolis, Indiana 46202
United States
University of Kentucky
Lexington, Kentucky 40506
United States
LSU Health Sciences
New Orleans, Louisiana 70112
United States
University of Maryland , MD Department of Orthopaedics
Baltimore, Maryland 21201
United States
Walter Reed Military Medical Center
Bethesda, Maryland 20889
United States
Harvard/Mass General/Brigham Hospitals
Boston, Massachusetts 02115
United States
Hennepin County Medical Center / Minneapolis
Minneapolis, Minnesota 55415
United States
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Dartmouth Hitchcock
Lebanon, New Hampshire 03766
United States
Jamaica Hospital Medical Center
Jamaica, New York 11418
United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27514
United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina 28203
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina 27157
United States
METROHealth
Cleveland, Ohio 44109
United States
Ohio State University Wexner Medical Center
Columbus, Ohio 43201
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma 73104
United States
Temple University
Philadelphia, Pennsylvania 19140
United States
Brown University/Rhode Island Hospital
Providence, Rhode Island 02905
United States
Rhode Island Hospital/Brown University
Providence, Rhode Island 02905
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
University of Texas Health Science Center - Houston
Houston, Texas 77030
United States
University of Virginia
Charlottesville, Virginia 22903
United States
Inova Fairfax MEdical Campus
Falls Church, Virginia 22042
United States
Virginia Commonwealth University Medical Center
Richmond, Virginia 23298
United States