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RECRUITING
NCT04678154
PHASE3

Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT 2

Sponsor: Major Extremity Trauma Research Consortium

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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