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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,200

Participants

Timeline

Start Date

May 7, 2021

Primary Completion Date

September 30, 2026

Study Completion Date

March 31, 2027

Conditions
Post Operative Surgical Site Infection
Interventions
DRUG

Standard 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.

DRUG

Vancomycin 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.

Trial Locations (31)

11418

RECRUITING

Jamaica Hospital Medical Center, Jamaica

19140

RECRUITING

Temple University, Philadelphia

20889

RECRUITING

Walter Reed Military Medical Center, Bethesda

21201

RECRUITING

University of Maryland , MD Department of Orthopaedics, Baltimore

22042

RECRUITING

Inova Fairfax MEdical Campus, Falls Church

22903

RECRUITING

University of Virginia, Charlottesville

23298

RECRUITING

Virginia Commonwealth University Medical Center, Richmond

27157

RECRUITING

Atrium Health Wake Forest Baptist, Winston-Salem

27514

RECRUITING

University of North Carolina at Chapel Hill, Chapel Hill

28203

RECRUITING

Atrium Health Carolinas Medical Center, Charlotte

30303

RECRUITING

Emory University School of Medicine, Atlanta

33407

RECRUITING

St Mary's University/Tenent Health, West Palm Beach

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

39216

RECRUITING

University of Mississippi Medical Center, Jackson

40506

RECRUITING

University of Kentucky, Lexington

43201

RECRUITING

Ohio State University Wexner Medical Center, Columbus

44109

RECRUITING

METROHealth, Cleveland

46202

RECRUITING

Indiana University School of Medicine - Methodist Hospital, Indianapolis

RECRUITING

Indiana University/Eskenazi Health, Indianapolis

55415

RECRUITING

Hennepin County Medical Center / Minneapolis, Minneapolis

70112

RECRUITING

LSU Health Sciences, New Orleans

73104

RECRUITING

University of Oklahoma College of Medicine, Oklahoma City

77030

RECRUITING

University of Texas Health Science Center - Houston, Houston

80045

RECRUITING

University of Colorado Anschutz Medical Campus, Aurora

94063

RECRUITING

Stanford University, Redwood City

94110

RECRUITING

_University of California, San Francisco, San Francisco

RECRUITING

University of California at San Francisco, San Francisco

02115

RECRUITING

Harvard/Mass General/Brigham Hospitals, Boston

03766

RECRUITING

Dartmouth Hitchcock, Lebanon

02905

RECRUITING

Brown University/Rhode Island Hospital, Providence

RECRUITING

Rhode Island Hospital/Brown University, Providence

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Major Extremity Trauma Research Consortium

OTHER

NCT04678154 - Evaluation of a New Strategy for Protocolized Antibiotic Care for Severe Open Fractures: SEXTANT | Biotech Hunter | Biotech Hunter