Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,550

Participants

Timeline

Start Date

May 11, 2021

Primary Completion Date

July 30, 2025

Study Completion Date

September 30, 2025

Conditions
Post Operative Surgical Site Infection
Interventions
DRUG

Treatment group

Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed, which is placed right before wound closure at the final stafe of definitive fracture fixation.

DRUG

Control group

Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed, which is placed right before wound closure at the final stage of definitive fracture fixation.

Trial Locations (41)

10021

New York Presbyterian/Hospital for Special Surgery, New York

11418

Jamaica Hospital Medical Center, Queens

17033

Penn State College of Medicine, Hershey

19106

University of Pennsylvania Perelman School of Medicine, Philadelphia

19140

Temple University, Philadelphia

21201

University of Maryland Shock Trauma Center, Baltimore

University of Maryland Shock Trauma/Capitol Regions, Baltimore

22042

Inova Fairfax MEdical Campus, Falls Church

22903

University of Virginia, Charlottesville

23298

Virginia Commonwealth University Medical Center, Richmond

27157

Atrium Health Wake Forest Baptist, Winston-Salem

27514

University of North Carolina at Chapel Hill, Chapel Hill

28203

Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute, Charlotte

29425

Medical University of South Carolina -, Charleston

33407

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

35205

University of Alabama Heersink School of Medicine, Birmingham

37232

Vanderbilt University, Nashville

39216

University of Mississippi Medical Center, Jackson

40506

University of Kentucky, Lexington

43201

Ohio State University Wexner Medical Center, Columbus

44109

METROHealth, Cleveland

46202

Indiana University School of Medicine - Methodist Hospital, Indianapolis

Indiana University/Eskenazi Health, Indianapolis

49503

Core Well Health, Grand Rapids

53705

University of Wisconsin, Madison

55415

Hennepin County Medical Center, Minneapolis

60153

Loyola University Chicago, Chicago

70112

LSU Health Sciences, New Orleans

73104

University of Oklahoma College of Medicine, Oklahoma City

75246

Baylor Scott & White Research Institute, Dallas

77030

UTHealth/McGovern Medical School, Houston

78229

UT Health San Antonio, San Antonio

80045

University of Colorado Anschutz Medical Campus, Aurora

84108

University of Utah, Salt Lake City

90033

Keck School of Medicine of USC, Los Angeles

90069

Cedars Sinai, West Hollywood

94063

Stanford University, Redwood City

94110

_University of California, San Francisco, San Francisco

02115

Harvard/Mass General/Brigham Hospitals, Boston

03766

Dartmouth Hitchcock, Lebanon

02905

Rhode Island Hospital/Brown University, Providence

All Listed Sponsors
collaborator

United States Department of Defense

FED

lead

Major Extremity Trauma Research Consortium

OTHER

NCT04597008 - Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA | Biotech Hunter | Biotech Hunter