Intramedullary Calcium Sulfate Antibiotic Depot

PHASE3RecruitingINTERVENTIONAL
Enrollment

497

Participants

Timeline

Start Date

April 8, 2024

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2028

Conditions
Open tíbia FractureOsteomyelitis TibiaTibial Fractures
Interventions
DRUG

Vancomycin Hydrochloride

The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate.

DRUG

Gentamicin

The intramedullary calcium sulfate antibiotic depot will be mixed sterilely to include at minimum 20cc calcium sulfate powder mixed with 1g of vancomycin powder and 1.2g of tobramycin powder per 10cc of calcium sulfate.

OTHER

Standard Intramedullary Nail

Standard Intramedullary Nail

Trial Locations (10)

17033

NOT_YET_RECRUITING

Pennsylvania State University, Hershey

22601

NOT_YET_RECRUITING

Valley Health, Winchester

27157

RECRUITING

Atrium Health Wake Forest Baptist Medical Center, Winston-Salem

28025

RECRUITING

Atrium Health Cabarrus, Concord

28204

RECRUITING

Atrium Health Carolinas Medical Center, Charlotte

31201

RECRUITING

Atrium Health Navicent The Medical Center, Macon

37232

NOT_YET_RECRUITING

Vanderbilt University Medical Center, Nashville

40508

NOT_YET_RECRUITING

University of Kentucky, Lexington

70112

RECRUITING

Louisiana State University Health Sciences Center, New Orleans

90048

NOT_YET_RECRUITING

Cedars-Sinai, Los Angeles

All Listed Sponsors
lead

Wake Forest University Health Sciences

OTHER