Intramedullary Calcium Sulfate Antibiotic Depot

Part of paid clinical trials in Los Angeles, California.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT05766670
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Open tíbia Fracture
  • Osteomyelitis Tibia
  • Tibial Fractures

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vancomycin Hydrochloride — DRUG
    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.
  • Gentamicin — DRUG
    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.
  • Standard Intramedullary Nail — OTHER
    Standard Intramedullary Nail

Study Details

The goal of this randomized clinical trial is to study the best treatment for open lower leg fractures to prevent infection. The main questions it aims to answer is if treating tibia fracture patients with a calcium sulfate antibiotic depot is better at preventing infection that the standard of care.

Key Dates

Start date
Apr 8, 2024
Status verified
Oct 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
497 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Other: Intramedullary calcium sulfate antibiotic depot prior to Intramedullary nailing (IMN) placement (CS)
    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 of care intramedullary nail (SN)
    Standard of care intramedullary nail

Primary Outcome Measure

Number of participants who develop deep surgical site infection (SSI) [ Time Frame: Month 12 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
Cedars-SinaiLos AngelesCalifornia90048
Geoffrey Marecek, MD
Joel Arnold
[email protected]
Geoffrey Marecek, MD (PRINCIPAL_INVESTIGATOR)
Atrium Health Navicent The Medical CenterMaconGeorgia31201
Jarrod Dumpe, MD
[email protected]
Adithi Shyam
[email protected]
University of KentuckyLexingtonKentucky40508
Paul Matuszewski, MD
Matthew Eubank, BSN
[email protected]
Paul Matuszewski, MD (PRINCIPAL_INVESTIGATOR)
Louisiana State University Health Sciences CenterNew OrleansLouisiana70112
Jessica Rivera, MD
[email protected]
Carolyn Bridgman
[email protected]
Atrium Health Carolinas Medical CenterCharlotteNorth Carolina28204
Joseph Hsu, MD
[email protected]
Christine Churchill, MA
[email protected]
Atrium Health CabarrusConcordNorth Carolina28025
Luke Harmer, MD
[email protected]
Erica Grochowski, MPH
[email protected]
Atrium Health Wake Forest Baptist Medical CenterWinston-SalemNorth Carolina27157
Christine Churchill, MA
[email protected]
704-355-2000
Rachel B Seymour, PhD (PRINCIPAL_INVESTIGATOR)
Pennsylvania State UniversityHersheyPennsylvania17033
Jana Davis, MD
Andrea Myers
[email protected]
Jana Davis, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt University Medical CenterNashvilleTennessee37232
William Obremskey
Karen Trochez
[email protected]
William Obremskey, MD (PRINCIPAL_INVESTIGATOR)
Valley HealthWinchesterVirginia22601
Ken Nelson, MD
Ashley Zelaski
[email protected]
Ken Nelson, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cedars-Sinai· Los Angeles, CAAtrium Health Navicent The Medical Center· Macon, GAUniversity of Kentucky· Lexington, KYLouisiana State University Health Sciences Center· New Orleans, LAAtrium Health Carolinas Medical Center· Charlotte, NCAtrium Health Cabarrus· Concord, NC

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