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Intramedullary Calcium Sulfate Antibiotic Depot

NCT05766670 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 497

Last updated 2025-12-15

No results posted yet for this study

Summary

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.

Conditions

  • Open tíbia Fracture
  • Osteomyelitis Tibia
  • Tibial 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

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Rachel B Seymour, PhD · Wake Forest University Health Sciences

  • Jessica Rivera, MD · Louisiana State University Health Science Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-08
Primary Completion
2027-01-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05766670 on ClinicalTrials.gov