Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05766670

Intramedullary Calcium Sulfate Antibiotic Depot

Led by Wake Forest University Health Sciences · Updated on 2025-12-15

497

Participants Needed

10

Research Sites

194 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Intramedullary Calcium Sulfate Antibiotic Depot

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years and older
  • Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Not Eligible

You will not qualify if you...

  • Less than 18 years of age
  • Allergy to vancomycin or tobramycin
  • Hypercalcemia
  • Unable to speak English or Spanish
  • No email, phone, or other point of contact
  • Pregnant and lactating women
  • Prisoner

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Cedars-Sinai

Los Angeles, California, United States, 90048

Actively Recruiting

2

Atrium Health Navicent The Medical Center

Macon, Georgia, United States, 31201

Actively Recruiting

3

University of Kentucky

Lexington, Kentucky, United States, 40508

Not Yet Recruiting

4

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States, 70112

Actively Recruiting

5

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States, 28204

Actively Recruiting

6

Atrium Health Cabarrus

Concord, North Carolina, United States, 28025

Actively Recruiting

7

Atrium Health Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

8

Pennsylvania State University

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

9

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Not Yet Recruiting

10

Valley Health

Winchester, Virginia, United States, 22601

Actively Recruiting

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Research Team

C

Christine Churchill, MA

CONTACT

R

Rachel B Seymour, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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