Intramedullary Calcium Sulfate Antibiotic Depot

Description

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

Study Overview

Study Details

Study overview

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.

Intramedullary Calcium Sulfate Antibiotic Depot for Prevention of Open Fracture Related Infection: A Randomized Clinical Trial

Intramedullary Calcium Sulfate Antibiotic Depot

Condition
Open tíbia Fracture
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai, Los Angeles, California, United States, 90048

Macon

Atrium Health Navicent The Medical Center, Macon, Georgia, United States, 31201

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40508

New Orleans

Louisiana State University Health Sciences Center, New Orleans, Louisiana, United States, 70112

Charlotte

Atrium Health Carolinas Medical Center, Charlotte, North Carolina, United States, 28204

Concord

Atrium Health Cabarrus, Concord, North Carolina, United States, 28025

Winston-Salem

Atrium Health Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States, 27157

Hershey

Pennsylvania State University, Hershey, Pennsylvania, United States, 17033

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Winchester

Valley Health, Winchester, Virginia, United States, 22601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Patients 18 years and older
  • * Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Rachel B Seymour, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

Jessica Rivera, MD, PRINCIPAL_INVESTIGATOR, Louisiana State University Health Science Center

Study Record Dates

2028-01