RECRUITING

Intramedullary Calcium Sulfate Antibiotic Depot

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Conditions

Open tíbia FractureOsteomyelitis TibiaTibial Fracturesantibiotic depot

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-04-08
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05766670

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients 18 years and older
  2. * Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
  1. * Less than 18 years of age
  2. * Allergy to vancomycin or tobramycin
  3. * Hypercalcemia
  4. * Unable to speak English or Spanish
  5. * No email, phone, or other point of contact
  6. * Pregnant and lactating women
  7. * Prisoner

Contacts and Locations

Study Contact

Christine Churchill, MA
CONTACT
7043552000
christine.churchill@atriumhealth.org
Rachel B Seymour, PhD
CONTACT
7043552000
rachel.seymour@atriumhealth.org

Principal Investigator

Rachel B Seymour, PhD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Jessica Rivera, MD
PRINCIPAL_INVESTIGATOR
Louisiana State University Health Science Center

Study Locations (Sites)

Cedars-Sinai
Los Angeles, California, 90048
United States
Atrium Health Navicent The Medical Center
Macon, Georgia, 31201
United States
University of Kentucky
Lexington, Kentucky, 40508
United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112
United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28204
United States
Atrium Health Cabarrus
Concord, North Carolina, 28025
United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
United States
Pennsylvania State University
Hershey, Pennsylvania, 17033
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Valley Health
Winchester, Virginia, 22601
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-08
Study Completion Date2028-01

Study Record Updates

Study Start Date2024-04-08
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • antibiotic depot

Additional Relevant MeSH Terms

  • Open tíbia Fracture
  • Osteomyelitis Tibia
  • Tibial Fractures