RECRUITING

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

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Conditions

Osteomyelitis TibiaTibial FracturesOpen Tibia FractureAntibiotic-coated nail

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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

This prospective randomized clinical trial will compare outcomes between patients treated primarily with a prophylactic antibiotic coated nail and those treated with traditional standard of care intramedullary (IM) nailing.

Official Title

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Quick Facts

Study Start:2023-05-15
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05421741

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 or older
  2. * Gustilo 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 gentamicin
  3. * Unable to speak English or Spanish
  4. * Pregnant and lactating women
  5. * Prisoner
  6. * Unable to follow up for 12 months

Contacts and Locations

Study Contact

Rachel Seymour, PhD
CONTACT
7043552000
Rachel.Seymour@atriumhealth.org
Christine Churchill, MA
CONTACT
7043552000
Christine.Churchill@atriumhealth.org

Principal Investigator

Joseph Hsu, MD
PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences

Study Locations (Sites)

University of Florida Gainesville
Gainesville, Florida, 32607
United States
Florida Orthopaedic Institute
Temple Terrace, Florida, 33637
United States
Atrium Health Navicent
Macon, Georgia, 31201
United States
University of Kentucky
Lexington, Kentucky, 40536
United States
Louisiana State University - University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27546
United States
Atrium Health Carolinas Medical Center
Charlotte, North Carolina, 28203
United States
Atrium Health Cabarrus
Concord, North Carolina, 28025
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
The University of Texas Medical Branch
Galveston, Texas, 77555
United States
University of Texas Houston
Houston, Texas, 77030
United States
San Antonio Military Medical Center
San Antonio, Texas, 78234
United States
Inova
Fairfax, Virginia, 22031
United States
Valley Health System
Winchester, Virginia, 22601
United States

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Joseph Hsu, MD, PRINCIPAL_INVESTIGATOR, Wake Forest University Health Sciences

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 Date2023-05-15
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-05-15
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • Antibiotic-coated nail

Additional Relevant MeSH Terms

  • Osteomyelitis Tibia
  • Tibial Fractures
  • Open Tibia Fracture