Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

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.

Conditions

Osteomyelitis Tibia, Tibial Fractures, Open Tibia Fracture

Study Overview

Study Details

Study overview

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.

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Condition
Osteomyelitis Tibia
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida Gainesville, Gainesville, Florida, United States, 32607

Temple Terrace

Florida Orthopaedic Institute, Temple Terrace, Florida, United States, 33637

Macon

Atrium Health Navicent, Macon, Georgia, United States, 31201

Lexington

University of Kentucky, Lexington, Kentucky, United States, 40536

New Orleans

Louisiana State University - University Medical Center New Orleans, New Orleans, Louisiana, United States, 70112

Chapel Hill

University of North Carolina Chapel Hill, Chapel Hill, North Carolina, United States, 27546

Charlotte

Atrium Health Carolinas Medical Center, Charlotte, North Carolina, United States, 28203

Concord

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

Winston-Salem

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

Hershey

Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States, 17033

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 or older
  • * Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
  • * Less than 18 years of age
  • * Allergy to vancomycin or gentamicin
  • * Unable to speak English or Spanish
  • * Pregnant and lactating women
  • * Prisoner
  • * Unable to follow up for 12 months

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

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

Study Record Dates

2027-12