Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05421741

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Led by Wake Forest University Health Sciences · Updated on 2026-03-18

484

Participants Needed

14

Research Sites

237 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older
  • Gustilo 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 gentamicin
  • Unable to speak English or Spanish
  • Pregnant and lactating women
  • Prisoner
  • Unable to follow up for 12 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

University of Florida Gainesville

Gainesville, Florida, United States, 32607

Actively Recruiting

2

Florida Orthopaedic Institute

Temple Terrace, Florida, United States, 33637

Actively Recruiting

3

Atrium Health Navicent

Macon, Georgia, United States, 31201

Actively Recruiting

4

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

5

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States, 27546

Actively Recruiting

6

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States, 28203

Actively Recruiting

7

Atrium Health Cabarrus

Concord, North Carolina, United States, 28025

Actively Recruiting

8

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

9

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

10

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Actively Recruiting

11

University of Texas Houston

Houston, Texas, United States, 77030

Actively Recruiting

12

San Antonio Military Medical Center

San Antonio, Texas, United States, 78234

Actively Recruiting

13

Carilion Clinic

Roanoke, Virginia, United States, 24016

Not Yet Recruiting

14

Valley Health System

Winchester, Virginia, United States, 22601

Actively Recruiting

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Research Team

R

Rachel Seymour, PhD

CONTACT

C

Christine Churchill, MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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