Recruiting

Antibiotic Coated Nail

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05421741

Conditions

Osteomyelitis Tibia

Tibial Fractures

Open Tibia Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Antibiotic coated intramedullary Nail

Standard Intramedullary Nail

Study Details

Brief summary:

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 ID

NCT05421741

Start date

May 15, 2023

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

242 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Intramedullary Nail

Traditional standard of care intramedullary (IM) nail

active comparator: Antibiotic Coated Intramedullary Nail

Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid.

Interventions

Antibiotic coated intramedullary Nail

Antibiotic coated intramedullary nail:

A mixture of 40gm bag of acrylic cement, antibiotic powder (Vancomycin 2gm) and 560mg gentamicin liquid. The intramedullary is coated with the mixture using a cement gun tube.

Standard Intramedullary Nail

Standard Intramedullary Nail

Primary outcome measure

  • Number of Participants who develop deep surgical site infection (SSI) [ Time Frame: Day 30 through month 12 ]

Central Contacts and Locations

Central contacts

Rachel Seymour, PhD

7043552000Rachel.Seymour@advocatehealth.org

Christine Churchill, MA

7043552000Christine.Churchill@advocatehealth.org

Locations

University of Florida Gainesville

Recruiting

Gainesville, Florida, United States, 32607

Florida Orthopaedic Institute

Recruiting

Temple Terrace, Florida, United States, 33637

Principal Investigator:

Hassan Mir, MD

Atrium Health Navicent

Recruiting

Macon, Georgia, United States, 31201

Principal Investigator:

Jarrod Dumpe, MD

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Ashley Mayo

773-906-4605ashley.mayo@bsd.uchicago.edu

Principal Investigator:

Brianna Fram, MD

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40536

Principal Investigator:

Paul Matuszewski, MD

University of North Carolina Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27546

Atrium Health Carolinas Medical Center

Recruiting

Charlotte, North Carolina, United States, 28203

Principal Investigator:

Joseph R Hsu, MD

Atrium Health Cabarrus

Recruiting

Concord, North Carolina, United States, 28025

Principal Investigator:

Luke Harmer, MD

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Principal Investigator:

Eben Carroll, MD

Penn State Milton S. Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033

Contacts

Jana Davis, MD

jdavis25@pennstatehealth.psu.edu

Uzma Muzammil

umuzammil@pennstatehealth.psu.edu

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37232

Principal Investigator:

Daniel Stinner, MD

University of Texas Houston

Recruiting

Houston, Texas, United States, 77030

San Antonio Military Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Principal Investigator:

Raymond Kessler, MD

Valley Health System

Recruiting

Winchester, Virginia, United States, 22601

Contacts

Kenneth Nelson, MD

skiarmy@yahoo.com

Ashley Zelaski

azelaski2@valleyhealthlink.com

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Aug 18, 2026

Last verified

May, 2026

Keywords

  • Antibiotic-coated nail

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-08-18.