Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Last updated: June 2, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

4

Condition

Osteomyelitis

Treatment

Antibiotic coated intramedullary Nail

Standard Intramedullary Nail

Clinical Study ID

NCT05421741
IRB00086285
01012022
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients 18 years or older

  • Gustilo Type II or III open tibia fracture requiring definitive fixation withintramedullary nail

Exclusion

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

Total Participants: 484
Treatment Group(s): 2
Primary Treatment: Antibiotic coated intramedullary Nail
Phase: 4
Study Start date:
May 15, 2023
Estimated Completion Date:
December 31, 2027

Study Description

Despite significant treatment advances and protocols to prevent infection, severe open fractures of the lower extremity still have very high rates of deep infection. Infection in an active duty military population increases disability and decreases the likelihood of returning to duty. In addition, infection is one of the main factors associated with rehospitalization. Further, deep infections have not only resulted in increased disability after injury, infection is implicated as one of the main factors in late amputation. Among service members, only 20-25% with a severe open tibia fracture are able to return to active duty. Novel techniques for reducing infection are needed. The proposed study addresses the focus area of fracture-related infections, specifically the prevention of infection.

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.

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.

The target population for the proposed study is patients with severe open tibia fractures (Type II or Type III) who require definitive fixation with intramedullary nail recruited from one of the participating sites during the index hospitalization.

One group will be treated prophylactically using an antibiotic coated intramedullary nail at time of definitive fixation (1CN), while the second group will be treated with traditional standard of care intramedullary nail without antibiotic-coating (SN).

Participant will be followed for 12 months (data capture including patient interviews and clinical data capture from the treatment team and medical record at baseline, 6 weeks, 3 months, 6 months, and 12 months).

Connect with a study center

  • University of Florida Gainesville

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Florida Orthopaedic Institute

    Temple Terrace, Florida 33637
    United States

    Active - Recruiting

  • Medical College of Georgia

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Atrium Health Navicent

    Macon, Georgia 31201
    United States

    Active - Recruiting

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Active - Recruiting

  • Louisiana State University - University Medical Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina 27546
    United States

    Active - Recruiting

  • Atrium Health Carolinas Medical Center

    Charlotte, North Carolina 28203
    United States

    Active - Recruiting

  • Atrium Health Cabarrus

    Concord, North Carolina 28025
    United States

    Active - Recruiting

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • The University of Texas Medical Branch

    Galveston, Texas 77555
    United States

    Site Not Available

  • University of Texas Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • San Antonio Military Medical Center

    San Antonio, Texas 78234
    United States

    Active - Recruiting

  • Inova

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Carilion Clinic

    Roanoke, Virginia 24016
    United States

    Site Not Available

  • Valley Health System

    Winchester, Virginia 22601
    United States

    Active - Recruiting

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