Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

NCT ID: NCT05421741

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 484 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-15
• Study Completion Date: 2027-12-31

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.

Detailed 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).

Conditions

Osteomyelitis Tibia; Tibial Fractures; Open Tibia Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intramedullary Nail

Traditional standard of care intramedullary (IM) nail

Group Type: ACTIVE_COMPARATOR

Standard Intramedullary Nail

Intervention Type: OTHER

Standard Intramedullary Nail

Antibiotic Coated Intramedullary Nail

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

Group Type: ACTIVE_COMPARATOR

Antibiotic coated intramedullary Nail

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

Standard Intramedullary Nail

Standard Intramedullary Nail

Intervention Type: OTHER

Other Intervention Names

Local Gentamicin 560 Powder; Vancomycin 2gm Liquid

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

University of Florida Gainesville

Gainesville, Florida, United States

Site Status: RECRUITING

Florida Orthopaedic Institute

Temple Terrace, Florida, United States

Site Status: RECRUITING

Atrium Health Navicent

Macon, Georgia, United States

Site Status: RECRUITING

University of Kentucky

Lexington, Kentucky, United States

Site Status: RECRUITING

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Atrium Health Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status: RECRUITING

Atrium Health Cabarrus

Concord, North Carolina, United States

Site Status: RECRUITING

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status: RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status: RECRUITING

University of Texas Houston

Houston, Texas, United States

Site Status: RECRUITING

San Antonio Military Medical Center

San Antonio, Texas, United States

Site Status: RECRUITING

Carilion Clinic

Roanoke, Virginia, United States

Site Status: NOT_YET_RECRUITING

Valley Health System

Winchester, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Seymour, PhD

Role: CONTACT

Rachel.Seymour@atriumhealth.org

7043552000

Christine Churchill, MA

Role: CONTACT

Christine.Churchill@atriumhealth.org

7043552000

Facility Contacts

Michael Talerico, MD

Role: primary

Marissa Pazik

Role: backup

Lisa Stang

Role: primary

Jarrod Dumpe, MD

Role: primary

Paul Matuszewski, MD

Role: primary

Andrew Chen, MD

Role: primary

Malvika Choudhari

Role: backup

Rachel B Seymour, PhD

Role: primary

Christine Churchill, MA

Role: backup

Luke Harmer, MD

Role: primary

Erica Grochowski, MPH

Role: backup

Martha Holden

Role: primary

Jana Davis, MD

Role: primary

jdavis25@pennstatehealth.psu.edu

Uzma Muzammil

Role: backup

umuzammil@pennstatehealth.psu.edu

Karen Trochez

Role: primary

Stephen Warner, MD

Role: primary

Natasha Howard

Role: backup

Raymond Kessler, MD

Role: primary

Cody Evans, MD

Role: primary

clevans@carilionclinic.org

540-510-6200

Kenneth Nelson, MD

Role: primary

skiarmy@yahoo.com

Ashley Zelaski

Role: backup

azelaski2@valleyhealthlink.com

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Other Identifiers

01012022

Identifier Type: OTHER

Identifier Source: secondary_id

40010222

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00086285

Identifier Type: -

Identifier Source: org_study_id