Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Intramedullary Nail 		Traditional standard of care intramedullary (IM) nail
  • Drug: 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.
    Other names:
    • Local Gentamicin 560 Powder
    • Vancomycin 2gm Liquid
  • Other: Standard Intramedullary Nail
    Standard Intramedullary Nail
Active Comparator
Antibiotic Coated Intramedullary Nail 		Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid.
  • Drug: 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.
    Other names:
    • Local Gentamicin 560 Powder
    • Vancomycin 2gm Liquid

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40536
Contact:
Paul Matuszewski, MD

More Details

NCT ID
NCT05421741
Status
Recruiting
Sponsor
Wake Forest University Health Sciences

Study Contact

Rachel Seymour, PhD
7043552000
Rachel.Seymour@atriumhealth.org

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).