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Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

NCT05421741 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 484

Last updated 2026-03-18

No results posted yet for this 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.

Conditions

  • Osteomyelitis Tibia
  • Tibial Fractures
  • Open Tibia Fracture

Interventions

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

Standard Intramedullary Nail

Standard Intramedullary Nail

Sponsors & Collaborators

  • Wake Forest University Health Sciences

    lead OTHER

Principal Investigators

  • Joseph Hsu, MD · Wake Forest University Health Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05421741 on ClinicalTrials.gov