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Anti-infective Agent

Antibiotic Coated Nail for Preventing Infection in Broken Bones

Phase 4
Recruiting
Led By Joseph Hsu, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Gustilo Type II or III open tibia fracture requiring definitive fixation with intramedullary nail
Be older than 18 years old
Must not have
Unable to speak English or Spanish
Less than 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6, month 3, month 6 and month12
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare outcomes of patients treated with a prophylactic antibiotic coated nail vs. traditional IM nailing.

Who is the study for?
This trial is for adults with a type II or III open tibia fracture needing a nail implant to fix the bone. Participants must be able to follow up for a year and speak English or Spanish. It's not for those under 18, allergic to vancomycin/gentamicin, pregnant/lactating women, prisoners, or unable to commit.
What is being tested?
The study compares two treatments: one uses an antibiotic-coated nail designed to prevent infection after surgery; the other uses a standard intramedullary nail without antibiotics. Patients are randomly assigned to either group.
What are the potential side effects?
Potential side effects may include reactions at the site of surgery related to the materials used in nails such as pain, swelling, and possible allergic reaction if sensitivity exists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a severe open fracture in my shin that needs surgery with a metal rod.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot speak English or Spanish.
Select...
I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6, month 3, month 6 and month12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6, month 3, month 6 and month12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Communicable Diseases
Secondary study objectives
Average Time to Return to Work/Duty
International Physical Activity Questionnaire (IPAQ)
Number of Subjects Who Have Returned to Work
+10 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Intramedullary NailActive Control1 Intervention
Traditional standard of care intramedullary (IM) nail
Group II: Antibiotic Coated Intramedullary NailActive Control1 Intervention
Intramedullary Nail coated with 2 grams of vancomycin and 560 mg gentamicin liquid.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,403 Previous Clinical Trials
2,477,851 Total Patients Enrolled
Joseph Hsu, MDPrincipal InvestigatorWake Forest University Health Sciences
4 Previous Clinical Trials
620 Total Patients Enrolled

Media Library

Antibiotic coated intramedullary Nail (Anti-infective Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05421741 — Phase 4
Tibial Fracture Research Study Groups: Intramedullary Nail, Antibiotic Coated Intramedullary Nail
Tibial Fracture Clinical Trial 2023: Antibiotic coated intramedullary Nail Highlights & Side Effects. Trial Name: NCT05421741 — Phase 4
Antibiotic coated intramedullary Nail (Anti-infective Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05421741 — Phase 4
~265 spots leftby Dec 2026
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