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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6, month 3, month 6 and month12
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Communicable Diseases
Secondary outcome measures
Average Time to Return to Work/Duty
International Physical Activity Questionnaire (IPAQ)
Number of Participants who Return to Operating Room (OR)
+11 more

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
1,234 Previous Clinical Trials
1,001,424 Total Patients Enrolled
Joseph Hsu, MDPrincipal InvestigatorWake Forest University Health Sciences
3 Previous Clinical Trials
600 Total Patients Enrolled

Media Library

Antibiotic coated intramedullary Nail (Anti-infective Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05421741 — Phase 4
Open Tibia Fracture Research Study Groups: Intramedullary Nail, Antibiotic Coated Intramedullary Nail
Open Tibia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At what number of sites is this trial currently taking place?

"Currently, the trial is recruiting out of nine facilities scattered across Fairfax, Temple Terrace and Winston-Salem. To reduce travel time for participants, it is advised to pick a location as close to you as possible."

Answered by AI

Are there any vacancies for participants in this research program?

"According to the details registered on clinicaltrials.gov, this medical experiment is not currently recruiting participants. It was initially posted in December 1st 2022 and last updated October 25th 2022. However, there are 362 other trials that are open for enrollment at present time."

Answered by AI

What potential risks accompany Antibiotic Coated Intramedullary Nail implementation?

"There is a significant amount of evidence in support of Antibiotic Coated Intramedullary Nail's safety, so it received the highest score possible (3)."

Answered by AI
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~323 spots leftby Dec 2026