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NCT05421741RECRUITINGIRB Ready

Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Sponsored by Wake Forest University Health Sciences

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
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1 of 484 participants interested
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Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

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
Unable to follow up for 12 months

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

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Target Enrollment

484 participants

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Gender

ALL

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Sponsor

Wake Forest University Health Sciences

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Gainesville

Florida

Location available
View Gainesville location page
RECRUITING

Temple Terrace

Florida

Location available
View Temple Terrace location page
RECRUITING

Macon

Georgia

Location available
View Macon location page
RECRUITING

Lexington

Kentucky

Location available
View Lexington location page
RECRUITING

Chapel Hill

North Carolina

Location available
View Chapel Hill location page
RECRUITING

Charlotte

North Carolina

Location available
View Charlotte location page
RECRUITING

Concord

North Carolina

Location available
View Concord location page
RECRUITING

Winston-Salem

North Carolina

Location available
View Winston-Salem location page
RECRUITING

Hershey

Pennsylvania

Location available
View Hershey location page

๐Ÿ“ And 5 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Tibia fracture Treatment in Gainesville?

Join others in Florida exploring innovative treatment options through clinical research

Tibia fracture Treatment Options in Gainesville, Florida

If you're searching for Tibia fracture treatment in Gainesville, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Gainesville, Temple Terrace, Macon and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Tibia fracture. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Florida
Now Enrolling
Up to 484 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Tibia fracture?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Tibia fracture

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Tibia fracture Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05421741. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.