Prophylactic Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

May 10, 2024 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

484

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • University of Florida Gainesville
        • Contact:
          • Michael Talerico, MD
        • Contact:
          • Marissa Pazik
      • Temple Terrace, Florida, United States, 33637
        • Recruiting
        • Florida Orthopaedic Institute
        • Principal Investigator:
          • Hassan Mir, MD
        • Contact:
          • Lisa Stang
    • Georgia
      • Macon, Georgia, United States, 31201
        • Not yet recruiting
        • Atrium Health Navicent
        • Contact:
          • Jarrod Dumpe, MD
        • Principal Investigator:
          • Jarrod Dumpe, MD
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky
        • Contact:
          • Paul Matuszewski, MD
        • Principal Investigator:
          • Paul Matuszewski, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Louisiana State University - University Medical Center New Orleans
        • Contact:
          • Carolyn Bridgman
        • Principal Investigator:
          • Jessica Rivera, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27546
        • Not yet recruiting
        • University of North Carolina Chapel Hill
        • Contact:
          • Andrew Chen, MD
        • Contact:
          • Malvika Choudhari
      • Charlotte, North Carolina, United States, 28203
        • Recruiting
        • Atrium Health Carolinas Medical Center
        • Contact:
          • Rachel B Seymour, PhD
        • Contact:
          • Christine Churchill, MA
        • Principal Investigator:
          • Joseph R Hsu, MD
        • Sub-Investigator:
          • Rachel B Seymour, PhD
        • Sub-Investigator:
          • Madhav Karunakar, MD
        • Sub-Investigator:
          • Stephen Sims, MD
        • Sub-Investigator:
          • Kevin Phelps, MD
        • Sub-Investigator:
          • Laurence Kempton, MD
        • Sub-Investigator:
          • Meghan Wally, PhD
        • Sub-Investigator:
          • Susan Odum, PhD
      • Concord, North Carolina, United States, 28025
        • Recruiting
        • Atrium Health Cabarrus
        • Contact:
          • Luke Harmer, MD
        • Contact:
          • Erica Grochowski, MPH
        • Principal Investigator:
          • Luke Harmer, MD
        • Sub-Investigator:
          • Laura Blum, MD
      • Winston-Salem, North Carolina, United States, 27157
        • Not yet recruiting
        • Atrium Health Wake Forest Baptist
        • Contact:
          • Martha Holden
        • Principal Investigator:
          • Eben Carroll, MD
    • Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Karen Trochez
        • Principal Investigator:
          • Daniel Stinner, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Houston
        • Contact:
          • Stephen Warner, MD
        • Contact:
          • Natasha Howard
      • San Antonio, Texas, United States, 78234
        • Recruiting
        • San Antonio Military Medical Center
        • Contact:
          • Raymond Kessler, MD
        • Principal Investigator:
          • Raymond Kessler, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Not yet recruiting
        • Inova
        • Principal Investigator:
          • Greg Gaski, MD
        • Contact:
          • Mohamad Ray-Zack
      • Winchester, Virginia, United States, 22601

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intramedullary Nail
Traditional standard of care intramedullary (IM) nail
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants who develop deep surgical site infection (SSI)
Time Frame: Day 30 through month 12
Number of participants in each group who develop SSI as defined by the criteria establish by the Centers for Disease Control and Prevention (CDC). The CDC criteria define deep as occurring within 30 or 90 days after the procedure. However, we will continue to follow patients for 12 months and document any infections and other complications during this period.
Day 30 through month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic Union Scale in Tibial fractures (RUST) score
Time Frame: week 6, month 3, month 6, and month 12
The RUST score ranges from a minimum score of 4 (definitely not healed) to a maximum score of 12 (completely healed). The final x-ray obtained within a 12-month period following injury will be uploaded to REDCap for review by a blinded panel of investigators from participating sites.
week 6, month 3, month 6, and month 12
Percentage of Union
Time Frame: week 6, month 3, month 6 and month12
Union is the gradual process of bone regeneration after a fracture. Percentage of Union, as determined by the treating surgeon, will be assessed via radiographs. Recorded by surgeon as yes/no answers.
week 6, month 3, month 6 and month12
Time to Union
Time Frame: week 6, month 3, month 6 and month12
Captured in days
week 6, month 3, month 6 and month12
Average Time to Return to Work/Duty
Time Frame: week 6, month 3, month 6 and month12
number of days
week 6, month 3, month 6 and month12
International Physical Activity Questionnaire (IPAQ)
Time Frame: week 6, month 3, month 6 and month12

IPAQ measures the total amount of physical activity completed in a 7 day period by calculating the minutes per week in in each physical activity level domain (walking, moderate and vigorous) by a metabolic equivalent energy (MET) expenditure estimate.

Walking = 3.3 x number of walking minutes x number of walking days Moderate activity= 4.0 x number activity minutes x number of days Vigorous activity = 8 x number of activity minutes x number of days Total = Walking MET-min/wk+moderate MET-min/wk+vigorous MET-min/wk
week 6, month 3, month 6 and month12
Number of Subjects Who Have Returned to Work
Time Frame: week 6, month 3, month 6 and month12
Determined by asking whether subjects have returned to work
week 6, month 3, month 6 and month12
Number of Participants who Return to Operating Room (OR)
Time Frame: Month 12
Month 12
PROMIS-29 Subscale--Physical Function
Time Frame: week 6, month 3, month 6 and month12
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means higher physical function.
week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Physical Function: Anxiety
Time Frame: week 6, month 3, month 6 and month12
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of anxiety.
week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Depression
Time Frame: week 6, month 3, month 6 and month12
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of depression.
week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Fatigue
Time Frame: week 6, month 3, month 6 and month12
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of fatigue.
week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Sleep Disturbance
Time Frame: week 6, month 3, month 6 and month12
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of sleep disturbance.
week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Pain Interference
Time Frame: week 6, month 3, month 6 and month12
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher level of pain interference.
week 6, month 3, month 6 and month12
PROMIS-29 Subscale--Ability to Participate in Social Roles and Activities
Time Frame: week 6, month 3, month 6 and month12
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means a higher ability to participate in social roles and activities.
week 6, month 3, month 6 and month12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Joseph Hsu, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 13, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00086285
  • 01012022 (Other Identifier: Atrium Health)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tibial Fractures

Clinical Trials on Standard Intramedullary Nail

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe