Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04597008
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : July 2, 2021
Sponsor:
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The overall objective is to compare the effect of Vancomycin and Tobramycin powder combined (treatment) to Vancomycin powder (control) in the reduction of post-fixation infections of tibial plateau and tibial pilon fractures at high risk of infection (collectively considered the "study injuries").

Condition or disease Intervention/treatment Phase
Post Operative Surgical Site Infection Drug: Treatment group Drug: Control group Phase 3

Detailed Description:

Specific Aim 1: Compare the proportion of deep surgical site infections (SSI) of the study injury within 365 days of definitive fracture fixation surgery in patients allocated to receive a combination of local Vancomycin and Tobramycin powders compared to patients allocated to local Vancomycin powder.

Sensitivity Analyses: A series of sensitivity analyses will be conducted to look at alternative measures of deep SSI under Specific Aim 1. These sensitivity analyses will consider the following alternative end points of deep SSI: infection by gram-negative bacteria, infection by gram-positive bacteria, polymicrobial pathogenic infections, culture negative infections, and cellulitis/skin infections.

Specific Aim 2: To compare the safety of treatment with a combination of local Vancomycin and Tobramycin versus Vancomycin powder alone as measured by the proportion of antibiotic resistance in each arm.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA - A Multicenter Randomized Controlled Trial
Actual Study Start Date : May 11, 2021
Estimated Primary Completion Date : May 11, 2023
Estimated Study Completion Date : May 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Control
Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed immediately before wound closure.
 Drug: Control group
Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed immediately before wound closure.
Other Name: Control
Experimental: Treatment
Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed immediately before wound closure.
 Drug: Treatment group
Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed immediately before wound closure.
Other Name: Treatment


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Deep Surgical Site Infection (SSI) [ Time Frame: within 365 days of definitive fracture fixation surgery ]
    Compare the proportion of deep SSIs of the study injury within 365 days of definitive fracture fixation surgery in patients treated with local Vancomycin powder compared to those treated with a combination of local Vancomycin and Tobramycin powders. For this study a "deep SSI" is a SSI that is treated with operative debridement. In the current CDC terminology this would include all deep organ space, deep incisional, and superficial infections that are treated with surgery.


Secondary Outcome Measures :
  1. Sensitivity analyses [ Time Frame: within 365 days of definitive fracture fixation surgery ]
    These sensitivity analyses will consider the following alternative end points of deep SSI: infection by gram-negative bacteria, infection by gram-positive bacteria, polymicrobial pathogenic infections, culture negative infections, and cellulitis/skin infections.

  2. Antibiotic resistance [ Time Frame: within 365 days of definitive fracture fixation surgery ]
    To compare the safety of treatment with a combination of local Vancomycin and Tobramycin versus Vancomycin powder alone as measured by the proportion of antibiotic resistance in each arm.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Tibial plateau or tibial pilon fractures that is treated operatively with plate and screw fixation AND at least one of the following characteristics indicative of higher risk of infection:

    1. Initially treated with an external fixation and treated definitively more than 3 days later after swelling has resolved.
    2. Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
    3. Tibia fracture is associated with ipsilateral leg compartment syndrome and fasciotomy wounds.
  2. Patients ages 18 through 80 years.

Exclusion Criteria:

  1. Study injury is already infected at time of study enrollment.
  2. Definitive fixation of the study injury prior to enrollment in the study.
  3. The patient never receives study fixation.
  4. Massive myonecrosis from ipsilateral leg compartment syndrome.
  5. Currently pregnant.
  6. Severe problems with maintaining follow-up (e.g. patients who are homeless at the time of injury, those who are intellectually challenged without adequate family support, or are unwilling to provide phone and address contact information).
  7. Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome).
  8. Patients with allergies, drug administration reactions, or other sensitivities to Tobramycin or other aminoglycosides.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04597008


Contacts
Layout table for location contacts
Contact: Suna Chung, MPH 410-502-3357 schung60@jhu.edu
Contact: Susan C Collins, MSc 410-502-8966 scolli21@jhu.edu

Locations
Layout table for location information
United States, Maryland
University of Maryland Shock Trauma Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Joshua Gary         
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
Investigators
Layout table for investigator information
Principal Investigator: Robert V O'Toole, MD, MS University of Maryland, Department of Orthopaedic Trauma
Principal Investigator: Renan C Castillo, PhD Johns Hopkins Bloomberg School of Public Health
Study Director: Anthony R Carlini, MS Johns Hopkins Bloomberg School of Public Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier: NCT04597008    
Other Study ID Numbers: W81XWH-19-1-0848
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: July 2, 2021
Last Verified: July 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Major Extremity Trauma Research Consortium:
Surgical site infection risk prevention
Bacterial species type and antibacterial sensitivities
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Surgical Wound Infection
Disease Attributes
 Pathologic Processes
Wound Infection
Postoperative Complications