AzTrials
AzTrials

Post Operative Surgical Site InfectionPhase 3TOBRANCT04597008

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

A Phase 3 study testing Treatment group in people with Post Operative Surgical Site Infection, run by Major Extremity Trauma Research Consortium at 41 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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"). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Post Operative Surgical Site Infection
What is being tested?
Treatment group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,660 participants
Where
41 sitesUnited States
Study dates
18 Jun 2021to 30 Jul 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Study injury is already infected at time of study enrollment.
  • Definitive fixation of the study injury prior to enrollment in the study.
  • The patient never receives study fixation.
  • Massive myonecrosis from ipsilateral leg compartment syndrome.
  • Currently pregnant.
  • 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).
  • Patients with allergies, drug administration reactions, or other sensitivities to Vancomycin (such as a history of Redman's Syndrome).
  • Patients with allergies, drug administration reactions, or other sensitivities to Tobramycin or other aminoglycosides.

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

United States41 sites

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

  • University of Maryland Shock Trauma Center

    Baltimore, Maryland, 21201

  • University of Maryland Shock Trauma/Capitol Regions

    Baltimore, Maryland, 21201

  • University of Alabama Heersink School of Medicine

    Birmingham, Alabama, 35205

  • Harvard/Mass General/Brigham Hospitals

    Boston, Massachusetts, 02115

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • Medical University of South Carolina -

    Charleston, South Carolina, 29425

  • Carolinas Medical Center/Atrium Health Musculoskeletal Health Institute

    Charlotte, North Carolina, 28203

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Loyola University Chicago

    Chicago, Illinois, 60153

  • METROHealth

    Cleveland, Ohio, 44109

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 43201

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75246

  • Inova Fairfax MEdical Campus

    Falls Church, Virginia, 22042

  • Core Well Health

    Grand Rapids, Michigan, 49503

  • Penn State College of Medicine

    Hershey, Pennsylvania, 17033

  • UTHealth/McGovern Medical School

    Houston, Texas, 77030

  • Indiana University School of Medicine - Methodist Hospital

    Indianapolis, Indiana, 46202

  • Indiana University/Eskenazi Health

    Indianapolis, Indiana, 46202

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Dartmouth Hitchcock

    Lebanon, New Hampshire, 03766

  • University of Kentucky

    Lexington, Kentucky, 40506

  • Keck School of Medicine of USC

    Los Angeles, California, 90033

  • University of Wisconsin

    Madison, Wisconsin, 53705

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • LSU Health Sciences

    New Orleans, Louisiana, 70112

  • New York Presbyterian/Hospital for Special Surgery

    New York, New York, 10021

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania Perelman School of Medicine

    Philadelphia, Pennsylvania, 19106

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Rhode Island Hospital/Brown University

    Providence, Rhode Island, 02905

  • Jamaica Hospital Medical Center

    Queens, New York, 11418

  • Stanford University

    Redwood City, California, 94063

  • Virginia Commonwealth University Medical Center

    Richmond, Virginia, 23298

  • University of Utah

    Salt Lake City, Utah, 84108

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • _University of California, San Francisco

    San Francisco, California, 94110

  • Cedars Sinai

    West Hollywood, California, 90069

  • St Mary's University/Tenent Health

    West Palm Beach, Florida, 33407

  • Atrium Health Wake Forest Baptist

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Topical Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: TOBRA - A Multicenter Randomized Controlled Trial

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").

Read the detailed description

Specific Aim 1: Compare the proportion of deep surgical site infections (SSI) of the study injury within 182 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 only gram-negative bacteria, infection by any gram-positive bacteria (with or without other organisms of any type), 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.

Being tested
Treatment group, Control group
Keywords
Surgical site infection risk prevention, Bacterial species type and antibacterial sensitivities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment groupDrug

    Also called 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, which is placed right before wound closure at the final stafe of definitive fracture fixation.

  • Control groupDrug

    Also called Control

    Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed, which is placed right before wound closure at the final stage of definitive fracture fixation.

Study groups in NCT04597008
Study groupRoleWhat they receive
ControlActive comparatorStandard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed, which is placed right before wound closure at the final stage of definitive fracture fixation.
Receives: Drug: Control group
TreatmentExperimentalStandard 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, which is placed right before wound closure at the final stafe of definitive fracture fixation.
Receives: Drug: Treatment group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Deep Surgical Site Infection (SSI)

    Compare the proportion of deep SSIs of the study injury within 182 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.

    Measured: within 182 days of definitive fracture fixation surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2020
  2. Study start18 Jun 2021
  3. Primary completion30 Jul 2025
  4. Study completion30 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,660 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04597008
Sponsor's protocol ID
W81XWH-19-1-0848
Acronym
TOBRA
Status last verified
May 2026
First submitted
15 Oct 2020
Last updated
22 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Schrank GM, O'Hara NN, Lee S, Degani Y, Chung S, Carlini AR, Castillo RC, O'Toole RV. Safety of topical tobramycin powder during operative treatment of fractures. J Antimicrob Chemother. 2025 Sep 3;80(9):2417-2420. doi: 10.1093/jac/dkaf230.

    PubMed 40667718

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Treatment group in people with Post Operative Surgical Site Infection, run by Major Extremity Trauma Research Consortium at 41 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Deep Surgical Site Infection (SSI) (time frame: within 182 days of definitive fracture fixation surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04597008, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in