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Next Generation Sequencing for Surgical Site Infection After Fracture Fixation

This study is looking at a new way to treat serious infections that can happen after surgery to fix a broken bone. These infections can cause a lot of problems, including long recovery times and more surgeries. The current tests often miss some bacteria, making treatment less effective. This study will use "Next Generation Sequencing" (NGS) to identify all bacteria causing the infection. If you are between 18 and 84 years old, have had surgery for a broken bone in your arm or leg, and developed a deep infection afterward, you might be able to join. The goal is to see if using NGS to guide antibiotic treatment can reduce the number of times treatment fails over 12 months.

Study design
This interventional study plans to enroll 250 participants. It will test a new diagnostic approach using Next Generation Sequencing.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to measure the infection treatment failure rate.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07458230

Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:

Not Yet Recruiting
PHASE3Ages 18–84InterventionalTreatment
Johns Hopkins Bloomberg School of Public Health
~250 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:NGS diagnostic findings

At a glance

Recruiting sites
0 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Infection treatment failure rate
Measured over 12 month

Conditions

Next Generation Sequencing (NGS)
Surgical Site Infection (SSI)
Fracture Fixation

Explore related trials

FractureSurgical Wound Infection

Where it's being run

18 sites across 16 states
California2
Virginia2
Alabama1
Illinois1
Indiana1
Maryland1
Mississippi1
New Hampshire1

Study leadership

  • Roman M Natoli, MD · PRINCIPAL_INVESTIGATOR · Indiana University, Methodist Hospital

Who to contact

Research Project Director
[email protected]
317-944-9400
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age 18-84 years
History of extremity fracture proximal to the metatarsals and carpal bones treated with any type of internal fixation. Note that both healed and unhealed fractures are eligible.
Deep infection requiring surgery after fracture fixation as determined by either of the following:
Plan for treatment includes antibiotic therapy prescribed by Infectious Disease provider(s), regardless of SOCHB culture or NGS results.

Exclusion

Spine fractures
High risk of amputation based on the initial managing physician opinion
Incarcerated/institutionalized
Patient is too sick to have surgery, i.e., medical co-morbidities which preclude treatment with a general anesthetic
Prior history of chronic infection at the surgical site
Pathological fractures from a neoplastic process
History of Paget's Disease
Unavailable for the planned 12 months of follow-up (e.g., planned follow-up at a location other than one of the study sites)
Extremity fracture occurred more than 2 years prior to the hospital admission for the presenting infection

What this trial measures

  • Infection treatment failure rate12 month

    Infection treatment failure rate, defined as unplanned return to the operating room for infection after randomization. Infection at this time will be similarly defined as in the inclusion criteria, namely FRI confirmatory criteria and/or, CDC criteria (without the timeframe). This includes the possibility of culture negative infection but determined to be infection by the treatment team.