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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 84 Years

Healthy Volunteers

Not accepted

Interventions

• NGS diagnostic findings — DIAGNOSTIC_TEST
  Patient will receive antibiotic treatment and course using the NGS results. the investigators will require antibiotic treatment of any NGS finding that is not treated based on the results of SOCHB culture alone. Site PIs have agreed to integrate NGS results into the treatment plan. If the antibiotic plan contradicts the NGS-based results, alternative antibiotic selection and reason (e.g., allergy to an antibiotic, cost-prohibitive) will be documented in specific CRFs. All other treatments will be per SOC.

Study Details

The study focuses on the serious problem of infections and wound-healing issues that can happen after high-energy bone fractures. These complications are common and can affect between 10% and 60% of patients, especially those with severe injuries. When a fracture is repaired with surgery and an infection develops afterward, patients often face long recovery times, more pain, and sometimes multiple surgeries. In the worst cases, the infection can lead to permanent disability or even amputation. The current standard test used in hospitals, called a culture, often misses certain bacteria, which can make treatment less effective. Because of this, the study aims to find out whether adding a newer test called Next Generation Sequencing (NGS) can help doctors identify infections more accurately and improve patient outcomes. The main goal of the study is to see whether using NGS along with standard hospital cultures reduces the number of treatment failures compared to using standard cultures alone. Treatment failure means the infection does not get better and the patient must return to the operating room. The study also wants to learn whether NGS helps doctors make better antibiotic choices and avoid unnecessary or ineffective treatments. Another goal is to understand which NGS results are most helpful when doctors decide to change a patient's antibiotics. By learning this, researchers hope to create a model that explains how NGS information influences treatment decisions. To join the study, patients must be between 18 and 84 years old and have a deep infection after a fracture was repaired with internal fixation, such as plates, screws, or rods. Patients must also meet infection criteria from either the Fracture-Related Infection (FRI) guidelines or the CDC's infection criteria. A total of 250 patients will be randomly placed into one of two groups: one group will receive treatment guided by both NGS and standard cultures, while the other group will receive treatment based only on standard cultures. Researchers will then compare how often treatment fails in each group. Treatment failure includes several possible outcomes. The most important is an unplanned return to the operating room because the infection did not improve. Other types of failure include new superficial infections that do not require surgery, bones that fail to heal properly (called nonunion), amputation, and complications caused by antibiotics. Patients will return for follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 12 months after joining the study so researchers can track the patient's progress and monitor for any problems. Right now, the failure rate for treating these infections using standard hospital cultures is about 30%, which is considered unacceptably high. The researchers believe that adding NGS will help lower this number because NGS can detect more types of bacteria, including ones that are hard to grow in a lab. With better information, doctors can choose antibiotics that are more likely to work the first time, which may reduce the need for additional surgeries and improve healing. This could be especially important for military service members, who often suffer high-energy injuries and face a greater risk of long-term complications if treatment fails. NGS is already available, covered by Medicare, and fast enough to be useful in real-time medical decisions. If this study shows that NGS improves treatment outcomes, hospitals could begin using it widely and quickly. The researchers hope that this approach will lead to fewer infections, better antibiotic use, faster recovery, and improved long-term function for patients.

Key Dates

Start date

Jul 1, 2026

Status verified

May 2026

Primary completion

Oct 1, 2028

Completion

Oct 1, 2028

Study Design

Enrollment

250 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• No Intervention: Standard of Care (Control)
  Participants in this group will receive standard of care treatment for FRI. The care team will Not be provided with NGS data. Treatment strategy will be entirely based on SOCHB culture assessment strategies.
• Experimental: Diagnostic Test: NGS diagnostic findings
  Patient will receive antibiotic treatment and course using the NGS results. The clinical care team will be provided with NGS diagnostic findings along with SOCHB culture data.

Primary Outcome Measure

Infection treatment failure rate [ Time Frame: 12 month ]

Central Contacts

• Research Project Director
  317-944-9400
  [email protected]
• Clinical Research Manager
  317-944-9400
  [email protected]

Locations (18)

Find similar trials in Tuscaloosa, AL

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