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NCT07458230 · ClinicalTrials.gov registry record · Phase 3
Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
A Phase 3 study, sponsored by Johns Hopkins Bloomberg School of Public Health.
- Not yet
- Registry status
- Phase 3
- Development phase
- 250
- Enrollment target
NCT07458230 is a Phase 3 study that has not yet begun recruiting, run by Johns Hopkins Bloomberg School of Public Health. The registered enrollment target is 250 participants.
The verdict
NCT07458230, a Phase 3 study, has not yet begun recruiting, sponsored by Johns Hopkins Bloomberg School of Public Health.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 250 participants
- Enrollment target
Study Summary
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 bas
Interventions
- DIAGNOSTIC_TEST NGS diagnostic findings
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2026-10-01 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07458230
The ClinicalTrials.gov registry entry for NCT07458230 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins Bloomberg School of Public Health, which has 187 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which NGS diagnostic findings is the first listed.
NCT07458230 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07458230 about?
NCT07458230 is a clinical study titled "Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:". 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 infe...
What is the current status of trial NCT07458230?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 250 participants. The study started on 2026-10-01. Estimated completion is 2028-10-01.
What interventions are being tested in trial NCT07458230?
The interventions under investigation include: NGS diagnostic findings (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07458230?
This trial is sponsored by Johns Hopkins Bloomberg School of Public Health, which has 187 total clinical trials registered on ClinicalTrials.gov.
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