Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:
NGS
2 other identifiers
interventional
250
1 country
18
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2026
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2026
CompletedFirst Posted
Study publicly available on registry
March 9, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2028
Study Completion
Last participant's last visit for all outcomes
October 1, 2028
May 8, 2026
May 1, 2026
2.3 years
March 3, 2026
May 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Infection treatment failure rate
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.
12 month
Study Arms (2)
Standard of Care (Control)
NO INTERVENTIONParticipants 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.
Diagnostic Test: NGS diagnostic findings
EXPERIMENTALPatient 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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:
- FRI confirmatory criteria CDC criteria (without the timeframe). This includes the possibility of culture negative infection but determined to be infection by treatment team.
- Plan for treatment includes antibiotic therapy prescribed by Infectious Disease provider(s), regardless of SOCHB culture or NGS results.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
University of Alabama
Tuscaloosa, Alabama, 35487, United States
University of Southern California
Los Angeles, California, 90007, United States
UCSF Medical Center
San Francisco, California, 94143, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Methodist Hospital
Indianapolis, Indiana, 46202, United States
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Ohio State University Hospital
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Warren Alpert Medical School of Brown University
Providence, Rhode Island, 02903, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
McGovern Medical School at UTHealth Houston
Houston, Texas, 77030, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
UVA Health University Medical Center
Charlottesville, Virginia, 22908, United States
Inova Fairfax Medical Campus
Fairfax, Virginia, 22042, United States
UW Health University Hospital
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roman M Natoli, MD
Indiana University, Methodist Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Masking Details
- NGS results withheld from care team in one arm
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2026
First Posted
March 9, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
October 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
May 8, 2026
Record last verified: 2026-05