{"id":"nct:NCT07458230","kind":"trial","title":"Efficacy of Integrating Next Generation Sequencing for Treatment of Surgical Site Infection After Fracture Fixation:","authors":["Johns Hopkins Bloomberg School of Public Health"],"author_count":1,"year":2026,"published":"2026-03-09","venue":"ClinicalTrials.gov","cited_by":null,"doi":null,"arxiv_id":null,"nct_id":"NCT07458230","source_url":"https://clinicaltrials.gov/study/NCT07458230","archive_url":"https://space-kitty.com/papers/nct:NCT07458230","updated":"2026-10-08","pmid":null,"pmcid":null,"openalex_id":null,"pdf_url":null,"abstract":"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…","abstract_license":"ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters","license":"ClinicalTrials.gov terms (attribution, processing date, modifications noted)","is_open_access":true,"retracted":false,"peer_reviewed":null,"categories":["Next Generation Sequencing (NGS)","Surgical Site Infection (SSI)","Fracture Fixation"],"details":{"acronym":"NGS","status":"NOT_YET_RECRUITING","phase":"PHASE3","study_type":"INTERVENTIONAL","enrollment":250,"sponsor":"Johns Hopkins Bloomberg School of Public Health","conditions":["Next Generation Sequencing (NGS)","Surgical Site Infection (SSI)","Fracture Fixation"],"interventions":["DIAGNOSTIC_TEST: NGS diagnostic findings"],"start_date":"2026-11-01","start_date_type":"ESTIMATED","primary_completion_date":"2028-10-01","has_results":false,"data_source":"ClinicalTrials.gov","data_processed":"2026-10-29T09:00:05","modifications":"selected fields only; whitespace normalized; brief summary truncated to 2,000 characters"},"provenance":"clinicaltrials","attribution":"Source: ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters. Not a U.S. Government endorsement.","topics":[{"slug":"infectious-disease-amr","name":"Infectious Disease, Vaccines & Antimicrobial Resistance","domain_slug":"medicine"}],"cited_in_dossiers":[]}