Condition: Infections · Infected Wound · Nonunion of Fracture · Sponsor: Major Extremity Trauma Research Consortium
This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.
This description comes directly from the study's public registry record.
William Obremskey, MD · 615-260-2054 · william.obremskey@vumc.org
Karen Trochez · karen.m.trochez@vumc.org
Always discuss trial participation with your own doctor first.
| Indiana University | Indianapolis, Indiana, United States | Recruiting |
| University of Maryland , MD Department of Orthopaedics | Baltimore, Maryland, United States | Recruiting |
| Sinai Hospital Baltimore | Baltimore, Maryland, United States | Not Yet Recruiting |
| Hennepin Health | Minneapolis, Minnesota, United States | Recruiting |
| Jamaica Hospital Medical Center | Queens, New York, United States | Not Yet Recruiting |
| Atrium Health, Carolinas Medical Center | Charlotte, North Carolina, United States | Not Yet Recruiting |
| Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina, United States | Recruiting |
| University of Okalahoma College of Medicine | Oklahoma City, Oklahoma, United States | Not Yet Recruiting |
| Penn State University M.S. Hershey Medical Center | Hershey, Pennsylvania, United States | Recruiting |
| Vanderbilt Medical Center | Nashville, Tennessee, United States | Recruiting |
| University of Texas Health Science Center at Houston | Houston, Texas, United States | Not Yet Recruiting |
| University of Washington Harborview Medical Center | Seattle, Washington, United States | Recruiting |
+ 1 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05699174