The goal of this study is to evaluate the effect of treatment of post-op wound infection in long bones after fracture fixation or joint fusion and either: (Group 1) operative debridement and PO antibiotic treatment for 6 weeks; or (Group 2) operative debridement and IV antibiotics for 6 weeks. Primary Hypothesis 1: The rate of study injury related surgical interventions by one year in Group 1 will be non-inferior to the rate in Group 2. Secondary Hypothesis 1: The rate of treatment failure by one year in Group 1 will be non-inferior to the rate in Group 2. Treatment failure is defined as wound problems that require surgery \>2 weeks after initial debridement, infection recurrence, infection with a new pathogen, joint erosion, implant failure, medical problems related to the treatment administration which necessitates a switch from one arm to the other. Secondary Hypothesis 2: The rate of re-hospitalization for complications, infection, non-union and amputation by one year in Group 1 will be non-inferior to the rate in Group 2. Secondary Hypothesis 3: Following discharge for treatment of infection, per patient treatment costs at 1 year will be lower in Group 1 than in Group 2. Secondary Hypothesis 4: Adherence in Group 1 will be non-inferior to adherence in Group 2. Secondary Hypothesis 5: Patient satisfaction with treatment in Group 1 will be non-inferior to adherence in Group 2. Specific Aim 2: To build and validate a risk prediction model for failure of treatment of early post-op wound infections after fixation of fractures and joint fusions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
233
This is a study of oral (per os, (PO)) antibiotic therapy versus intravenous (IV) antibiotics in the treatment of acute infection after fixation of fractures and joint fusions. This is not a study of an experimental drug but a study of route of administration of standard use antibiotics. Antibiotic regimen options decision will be made by the Study Surgeon at each site in consult with local Infectious Disease experts based on local standard practices and bacterial susceptibilities.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California at San Francisco
San Francisco, California, United States
Denver Health and Hospital Authority
Denver, Colorado, United States
University of Miami Ryder Trauma Center
Miami, Florida, United States
Eskenazi Health
Indianapolis, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
...and 14 more locations
Study injury related surgical interventions by 1 year
Time frame: 1 year
Treatment Failure by 1 year
Treatment failure is defined as wound problems that require surgery \>2 weeks after initial debridement, infection recurrence, infection with a new pathogen, joint erosion, implant failure, medical problems related to the treatment administration which necessitates a switch from one arm to the other.
Time frame: 1 year
Re-hospitalizations by 1 year
Re-hospitalization for complications, such as infection, non-union and amputation
Time frame: 1 year
Healthcare costs
Cost of PO versus IV medications include medical record and bill abstracted costs associated with outpatient clinic visits, home health visits, medication, subsequent hospital readmission, and other types of medical care as identified over the course of the study.
Time frame: 1 year
Medication Adherence
Patient adherence to PO and IV medications Patient adherence with PO antibiotics will be monitored through wireless-enabled microchip monitors embedded in pill bottles by the Medication Event Monitoring System (MEMS) and weekly adherence questionnaire.
Time frame: 1 year
Satisfaction with treatment
Patient satisfaction with treatment measured by Short Form Patient Satisfaction Questionnaire (PSQ-18) The PSQ-18 measures 6 domains: technical quality, interpersonal manner, communication, financial aspects of care, time spent with doctor, and accessibility. A score of 0.8 or higher in each domain correlates with improved satisfaction.
Time frame: 1 year
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