A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for the Treatment of Post-op Wound Infection After Extremity Fractures (POvIV)
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.
• Patients with any fractures of any bone at or proximal to and including the tarsal/metatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding the spine, treated with any type of internal fixation, or
• Patients undergoing fusion of any bone at or proximal to and including the subtalar joint or radial carpal joint, (excluding the spine) that develop a post op wound infection at any time.
• Patients diagnosed with a wound infection of the study injury, defined as patients with at least one of the following:
∙ Deep culture positive after operative debridement.
‣ Cultures positive in thio only after operative debridement.
‣ Negative culture after operative debridement if wound infection meets the Center for Disease control and Prevention (CDC) criteria.
• Patients who are English or Spanish competent.
• Patients aged 18 - 84.
• Patients with bacteria susceptible to both PO and IV antibiotics.
• Patients able to be treated for their infection at the METRC facility for at least 12 months following definitive surgical procedure
• Patients may have multiple eligible study-eligible injuries.
• Patients may have temporary external fixation prior to definitive fixation.
⁃ Patients may have received antibiotics prior to operative wound debridement.
⁃ Patient is able to obtain study medication(s).
⁃ Patient may be pregnant at the time of screening.