Randomized Trial to Assess PO Versus IV Antibiotics
a study on Wound Infection
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: 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.
A Prospective Randomized Trial to Assess PO Versus IV Antibiotics for the Treatment of Post-op Wound Infection After Extremity Fractures (POvIV)
Not provided here. Details listed above.
Wound Infection Oral Antibiotic Intravenous Antibiotic Randomized Controlled Trial Infection Anti-Bacterial Agents Antibiotics, Antitubercular PO versus IV antibiotics Route of administration evaluation IV Antibiotic
You can join if…
Open to people ages 18-84
- 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.
You CAN'T join if...
- Patients who have high risk of amputation of the study limb (based on opinion of the initial managing physician).
- Patients undergoing treatment with any other investigational therapy within the month preceding implantation or planned within the 12 months following implantation.
- Patients with history of chronic infection at the site of study injury, defined as:
patients with chronic osteomyelitis identified by radiographic erosion or sequestrum; or patients with more than one instance of surgical treatment of infection and approximately 6 week course of antibiotics.
- Patients with pathological fractures; a known history of Paget's disease.
- Patients for whom the definitive treatment of the study injury was an external fixator.
- Patients who are currently on Selective Serotonin Reuptake Inhibitor (SSRI) medication (e.g. Zoloft, Prozac, Celexa), and bacteria is MRSA
- Patients with cultures positive in thio only.
- Patients who are incarcerated or who have unstable housing situations due to concerns regarding ability to receive home care, adherence phone calls, and maintain follow up. .
- Patients or designated proxy who are unwilling to provide consent.
- . Patients with a history of IV drug use who in the investigator's opinion are unsuitable candidates for IV therapy.
- . Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area.
- . Patients with traumatic brain injury or who are intellectually challenged and who lack adequate family support to ensure adherence to the protocol.
- . Patients unable to swallow oral medications or without adequately functioning GI tract.
- . Patients who, based upon the clinical judgment of the treating clinician, are NOT equally suited for treatment with either oral or intravenous antibiotics (i.e., those for whom there is a clinical treatment preference).
- University of California at San Francisco
accepting new patients
San Francisco California United States
- Cedars Sinai Medical Center
accepting new patients
Los Angeles California United States
Lead Scientist at UCSF
- accepting new patients
- Start Date
- Completion Date
- Major Extremity Trauma Research Consortium
- Study Type
- Last Updated
Please contact me about this study
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT01714596.