Sponsored by Major Extremity Trauma Research Consortium

Phase	Quota	Distance
Phase N/A		Near

The goal of this study is to evaluate the effect of treatment of early post-op wound infection in long bones treated with plate fixation 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.

Study Start Date: September 2012

Estimated Completion Date: December 2016

Specialties: Infectious Disease: Antimicrobials,Bone/Joint Orthopedics: Clinical Pharmacology,Surgical Technique,Trauma Physician Assistant: Clinical Pharmacology,Infectious Disease,Orthopedics

Interventions

• Other: PO versus IV antibiotics Route of administration evaluation

Inclusion criteria

• Patients with long bone fractures (defined as femurs, tibias, and fibulas of the legs, and the humeri, radii, and ulnas of the arms) treated with a plate that will be retained until union.
• Patients diagnosed with a wound infection of the study injury, defined as deep culture positive after operative debridement, within six weeks of definitive fixation.
• 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 a segmental defect of fracture up to 1 cm.
• Patients may have temporary external fixation prior to definitive fixation.
• Patients may have received antibiotics prior to open wound debridement.
• Patient is able to obtain study medication(s).
• Patient may be pregnant at the time of screening.

Exclusion criteria

• Patients who are skeletally immature (defined as less than 18 years of age or no radiographic evidence of epiphyseal closure).
• 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 prior history of infection at the site of study injury.
• Patients with segmental defects greater than 1 cm in length at the site of study injury.
• 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), except those with gram negative bacteria.
• Patients whose study injury was definitively closed with cement containing antibiotics. (Beads may be placed at initial debridement but must be removed prior to definitive wound or flap closure).
• 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).

Study Locations And Contact Information

• Vanderbilt University Medical Center, Nashville Tennessee
  
• Vanderbilt University Medical Center, Nashville Tennessee