A Prospective Randomized Trial to Assess PO versus IV Antibiotics for the Treatment of Post-op Wound Infection after Extremity Fractures (POvIV Study)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Infection Following A Procedure, Not Elsewhere Classified
  • Age: Between 18 - 84 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects 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
    2. Subjects 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
    3. Subjects 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 CDC criteria
    4. Subjects who are English or Spanish competent.
    5. Subjects who are between the ages of 18 and 84 years old
    6. Subjects who are bacteria susceptible to both PO and IV antibiotics
    7. Subjects able to be treated for their infection at the METRC facility for at least 12 months following definitive surgical procedure
    8. Subjects may have multiple eligible study-eligible injuries
    9. Subjects may have temporary external fixation prior to definitive fixation
    10. Subjects may have received antibiotics prior to operative wound debridement.
    11. Subjects who are able to obtain study medication(s)
    12. Subjects who are not pregnant

You may not be eligible for this study if the following are true:

    1. Subjects who have high risk of amputation of the study limb
    2. Subjects undergoing treatment with any other investigational therapy within the month preceding implantation or planned within the 12 months following implantation
    3. Subjects 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 two or more instances of surgical treatment of infection AND approximately 6 week course of antibiotics.
    4. Subjects with pathological fractures; a known history of Paget’s disease
    5. Subjects for whom the definitive treatment of the study injury was an external fixator.
    6. Subjects who are currently on Selective Serotonin Reuptake Inhibitor (SSRI) medication (e.g. Zoloft, Prozac, Celexa), and bacteria is MRSA
    7. Subjects 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.
    8. Subjects who are unwilling to provide consent
    9. Subjects with a history of IV drug use who in the investigator’s opinion are unsuitable candidates for IV therapy.
    10. Subjects 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
    11. Subjects with traumatic brain injury or who are intellectually challenged and who lack adequate family support to ensure adherence to the protocol
    12. Subjects unable to swallow oral medications or without adequately functioning GI tract
    13. Subjects who, based upon the clinical judgment of the treating clinician, are NOT equally suited for treatment with either oral or intravenous antibiotics

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