Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 84 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. 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
  2. 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.
  3. Patients diagnosed with a wound infection of the study injury, defined as patients with at least one of the following:
  4. Deep culture positive after operative debridement.
  5. Cultures positive in thio only after operative debridement.
  6. Negative culture after operative debridement if wound infection meets the Center for Disease control and Prevention (CDC) criteria.
  7. Patients who are English or Spanish competent.
  8. Patients aged 18 - 84.
  9. Patients with bacteria susceptible to both PO and IV antibiotics.
  10. Patients able to be treated for their infection at the METRC facility for at least 12 months following definitive surgical procedure
  11. Patients may have multiple eligible study-eligible injuries.
  12. Patients may have temporary external fixation prior to definitive fixation.
  13. Patients may have received antibiotics prior to operative wound debridement.
  14. Patient is able to obtain study medication(s).
  15. Patient may be pregnant at the time of screening.

Exclusion Criteria

  1. Patients who have high risk of amputation of the study limb (based on opinion of the initial managing physician).
  2. Patients undergoing treatment with any other investigational therapy within the month preceding implantation or planned within the 12 months following implantation.
  3. 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.

4. Patients with pathological fractures; a known history of Paget's disease.

5. Patients for whom the definitive treatment of the study injury was an external fixator.

6. Patients who are currently on Selective Serotonin Reuptake Inhibitor (SSRI) medication (e.g. Zoloft, Prozac, Celexa), and bacteria is MRSA

7. Patients with cultures positive in thio only.

8. 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. .

9. Patients or designated proxy who are unwilling to provide consent.

10. Patients with a history of IV drug use who in the investigator's opinion are unsuitable candidates for IV therapy.

11. 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.

12. Patients with traumatic brain injury or who are intellectually challenged and who lack adequate family support to ensure adherence to the protocol.

13. Patients unable to swallow oral medications or without adequately functioning GI tract.

14. 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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Oral Antibiotic
Oral Antibiotic Arm; Participants assigned to this group will receive oral antibiotics as prescribed by their treating physician.
  • Other: PO versus IV antibiotics Route of administration evaluation
    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.
    Other names:
    • based on local practices and bacterial susceptibilities
Active Comparator
IV Antibiotic
Participants assigned to this group will receive intravenous (IV) antibiotics as prescribed by their treating physician.
  • Other: PO versus IV antibiotics Route of administration evaluation
    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.
    Other names:
    • based on local practices and bacterial susceptibilities

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Karen Trochez
karen.m.trochez@Vanderbilt.Edu

More Details

NCT ID
NCT01714596
Status
Recruiting
Sponsor
Major Extremity Trauma Research Consortium

Study Contact

Craig Remenapp, MS
410-614-3576
cremena1@jhu.edu

Detailed Description

Not provided here. Details listed above.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.