Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (VANCO)
Condition: Post Operative Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection
Intervention: Vancomycin antibiotic powder
Intervention description: At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure.
Intervention MeSH terms: Anti-Bacterial Agents; Vancomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1036.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Surgical site infection risk prevention; Bacterial species type and antibacterial sensitives

Summary:

      The Vancomycin Study is a multi-center, prospective randomized controlled trial that will
      compare the proportion of deep surgical site infections within 6 months in patients treated
      with local Vancomycin powder compared to those treated without local Vancomycin powder at the
      time of fracture fixation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All "high energy" tibial plateau fractures treated operatively with plate and screw
             fixation.

          -  We define "high energy" tibial plateau fractures as patients who are either:

               -  Initially treated with an external fixation (with or without limited internal
                  fixation) and treated definitively more than 3 days later after swelling has
                  resolved.

               -  Any open type I, II, or IIIA fracture, regardless of timing of definitive
                  treatment.

               -  Any tibial plateau fracture associated with ipsilateral leg compartment syndrome
                  fasciotomy wounds.

          -  All "high energy" pilon (distal tibial plafond) fractures treated operatively with
             plate and screw fixation. We define "high energy" pilon fractures as patients who are
             either:

               -  Initially treated with an external fixation (with or without fibula fixation or
                  limited internal fixation) and treated definitively more than 3 days later after
                  swelling has resolved.

               -  Any open type I, II, or IIIA fracture, regardless of timing of definitive
                  treatment.

               -  Any tibial pilon fracture associated with ipsilateral leg compartment syndrome
                  fasciotomy wounds.

          -  Ages 18 to 80 years

          -  Patients may have co-existing non-tibial infection, with or without antibiotic
             treatment.

          -  Patients may have risk factors for infection including diabetes, immunosuppression
             from steroids or other medications, HIV, or other infections.

          -  Patients may have a head injury

          -  Patients may have a portion of the fixation (e.g. fibula fixation in pilon or
             percutaneous screws across a tibial plateau fracture) prior to definitive plate
             fixation, at the initial surgery before randomization.

          -  Patients may have other orthopedic and non-orthopaedic injuries.

          -  Patients may have pre-existing musculoskeletal injuries, be non ambulators, or have
             spinal cord injuries.

          -  Women and minorities are included

        Exclusion Criteria:

          -  The study injury: tibial plateau, pilon, is already infected at time of study
             enrollment.

          -  Patient speaks neither English nor Spanish.

          -  Patients who have already had definitive fixation prior to enrollment in the study.

          -  Severe problems with maintaining follow-up (e.g. patients who are homeless at the time
             of injury or those how are intellectually challenged without adequate family support).

          -  Patients with allergies, drug administration reactions, or other sensitivities to
             Vancomycin (such as a history of Redman's Syndrome).

          -  Pregnancy.

          -  The study injury is a type IIIB or IIIC open fracture.