Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (VANCO)

• Status: Completed
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Major Extremity Trauma Research Consortium
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Vancomycin

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.