Status:
COMPLETED
Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (VANCO)
Lead Sponsor:
Major Extremity Trauma Research Consortium
Conditions:
Post Operative Surgical Site Infection
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 Vancomy...
Detailed Description
Primary Aim: 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. Primar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
1036 Patients enrolled
Trial Details
Trial ID
NCT02227446
Start Date
October 1 2014
End Date
November 1 2019
Last Update
June 1 2021
Active Locations (1)
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1
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States, 21201