SLR - June 2017 - JennaLou Hollnagel

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

Reference: O'Toole RV, Joshi M, Carlini AR, Murray CK, Allen LE, Scharfstein DO, Gary JL, Bosse MJ, Castillo RC. Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter, Randomized, Controlled Trial (VANCO STUDY). J Orthop Trauma. 2017 April, 31 Suppl 1:S18–S24.

Scientific Literature Review

Reviewed By: JennaLou Hollnagel, DPM

Residency Program: Bethesda Health, Boynton Beach and Florida

Podiatric Relevance: Surgical site infections (SSIs) are a common postoperative complication faced in many orthopaedic surgeries. There are multiple steps and protocols to help prevent surgical site infections, including intravenous antibiotics, practicing aseptic technique and copious irrigation. Although intravenous antibiotics are shown to be efficacious, they are delivered to areas in the body where they are not needed. Consequently, the concentration of the antibiotic to be delivered to the surgical site is limited. In addition, intravenous antibiotics can only be delivered to tissues with sufficient blood supply, which is often compromised in acutely injured tissues. These limiting factors often increase the risk for SSIs to occur. There are numerous clinical studies in spine literature that describe the use of local vancomycin powder to reduce SSIs.

Methods: This phase III, prospective, randomized, clinical trial assesses the efficacy of locally administered vancomycin powder to help prevent SSIs after definitive fixation of high-risk, lower-extremity fractures. While applying powder over an implant is considered to be “off label,” the study obtained an investigational new drug approval from the U.S. Food and Drug Administration. The study consists of approximately 500 patients between the ages of 18 and 80 years old, with a tibial plateau or plafond fractures at high risk of infection that were definitively treated with plate and screw fixation. During the study, there were two groups, the control (Standard of Care) and VANCO group. Both groups received prophylactic IV antibiotics. During definitive plate fixation, the VANCO group received 1,000 mg of sterile vancomycin powder over all metal implants at the time of wound closure versus no powder for the control. Clinical evaluation was obtained at the two-week, three-month and six-month follow-up visit.

Results: The study is ongoing and looking at two outcomes; the presence of deep SSI the first six months after surgery and bacterial speciation and sensitivities. The guidelines for both outcomes complement the U.S. Centers for Disease Control and Prevention guidelines, which provide clear criteria on evaluating surgical wounds and determining the presence or absence of infection.

Conclusions: The evidence will help conclude whether administering vancomycin powder in extremity trauma will decrease the amount of SSIs. The advantages to using vancomycin powder is the low cost (<$10/dose), ease of use and ready availability. If the results are positive, this will aid in reducing the incidence of infections postoperatively by introducing a minor change in a surgeon's existing practice while being cost-effective, both intra and postoperatively. 

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