Local antibiotic therapy to reduce infection after operative treatment of fractures at high risk of infection: A multicenter, randomized, controlled trial (VANCO study)

METRC

Research output: Contribution to journalArticle

Abstract

A number of clinical studies in the spine literature suggest that the use of local vancomycin powder may substantially reduce surgical site infections (SSIs). These studies are primarily retrospective and observational and few focus on orthopaedic trauma patients. This study is a phase III, prospective, randomized, clinical trial to assess the efficacy of locally administered vancomycin powder in the prevention of SSI after fracture surgery. The primary goal of the VANCO Study is to compare the proportion of deep SSI 6 months after fracture fixation surgery. A secondary objective is to compare species and antibacterial susceptibilities among study patients who develop SSI. An additional objective is to build and validate a risk prediction model for the development of SSI. The study population consists of patients aged 18-80 years with tibial plateau or pilon (tibial plafond) fractures, at higher risk of infection, and definitively treated with plate and screw fixation. Participants are block randomized (within center) in a 1:1 ratio to either treatment group (local vancomycin powder up to a maximum dose of 1000 mg, placed immediately before wound closure) or control group (standard of care) for each study injury location, and return to the clinic for evaluations at 2 weeks, 3 months, and 6 months after fixation. The targeted sample size for the study is 500 fractures per study arm. This study should provide important information regarding the use of local vancomycin powder during the definitive treatment of lower extremity fractures and has the potential to significantly reduce the incidence of infection after orthopaedic trauma.

Original languageEnglish (US)
Pages (from-to)S18-S24
JournalJournal of Orthopaedic Trauma
Volume31
DOIs
StatePublished - 2017

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Surgical Wound Infection
Vancomycin
Randomized Controlled Trials
Powders
Anti-Bacterial Agents
Infection
Wounds and Injuries
Orthopedics
Therapeutics
Fracture Fixation
Tibial Fractures
Standard of Care
Sample Size
Observational Studies
Lower Extremity
Spine
Arm
Retrospective Studies
Control Groups
Incidence

Keywords

  • Biofilm
  • Local antibiotics
  • Surgical site infection
  • Tibial pilon fractures
  • Tibial plateau fractures
  • Vancomycin powder

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

Cite this

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title = "Local antibiotic therapy to reduce infection after operative treatment of fractures at high risk of infection: A multicenter, randomized, controlled trial (VANCO study)",
abstract = "A number of clinical studies in the spine literature suggest that the use of local vancomycin powder may substantially reduce surgical site infections (SSIs). These studies are primarily retrospective and observational and few focus on orthopaedic trauma patients. This study is a phase III, prospective, randomized, clinical trial to assess the efficacy of locally administered vancomycin powder in the prevention of SSI after fracture surgery. The primary goal of the VANCO Study is to compare the proportion of deep SSI 6 months after fracture fixation surgery. A secondary objective is to compare species and antibacterial susceptibilities among study patients who develop SSI. An additional objective is to build and validate a risk prediction model for the development of SSI. The study population consists of patients aged 18-80 years with tibial plateau or pilon (tibial plafond) fractures, at higher risk of infection, and definitively treated with plate and screw fixation. Participants are block randomized (within center) in a 1:1 ratio to either treatment group (local vancomycin powder up to a maximum dose of 1000 mg, placed immediately before wound closure) or control group (standard of care) for each study injury location, and return to the clinic for evaluations at 2 weeks, 3 months, and 6 months after fixation. The targeted sample size for the study is 500 fractures per study arm. This study should provide important information regarding the use of local vancomycin powder during the definitive treatment of lower extremity fractures and has the potential to significantly reduce the incidence of infection after orthopaedic trauma.",
keywords = "Biofilm, Local antibiotics, Surgical site infection, Tibial pilon fractures, Tibial plateau fractures, Vancomycin powder",
author = "METRC and O'Toole, {Robert V.} and Manjari Joshi and Carlini, {Anthony R} and Murray, {Clinton K.} and Allen, {Lauren Elizabeth} and Scharfstein, {Daniel O} and Gary, {Joshua L.} and Bosse, {Michael J.} and Castillo, {Renan Carlos} and Susan Collins and Yanjie Huang and Mackenzie, {Ellen J} and Tara Taylor and Mary Zadnik",
year = "2017",
doi = "10.1097/BOT.0000000000000801",
language = "English (US)",
volume = "31",
pages = "S18--S24",
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T1 - Local antibiotic therapy to reduce infection after operative treatment of fractures at high risk of infection

T2 - A multicenter, randomized, controlled trial (VANCO study)

AU - METRC

AU - O'Toole, Robert V.

AU - Joshi, Manjari

AU - Carlini, Anthony R

AU - Murray, Clinton K.

AU - Allen, Lauren Elizabeth

AU - Scharfstein, Daniel O

AU - Gary, Joshua L.

AU - Bosse, Michael J.

AU - Castillo, Renan Carlos

AU - Collins, Susan

AU - Huang, Yanjie

AU - Mackenzie, Ellen J

AU - Taylor, Tara

AU - Zadnik, Mary

PY - 2017

Y1 - 2017

N2 - A number of clinical studies in the spine literature suggest that the use of local vancomycin powder may substantially reduce surgical site infections (SSIs). These studies are primarily retrospective and observational and few focus on orthopaedic trauma patients. This study is a phase III, prospective, randomized, clinical trial to assess the efficacy of locally administered vancomycin powder in the prevention of SSI after fracture surgery. The primary goal of the VANCO Study is to compare the proportion of deep SSI 6 months after fracture fixation surgery. A secondary objective is to compare species and antibacterial susceptibilities among study patients who develop SSI. An additional objective is to build and validate a risk prediction model for the development of SSI. The study population consists of patients aged 18-80 years with tibial plateau or pilon (tibial plafond) fractures, at higher risk of infection, and definitively treated with plate and screw fixation. Participants are block randomized (within center) in a 1:1 ratio to either treatment group (local vancomycin powder up to a maximum dose of 1000 mg, placed immediately before wound closure) or control group (standard of care) for each study injury location, and return to the clinic for evaluations at 2 weeks, 3 months, and 6 months after fixation. The targeted sample size for the study is 500 fractures per study arm. This study should provide important information regarding the use of local vancomycin powder during the definitive treatment of lower extremity fractures and has the potential to significantly reduce the incidence of infection after orthopaedic trauma.

AB - A number of clinical studies in the spine literature suggest that the use of local vancomycin powder may substantially reduce surgical site infections (SSIs). These studies are primarily retrospective and observational and few focus on orthopaedic trauma patients. This study is a phase III, prospective, randomized, clinical trial to assess the efficacy of locally administered vancomycin powder in the prevention of SSI after fracture surgery. The primary goal of the VANCO Study is to compare the proportion of deep SSI 6 months after fracture fixation surgery. A secondary objective is to compare species and antibacterial susceptibilities among study patients who develop SSI. An additional objective is to build and validate a risk prediction model for the development of SSI. The study population consists of patients aged 18-80 years with tibial plateau or pilon (tibial plafond) fractures, at higher risk of infection, and definitively treated with plate and screw fixation. Participants are block randomized (within center) in a 1:1 ratio to either treatment group (local vancomycin powder up to a maximum dose of 1000 mg, placed immediately before wound closure) or control group (standard of care) for each study injury location, and return to the clinic for evaluations at 2 weeks, 3 months, and 6 months after fixation. The targeted sample size for the study is 500 fractures per study arm. This study should provide important information regarding the use of local vancomycin powder during the definitive treatment of lower extremity fractures and has the potential to significantly reduce the incidence of infection after orthopaedic trauma.

KW - Biofilm

KW - Local antibiotics

KW - Surgical site infection

KW - Tibial pilon fractures

KW - Tibial plateau fractures

KW - Vancomycin powder

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VL - 31

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JO - Journal of Orthopaedic Trauma

JF - Journal of Orthopaedic Trauma

SN - 0890-5339

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