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

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ClinicalTrials.gov Identifier: NCT02227446
Recruitment Status : Recruiting
First Posted : August 28, 2014
Last Update Posted : December 23, 2016
Sponsor:
Information provided by (Responsible Party):
Major Extremity Trauma Research Consortium

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 Vancomycin powder compared to those treated without local Vancomycin powder at the time of fracture fixation.

Condition or disease Intervention/treatment Phase
Post Operative Surgical Site Infection Drug: Vancomycin antibiotic powder Phase 3

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.

Primary Hypothesis: The proportion of deep surgical site infections will be lower for patients treated with local Vancomycin powder.

Secondary Aim #1: Compare antibiotic sensitivities of the bacteria in the patients who develop deep surgical site infections in study patients treated with local Vancomycin powder compared to those treated without local Vancomycin powder.

Hypothesis 1: In the patients who develop infections, the antibiotic sensitivity profiles between patients treated with local Vancomycin powder will be non-inferior to those treated without local Vancomycin powder.

Secondary Aim #2: Build and validate a risk prediction model for the development of deep surgical site infections in patients treated without local Vancomycin powder. (b) Explore whether the effect of local Vancomycin powder is modified by the predicted risk of infection.

Hypothesis 2: Patient (e.g. medical co-morbidities) and injury (e.g open fractures) factors will be highly predictive of infection risk.

Hypothesis 3: Patients with higher predictive risk will experience greater benefit from local antibiotics.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Local Antibiotic Therapy to Reduce Infection After Operative Treatment of Fractures at High Risk of Infection: A Multicenter Randomized, Controlled Trial (Vancomycin Study)
Study Start Date : October 2014
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vancomycin Antibotic Powder

Participants in the treatment group will receive the study intervention of a maximum dose of 1000mg of Vancomycin antibiotic powder in their wound bed, which is placed right before wound closure. Vancomycin antibiotic powder may be combined with normal saline as per clinical practice at the participating institution.

In addition, participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection.

Drug: Vancomycin antibiotic powder
At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure.

No Intervention: Standard of Care
Participants in this group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection. Participants in this group will not receive local Vancomycin antibiotic powder.



Primary Outcome Measures :
  1. Surgical Site Infection [ Time Frame: 24 weeks ]

    The main outcome will be the presence of clinically significant surgical site infection (SSI) in the first 26 weeks after surgery, as determined by CDC guidelines. The CDC criteria is currently 3 months for surgical site infection. To help capture more infections the study investigators have moved the time frame back to 6 months.

    Wound characteristics will also be evaluated using the ASEPSIS score. In this system wounds are scored using the weighted sum of points assigned for predetermined criteria including the need for Additional treatment, presence of Serous drainage, Erythema, Purulent exudates, Separation of deep tissues, the Isolation of bacteria, and the duration of patients Stay (ASEPSIS).

    The study investigators will define deep infections as those that require operative treatment, and superficial infections as those that are treated without operative intervention.



Secondary Outcome Measures :
  1. Bacterial Antibiotic Resistance Rate of Infected Participants [ Time Frame: 26 weeks ]

    Secondary outcome measures in this study include culture data in the group that becomes infected. Sensitivities of the isolate determined routinely in current clinical practice, will be recorded for analysis.

    The most common bacterial isolates in infection after orthopaedic fracture care are methicillin resistant staph. aureus and methicillin resistant coagulase negative Staphylococci. The rate of bacterial Vancomycin sensitivity will be measured and analyzed.


  2. Identify Risk Factors for Infection [ Time Frame: 26 weeks ]

    A secondary outcome measure will be to determine the risk for postoperative infection as well as determine which patients are most likely to benefit from the local Vancomycin powder technique.

    Demographic variables will include age, presence of co-morbidities such as diabetes, smoking history, history of prior musculoskeletal infection, and history of infection within the past 30 days.

    Injury descriptors will include injury mechanism, open or closed fracture type, AO classification of the fracture type, other orthopaedic injuries, and other non-orthopaedic injuries.

    Treatment parameters will include time from injury to definitive treatment, time from injury to external fixation, and surgical approaches used.




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227446


Contacts
Contact: Susan Collins, MSc 4105028966 scolli21@jhu.edu

Locations
United States, Maryland
University of Maryland R Adams Cowley Shock Trauma Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Yasmin Degani       ydegani@umoa.umm.edu   
Principal Investigator: Robert O'Toole, MD         
Sponsors and Collaborators
Major Extremity Trauma Research Consortium
Investigators
Principal Investigator: Renan Castillo, PhD Johns Hopkins Bloomberg School of Public Health
Principal Investigator: Robert O'Toole, MD University of Maryland R Adams Cowley Shock Trauma Center
Study Director: Anthony Carlini, MS Johns Hopkins Bloomberg School of Public Health

Additional Information:
Responsible Party: Major Extremity Trauma Research Consortium
ClinicalTrials.gov Identifier: NCT02227446     History of Changes
Other Study ID Numbers: W81XWH-10-2-0134
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: December 23, 2016
Last Verified: December 2016

Keywords provided by Major Extremity Trauma Research Consortium:
Surgical site infection risk prevention
Bacterial species type and antibacterial sensitives

Additional relevant MeSH terms:
Infection
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Vancomycin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents