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
|Condition or disease||Intervention/treatment||Phase|
|Post Operative Surgical Site Infection||Drug: Vancomycin antibiotic powder||Phase 3|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02227446
|Contact: Susan Collins, MScfirstname.lastname@example.org|
|United States, Maryland|
|University of Maryland R Adams Cowley Shock Trauma Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Yasmin Degani email@example.com|
|Principal Investigator: Robert O'Toole, MD|
|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|