<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04500275</url>
  </required_header>
  <id_info>
    <org_study_id>A-BR-109-013</org_study_id>
    <nct_id>NCT04500275</nct_id>
  </id_info>
  <brief_title>Topical Vancomycin Over Sternal Edge in Cardiac Surgery</brief_title>
  <official_title>Topical Vancomycin Paste Over Sternal Edge: Safety and Effect of on Incidence of Sternal Wound Infection After Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a single-blind 1:1 randomized controlled trial based on the hypothesis that topical&#xD;
      application of vancomycin paste over sternum edge is safe and can reduce sternal wound&#xD;
      infection after elective cardiac surgery. Vancomycin paste will be prepared using 2.5 g of&#xD;
      vancomycin mixed with 2 ml normal saline. Vancomycin paste as control or 2 ml normal saline&#xD;
      as placebo will be spread on sternal edge immediately after sternotomy and before sternal&#xD;
      closure. The safety of Vancomycin paste over sternum edge will be assessed according to&#xD;
      postoperative serum Vancomycin exposure and potential side effects such as renal toxicity or&#xD;
      bacterial resistance. Effect of topical Vancomycin on incidence of postoperative sternal&#xD;
      wound infection will be assessed on postoperative 7, 30, and 90 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Patient Recruitment and Group Assignment&#xD;
&#xD;
        1. Institution. All the surgical procedures will be undertaken in the National Cheng Kung&#xD;
           University Hospital (NCKUH) under service of the Cardiovascular Surgery Department. The&#xD;
           patient monitoring will be carried out perioperatively in the general ward and intensive&#xD;
           surgical unit (ICU, surgical or cardiac) of National Cheng Kung University Hospital.&#xD;
&#xD;
        2. Eligibility Criteria. Described in other section.&#xD;
&#xD;
        3. Randomization. Eligible patients will be 1:1 randomized using a computer-generated list&#xD;
           to receive either normal saline (Control group) or Vancomycin Paste (Vancomycin group).&#xD;
           A randomization list with corresponding patient recruitment number will be archived in&#xD;
           NCKUH pharmacy. On the operating day, our research coordinator will order a study&#xD;
           prescription, which looks identical to either control or Vancomycin group. The pharmacy&#xD;
           will deliver the prescription content according to the patient recruitment number on the&#xD;
           randomization list. The surgeons will know the patient grouping only after they get the&#xD;
           prescription content in the operating room.&#xD;
&#xD;
        4. Blinding. The intraoperative staff including the surgeon will know the application&#xD;
           material for the patients. The patient and the nursing staff in charge of sternal wound&#xD;
           evaluation will not know the allocation of patients.&#xD;
&#xD;
        5. Sample Size Determination. The average incidence of DSWI after isolated CABG in NCKUH is&#xD;
           3-4% in recent 5 years. An expected reduction of DSWI from 4% to 1% leads to an effect&#xD;
           size of 0.15, which will require a total sample size of 330 to achieve a statistical&#xD;
           power of 0.8 given an alpha error probability of 0.05 and 1 degree of freedom.&#xD;
           (Estimation with G*Power software). Considering the potential patient withdrawals, our&#xD;
           planned sample collection will be 360 cases (180 in each group) in two years.&#xD;
&#xD;
           ----------------------------------------------------------------------------------------&#xD;
           ---------------&#xD;
&#xD;
      2. Intervention&#xD;
&#xD;
      (1) Vancomycin group protocol. i. Timing of application: the Vancomycin® (China Chemical &amp;&#xD;
      Pharmaceutical Co., Ltd. (CCPC / Taiwab) paste will be spread on sternal edge immediately&#xD;
      after sternotomy and before sternal closure.&#xD;
&#xD;
      ii. Regimen: The vancomycin paste will be prepared using 2.5g of vancomycin mixed with 2ml&#xD;
      normal saline for each time. A total of 5gm of vancomycin® powder will be applied.&#xD;
&#xD;
      (2) Control group protocol. 2ml normal saline will be spread on sternal edge immediately&#xD;
      after sternotomy and before sternal closure.&#xD;
&#xD;
      (3) Common perioperative protocols in both groups regarding sternal wound infection&#xD;
      prevention: i. Intravenous antibiotics: Cefazolin 1g q8h for 24hrs. Patients with known&#xD;
      cephalosporin or beta-lactam allergy will receive single dose Vancomycin plus Gentamicin.&#xD;
&#xD;
      ii. Skin preparation: Skin shave will be performed on the operation day after injection of&#xD;
      prophylactic antibiotics. Skin sterilization will be prepared with alcohol beta-iodine scrub&#xD;
      followed by Hibitane (Chlorhexidine Gluconate).&#xD;
&#xD;
      iii. Bone wax: bone wax usage for hemostasis will be minimized and be removed as much as&#xD;
      possible before sternal closure.&#xD;
&#xD;
      iv. Internal mammary artery harvest: Bilateral internal mammary arteries will be used at the&#xD;
      discretion of the individual surgeon.&#xD;
&#xD;
      v. Sternum closure: our standard is 8 single wires closure. Replacement of any 2 single wires&#xD;
      with a figure of eight wire or addition of Robicsek technique will depend on the decision of&#xD;
      the individual surgeon.&#xD;
&#xD;
      vi. Subcutaneous and skin closure: interrupted Vircyl for subcutaneous closure and staples&#xD;
      for skin.&#xD;
&#xD;
      vii. Blood glucose control: intravenous insulin infusions to maintain serum blood glucose&#xD;
      level between 120 and 180 mg/dL.&#xD;
&#xD;
      viii. Chest hugger: postoperative chest hugger will be used according to the preference of&#xD;
      the individual patient.&#xD;
&#xD;
      ix. Delayed sternal closure: The decision is based on the discretion of the individual&#xD;
      surgeon. If a delayed closure is attempted, the vancomycin paste will still be applied over&#xD;
      the unclosed sternal edge.&#xD;
&#xD;
      ---------------------------------------------------------------------------------------------&#xD;
      ----------&#xD;
&#xD;
      3. Outcome Measurement. Details described in other section.&#xD;
&#xD;
      (1) Sternal wound. Measurement on postoperative day (POD) 7, 30, and 90, based on the&#xD;
      definition from Centers for Disease Control and Prevention.&#xD;
&#xD;
      (2) Serum Vancomycin levels. Sampling time: postoperative day 0, 3 and 7. Measurement: High&#xD;
      performance liquid chromatography (HPLC).&#xD;
&#xD;
      ---------------------------------------------------------------------------------------------&#xD;
      ----------&#xD;
&#xD;
      4. Data and Registry.&#xD;
&#xD;
        1. Data dictionary. Each variable in a row, presented in the following order: Variable,&#xD;
           Coding Information, Range (numeric data) or Levels (categorial data), Information Source&#xD;
           i. Sex, Sex, M or F, Electrical Medical Record&#xD;
&#xD;
           ii. Age, Age, 20 - 100, Electrical Medical Record&#xD;
&#xD;
           iii. Height, Body Height, 100 - 200, Electrical Medical Record&#xD;
&#xD;
           iv. Weight, Body Weight, 30 - 150, Electrical Medical Record&#xD;
&#xD;
           v. DM, Diabetes Mellitus, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           vi. DM control, Diabetes Mellitus control method, 0 or Oral or Insulin, Electrical&#xD;
           Medical Record&#xD;
&#xD;
           vii. HTN, Hypertension, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           viii. PAOD, Peripheral artery occlusion disease, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           ix. Dialysis, Dialysis, 0 or HD or PD, Electrical Medical Record&#xD;
&#xD;
           x. OldCVA, Old Cerebral Vascular Accident, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xi. CarotidStenosis, Carotid Artery Stenosis, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xii. LiverDisease, Liver Disease, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xiii. COPD, Chronic Obstructive Pulomnary Disease, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xiv. Alcohol, Alcohol consumption, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xv. Tobacco, Tobacco use, Never or Current or Former, Electrical Medical Record&#xD;
&#xD;
           xvi. NYHA, NYHA Functional Class, 1, 2, 3, 4, Electrical Medical Record&#xD;
&#xD;
           xvii. Afib, Atrial Fibrillation; paroxysmal, persistent, permanent, Electrical Medical&#xD;
           Record&#xD;
&#xD;
           xviii. LVEF, Left Ventricular Ejection Fraction on preoperative echocardiography(%); 1 -&#xD;
           100, Electrical Medical Record&#xD;
&#xD;
           xix. Procedure, Surgical Procedure, &quot;AVR MVR DVR CABG Aorta others&quot;, Electrical Medical&#xD;
           Record&#xD;
&#xD;
           xx. XCtime, Cross-Clamp time (mins), 0 - 1000, Electrical Medical Record&#xD;
&#xD;
           xxi. CPBtime, Cardiopulmonary bypass time (mins), 0 - 1000, Electrical Medical Record&#xD;
&#xD;
           xxii. delay.closure, delayed sternal closure, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xxiii. SIMA, Single internal mammary artery graft, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xxiv. BIMA, Bilateral internal mammary artery graft, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xxv. BUN, Blood Urea Nitrogen , 0 - 100, Hospital Lab&#xD;
&#xD;
           xxvi. Cr, Serum Creatinine , 0 - 20, Hospital Lab&#xD;
&#xD;
           xxvii.AST, Serum Aspartate Aminotransferase level , 0 - 1000, Hospital Lab&#xD;
&#xD;
           xxviii.ALT, Serum Alanine Aminotransferase level , 0 - 1000, Hospital Lab&#xD;
&#xD;
           xxix. WBC, White blood cell count , 0 - 10, Hospital Lab&#xD;
&#xD;
           xxx. Albumin, serumAlbumin , 0 - 10, Hospital Lab&#xD;
&#xD;
           xxxi. Prealbumin, Serum Prealbumin level , 0 - 50, Hospital Lab&#xD;
&#xD;
           xxxii.TRF, Serum Transferrin level , 0 - 200, Hospital Lab&#xD;
&#xD;
           xxxiii.Serum Zinc level, Serum Zinc level , 70-120, Hospital Lab&#xD;
&#xD;
           xxxiv.TG, serum triglycerol level , 0 - 1000, Hospital Lab&#xD;
&#xD;
           xxxv.CHOL, serum CHOL level, 0 - 1000, Hospital Lab&#xD;
&#xD;
           xxxvi.HDL, serum high density lipoprotein level , 0 - 100, Hospital Lab&#xD;
&#xD;
           xxxvii.LDL, serum low density lipoprotein level , 0 - 1000, Hospital Lab&#xD;
&#xD;
           xxxviii.HbA1c, hemoglobin A1c level , 0 - 100, Hospital Lab&#xD;
&#xD;
           xxxix.Vanco.POD0, Serum Vancomycin level on postoperative day 0, 0 - 50, Study lab&#xD;
&#xD;
           xl. Vanco.POD3, Serum Vancomycin level on postoperative day 3, 0 - 50, Study lab&#xD;
&#xD;
           xli. Vanco.POD7, Serum Vancomycin level on postoperative day 7, 0 - 50, Study lab&#xD;
&#xD;
           xlii. Stroke, postoperative Stroke, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xliii. Bacteremia, postoperative Bacteremia, 0 or the bacteria species, Electrical&#xD;
           Medical Record&#xD;
&#xD;
           xliv. Pneumonia, postoperative Pneumonia, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xlv. Resistance.pathogen, Resistance pathogen, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           xlvi. Intubation.days, Intubation days, 0 - 100, Electrical Medical Record&#xD;
&#xD;
           xlvii. Mechanical.support.type, postoperative Mechanical support type, &quot;IABP ECMO VAD&quot;,&#xD;
           Electrical Medical Record&#xD;
&#xD;
           xlviii. Parenteral.nutrition, postoperative Parenteral nutrition, 0 or PPN or TPN,&#xD;
           Electrical Medical Record&#xD;
&#xD;
           xlix. ICU.days, ICU days, 1-100, Electrical Medical Record&#xD;
&#xD;
           l. Hospital.days, Hospital days, 1-100, Electrical Medical Record&#xD;
&#xD;
           li. ThirtyDays.mortality, 30 days mortality, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           lii. Hospital.mortality, Hospital mortality, 1 or 0, Electrical Medical Record&#xD;
&#xD;
           liii. Wound.POD7, Sternal wound condition on postoperative day 7, normal or superficial&#xD;
           sternal infection or deep sternal infection, Study Nursing Practitioner&#xD;
&#xD;
           liv. Wound.POD30, Sternal wound condition on postoperative day 30, normal or superficial&#xD;
           sternal infection or deep sternal infection, Study Nursing Practitioner&#xD;
&#xD;
           lv. Wound.POD90, Sternal wound condition on postoperative day 90, normal or superficial&#xD;
           sternal infection or deep sternal infection, Study Nursing Practitioner&#xD;
&#xD;
        2. Data Collection:&#xD;
&#xD;
           i. Clinical parameters collection. All patient demographic data and parameters of STS&#xD;
           (society of thoracic surgery) database will be recorded, such as age, sex, cause of&#xD;
           cardiac diseases, co-morbidities, concurrent medication, body mass index, nutrition&#xD;
           status, operation details, days of hospital and ICU stay, hospital cost, any surgical&#xD;
           complications, and any documented infection and their microbiology susceptibility test&#xD;
           results.&#xD;
&#xD;
           ii. Biochemistry and blood cell count. Data such as creatinine levels, fasting sugar&#xD;
           levels, HbA1C, liver enzymes, nutrition status, and white cell count will be measured on&#xD;
           postoperative day 0, 3, and 7 in the central laboratory of National Cheng Kung&#xD;
           University Hospital.&#xD;
&#xD;
        3. Data management. i. Two registrars are responsible for data registry. Data are stored in&#xD;
           spread sheet format.&#xD;
&#xD;
           ii. Missing Data. All data source are available in NCKUH's electrical medical record.&#xD;
           Any variable with missing data more than 3% will be dropped.&#xD;
&#xD;
        4. Report for adverse events. The investigators are responsible for adverse events&#xD;
           reporting to our institution review board (NCKUH IRB). The reporting procedure is&#xD;
           generally based on the form from the Council for International Organizations of Medical&#xD;
           Sciences (CIOMS). The definition and requirement for Serious Adverse Event (SAE),&#xD;
           Suspected Unexpected Serious Adverse Reaction (SUSAR), and Unanticipated Problems (UP),&#xD;
           are available at our IRB website:&#xD;
           http://nckuhirb.med.ncku.edu.tw/upload/download/file20191217230754.pdf.&#xD;
&#xD;
        5. Quality assurance. This is a single institution study. Quality assurance will be done by&#xD;
           monthly investigator meeting in our hospital, which including the following:&#xD;
&#xD;
           i. Data checks. Monthly data visualization report, either histogram for continuous&#xD;
           variable or bar chart for categorial variable, will be used for detection of any data&#xD;
           running out of range or having inconsistency with predefined rules.&#xD;
&#xD;
           ii. Source data verification. Accuracy and completeness of the registry data will be&#xD;
           double checked by the primary care nursing practitioners by comparison with the&#xD;
           electrical medical record system.&#xD;
&#xD;
           ----------------------------------------------------------------------------------------&#xD;
           ---------------&#xD;
&#xD;
      5. Data Analysis, Statistical and Pharmacokinetic Analysis&#xD;
&#xD;
        1. For clinical data, continuous variables are expressed are as means ± standard deviation&#xD;
           and analyzed with t-test. Categorical variables are presented as numbers (percentages)&#xD;
           and Pearson's χ 2 or Fisher's exact test was used where appropriate. Univariate and&#xD;
           multivariate logistic regression model and Cox model will be used to analyze risk&#xD;
           factors for sternal wound infection. Significance was set at P &lt; 0.05. Statistical&#xD;
           analysis was performed using R, version 3.2.5 (R Foundation for Statistical Computing,&#xD;
           Vienna, Austria.).&#xD;
&#xD;
        2. For serum Vancomycin levels, non-compartmental analysis will be conducted with WinNonlin&#xD;
           software (www.certara.com). The population pharmacokinetics will be analyzed with&#xD;
           nonlinear mixed-effects modeling using in NONMEN 7.3 (Icon Development Solutions,&#xD;
           Hanover, MD). Xpose (xpose.sourceforge.net), PsN (psn.sourceforge.net), and R, version&#xD;
           3.2.5 (R Foundation for Statistical Computing, Vienna, Austria.) were used for&#xD;
           postprocessing of NONMEM output.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sternal wound infection condition on postoperative day 7</measure>
    <time_frame>postoperative day 7</time_frame>
    <description>Sternal wound condition evaluate by study nursing practitioner, according to the definition of sternal wound infection based on the Centers for Disease Control and Prevention.&#xD;
Depths 1 and 2 limited to the subcuticular and subcutaneous layers with no involvement of the sternum are deﬁned as a superﬁcial sternal infection (SSI).&#xD;
Depths 3 and 4, which involved the sternal bone or wires and collections beneath the sternum, are defined as deep sternal infection (DSI).&#xD;
A wound was considered infected only if a positive culture was obtained.&#xD;
The sternal wound condition will be coded as &quot;non-infection&quot;, &quot;SSI&quot;, &quot;DSI&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sternal wound infection condition on postoperative day 30</measure>
    <time_frame>postoperative day 30</time_frame>
    <description>Sternal wound condition evaluate by study nursing practitioner, according to the definition of sternal wound infection based on the Centers for Disease Control and Prevention.&#xD;
Depths 1 and 2 limited to the subcuticular and subcutaneous layers with no involvement of the sternum are deﬁned as a superﬁcial sternal infection (SSI).&#xD;
Depths 3 and 4, which involved the sternal bone or wires and collections beneath the sternum, are defined as deep sternal infection (DSI).&#xD;
A wound was considered infected only if a positive culture was obtained.&#xD;
The sternal wound condition will be coded as &quot;non-infection&quot;, &quot;SSI&quot;, &quot;DSI&quot;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sternal wound infection condition on postoperative day 90</measure>
    <time_frame>postoperative day 90</time_frame>
    <description>Sternal wound condition evaluate by study nursing practitioner, according to the definition of sternal wound infection based on the Centers for Disease Control and Prevention.&#xD;
Depths 1 and 2 limited to the subcuticular and subcutaneous layers with no involvement of the sternum are deﬁned as a superﬁcial sternal infection (SSI).&#xD;
Depths 3 and 4, which involved the sternal bone or wires and collections beneath the sternum, are defined as deep sternal infection (DSI).&#xD;
A wound was considered infected only if a positive culture was obtained.&#xD;
The sternal wound condition will be coded as &quot;non-infection&quot;, &quot;SSI&quot;, &quot;DSI&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum Vancomycin exposure on postoperative day 0</measure>
    <time_frame>postoperative day 0</time_frame>
    <description>Serum Vancomycin concentration (mcg/mL) measured with HPLC (high performance liquid chromatography)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Vancomycin exposure on postoperative day 3</measure>
    <time_frame>postoperative day 3</time_frame>
    <description>Serum Vancomycin concentration (mcg/mL) measured with HPLC (high performance liquid chromatography)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum Vancomycin exposure on postoperative day 7</measure>
    <time_frame>postoperative day 7</time_frame>
    <description>Serum Vancomycin concentration (mcg/mL) measured with HPLC (high performance liquid chromatography)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">360</enrollment>
  <condition>Sternal Wound Infection</condition>
  <arm_group>
    <arm_group_label>Vancomycin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>i. Timing of application: the Vancomycin (China Chemical &amp; Pharmaceutical Co., Ltd., CCPC, Taiwan R.O.C.) paste will be spread on sternal edge immediately after sternotomy and before sternal closure.&#xD;
ii. Regimen: The Vancomycin paste will be prepared using 2.5 g of Vancomycin powder mixed with 2 ml normal saline for each time. A total of 5 g of Vancomycin powder will be applied during the cardiac surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>2 ml normal saline will be spread on sternal edge immediately after sternotomy and before sternal closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin Hydrochloride</intervention_name>
    <description>Vancomycin will be spread on sternal edge immediately after sternotomy and before sternal closure</description>
    <arm_group_label>Vancomycin group</arm_group_label>
    <other_name>vancomycin® (China Chemical &amp; Pharmaceutical Co., Ltd. (CCPC / Taiwan))</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Normal Saline</intervention_name>
    <description>2 ml normal saline will be spread on sternal edge immediately after sternotomy and before sternal closure</description>
    <arm_group_label>Placebo group</arm_group_label>
    <other_name>Isotonic Sodium chloride 0.9% 20ml/amp (Sintong Taiwan Biotech Company, Limited.)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients admitted for elective cardiac surgery via first-time full&#xD;
             sternotomy, such as coronary artery disease, valvular heart disease, adult congenital&#xD;
             heart disease, aortic aneurysm.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  redo sternotomy surgery&#xD;
&#xD;
          -  minimal invasive or non-full-sternotomy cardiac surgery&#xD;
&#xD;
          -  emergent surgery with preoperative shock or cardiopulmonary resuscitation&#xD;
&#xD;
          -  heart transplant or ventricular assist device surgery&#xD;
&#xD;
          -  patients who have any preoperative mechanical support including IABP, ECMO, or&#xD;
             ventricular assist device&#xD;
&#xD;
          -  evidence of Vancomycin allergy&#xD;
&#xD;
          -  preexisting infection requiring preoperative regular antibiotics&#xD;
&#xD;
          -  perioperative immunosuppressive requirement&#xD;
&#xD;
          -  Patients with known cephalosporin or beta-lactam allergy who requires Vancomycin plus&#xD;
             Gentamicin for intravenous prophylaxis will also be excluded because the intravenous&#xD;
             Vancomycin will affect the further measurement of serum Vancomycin level after topical&#xD;
             application&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MENG-TA TSAI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cheng Kung University Hospital, Tainan, Taiwan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>MENG-TA TSAI, MD</last_name>
    <phone>+886-2353535</phone>
    <phone_ext>2609</phone_ext>
    <email>dongsar@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <state>台南市</state>
        <zip>704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun-Neng Roan, PhD</last_name>
      <phone>+886-2353535</phone>
      <phone_ext>2609</phone_ext>
      <email>roanjunneng@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Lazar HL, Ketchedjian A, Haime M, Karlson K, Cabral H. Topical vancomycin in combination with perioperative antibiotics and tight glycemic control helps to eliminate sternal wound infections. J Thorac Cardiovasc Surg. 2014 Sep;148(3):1035-8; 1038-40. doi: 10.1016/j.jtcvs.2014.06.045. Epub 2014 Jul 2.</citation>
    <PMID>25129595</PMID>
  </reference>
  <reference>
    <citation>Lazar HL, Barlam T, Cabral H. The effect of topical vancomycin applied to sternotomy incisions on postoperative serum vancomycin levels. J Card Surg. 2011 Sep;26(5):461-5. doi: 10.1111/j.1540-8191.2011.01300.x.</citation>
    <PMID>21951032</PMID>
  </reference>
  <reference>
    <citation>Lander HL, Ejiofor JI, McGurk S, Tsuyoshi K, Shekar P, Body SC. Vancomycin Paste Does Not Reduce the Incidence of Deep Sternal Wound Infection After Cardiac Operations. Ann Thorac Surg. 2017 Feb;103(2):497-503. doi: 10.1016/j.athoracsur.2016.10.020. Epub 2016 Dec 24.</citation>
    <PMID>28027730</PMID>
  </reference>
  <reference>
    <citation>Vander Salm TJ, Okike ON, Pasque MK, Pezzella AT, Lew R, Traina V, Mathieu R. Reduction of sternal infection by application of topical vancomycin. J Thorac Cardiovasc Surg. 1989 Oct;98(4):618-22.</citation>
    <PMID>2796369</PMID>
  </reference>
  <reference>
    <citation>Lazar HL, Salm TV, Engelman R, Orgill D, Gordon S. Prevention and management of sternal wound infections. J Thorac Cardiovasc Surg. 2016 Oct;152(4):962-72. doi: 10.1016/j.jtcvs.2016.01.060. Epub 2016 Aug 8. No abstract available.</citation>
    <PMID>27555340</PMID>
  </reference>
  <reference>
    <citation>Hamman BL, Stout LY, Theologes TT, Sass DM, da Graca B, Filardo G. Relation between topical application of platelet-rich plasma and vancomycin and severe deep sternal wound infections after a first median sternotomy. Am J Cardiol. 2014 Apr 15;113(8):1415-9. doi: 10.1016/j.amjcard.2013.12.046. Epub 2014 Jan 31.</citation>
    <PMID>24576548</PMID>
  </reference>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>September 26, 2022</last_update_submitted>
  <last_update_submitted_qc>September 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Meng-Ta Tsai</investigator_full_name>
    <investigator_title>Assistant Professor, Division of Cardiovascular Surgery, Department of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04500275
org study id: A-BR-109-013
nct id: NCT04500275
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a single-blind 1:1 randomized controlled trial based on the hypothesis that topical
      application of vancomycin paste over sternum edge is safe and can reduce sternal wound
      infection after elective cardiac surgery. Vancomycin paste will be prepared using 2.5 g of
      vancomycin mixed with 2 ml normal saline. Vancomycin paste as control or 2 ml normal saline
      as placebo will be spread on sternal edge immediately after sternotomy and before sternal
      closure. The safety of Vancomycin paste over sternum edge will be assessed according to
      postoperative serum Vancomycin exposure and potential side effects such as renal toxicity or
      bacterial resistance. Effect of topical Vancomycin on incidence of postoperative sternal
      wound infection will be assessed on postoperative 7, 30, and 90 days.
1. Patient Recruitment and Group Assignment

        1. Institution. All the surgical procedures will be undertaken in the National Cheng Kung
           University Hospital (NCKUH) under service of the Cardiovascular Surgery Department. The
           patient monitoring will be carried out perioperatively in the general ward and intensive
           surgical unit (ICU, surgical or cardiac) of National Cheng Kung University Hospital.

        2. Eligibility Criteria. Described in other section.

        3. Randomization. Eligible patients will be 1:1 randomized using a computer-generated list
           to receive either normal saline (Control group) or Vancomycin Paste (Vancomycin group).
           A randomization list with corresponding patient recruitment number will be archived in
           NCKUH pharmacy. On the operating day, our research coordinator will order a study
           prescription, which looks identical to either control or Vancomycin group. The pharmacy
           will deliver the prescription content according to the patient recruitment number on the
           randomization list. The surgeons will know the patient grouping only after they get the
           prescription content in the operating room.

        4. Blinding. The intraoperative staff including the surgeon will know the application
           material for the patients. The patient and the nursing staff in charge of sternal wound
           evaluation will not know the allocation of patients.

        5. Sample Size Determination. The average incidence of DSWI after isolated CABG in NCKUH is
           3-4% in recent 5 years. An expected reduction of DSWI from 4% to 1% leads to an effect
           size of 0.15, which will require a total sample size of 330 to achieve a statistical
           power of 0.8 given an alpha error probability of 0.05 and 1 degree of freedom.
           (Estimation with G*Power software). Considering the potential patient withdrawals, our
           planned sample collection will be 360 cases (180 in each group) in two years.

           ----------------------------------------------------------------------------------------
           ---------------

      2. Intervention

      (1) Vancomycin group protocol. i. Timing of application: the Vancomycin® (China Chemical &
      Pharmaceutical Co., Ltd. (CCPC / Taiwab) paste will be spread on sternal edge immediately
      after sternotomy and before sternal closure.

      ii. Regimen: The vancomycin paste will be prepared using 2.5g of vancomycin mixed with 2ml
      normal saline for each time. A total of 5gm of vancomycin® powder will be applied.

      (2) Control group protocol. 2ml normal saline will be spread on sternal edge immediately
      after sternotomy and before sternal closure.

      (3) Common perioperative protocols in both groups regarding sternal wound infection
      prevention: i. Intravenous antibiotics: Cefazolin 1g q8h for 24hrs. Patients with known
      cephalosporin or beta-lactam allergy will receive single dose Vancomycin plus Gentamicin.

      ii. Skin preparation: Skin shave will be performed on the operation day after injection of
      prophylactic antibiotics. Skin sterilization will be prepared with alcohol beta-iodine scrub
      followed by Hibitane (Chlorhexidine Gluconate).

      iii. Bone wax: bone wax usage for hemostasis will be minimized and be removed as much as
      possible before sternal closure.

      iv. Internal mammary artery harvest: Bilateral internal mammary arteries will be used at the
      discretion of the individual surgeon.

      v. Sternum closure: our standard is 8 single wires closure. Replacement of any 2 single wires
      with a figure of eight wire or addition of Robicsek technique will depend on the decision of
      the individual surgeon.

      vi. Subcutaneous and skin closure: interrupted Vircyl for subcutaneous closure and staples
      for skin.

      vii. Blood glucose control: intravenous insulin infusions to maintain serum blood glucose
      level between 120 and 180 mg/dL.

      viii. Chest hugger: postoperative chest hugger will be used according to the preference of
      the individual patient.

      ix. Delayed sternal closure: The decision is based on the discretion of the individual
      surgeon. If a delayed closure is attempted, the vancomycin paste will still be applied over
      the unclosed sternal edge.

      ---------------------------------------------------------------------------------------------
      ----------

      3. Outcome Measurement. Details described in other section.

      (1) Sternal wound. Measurement on postoperative day (POD) 7, 30, and 90, based on the
      definition from Centers for Disease Control and Prevention.

      (2) Serum Vancomycin levels. Sampling time: postoperative day 0, 3 and 7. Measurement: High
      performance liquid chromatography (HPLC).

      ---------------------------------------------------------------------------------------------
      ----------

      4. Data and Registry.

        1. Data dictionary. Each variable in a row, presented in the following order: Variable,
           Coding Information, Range (numeric data) or Levels (categorial data), Information Source
           i. Sex, Sex, M or F, Electrical Medical Record

           ii. Age, Age, 20 - 100, Electrical Medical Record

           iii. Height, Body Height, 100 - 200, Electrical Medical Record

           iv. Weight, Body Weight, 30 - 150, Electrical Medical Record

           v. DM, Diabetes Mellitus, 1 or 0, Electrical Medical Record

           vi. DM control, Diabetes Mellitus control method, 0 or Oral or Insulin, Electrical
           Medical Record

           vii. HTN, Hypertension, 1 or 0, Electrical Medical Record

           viii. PAOD, Peripheral artery occlusion disease, 1 or 0, Electrical Medical Record

           ix. Dialysis, Dialysis, 0 or HD or PD, Electrical Medical Record

           x. OldCVA, Old Cerebral Vascular Accident, 1 or 0, Electrical Medical Record

           xi. CarotidStenosis, Carotid Artery Stenosis, 1 or 0, Electrical Medical Record

           xii. LiverDisease, Liver Disease, 1 or 0, Electrical Medical Record

           xiii. COPD, Chronic Obstructive Pulomnary Disease, 1 or 0, Electrical Medical Record

           xiv. Alcohol, Alcohol consumption, 1 or 0, Electrical Medical Record

           xv. Tobacco, Tobacco use, Never or Current or Former, Electrical Medical Record

           xvi. NYHA, NYHA Functional Class, 1, 2, 3, 4, Electrical Medical Record

           xvii. Afib, Atrial Fibrillation; paroxysmal, persistent, permanent, Electrical Medical
           Record

           xviii. LVEF, Left Ventricular Ejection Fraction on preoperative echocardiography(%); 1 -
           100, Electrical Medical Record

           xix. Procedure, Surgical Procedure, "AVR MVR DVR CABG Aorta others", Electrical Medical
           Record

           xx. XCtime, Cross-Clamp time (mins), 0 - 1000, Electrical Medical Record

           xxi. CPBtime, Cardiopulmonary bypass time (mins), 0 - 1000, Electrical Medical Record

           xxii. delay.closure, delayed sternal closure, 1 or 0, Electrical Medical Record

           xxiii. SIMA, Single internal mammary artery graft, 1 or 0, Electrical Medical Record

           xxiv. BIMA, Bilateral internal mammary artery graft, 1 or 0, Electrical Medical Record

           xxv. BUN, Blood Urea Nitrogen , 0 - 100, Hospital Lab

           xxvi. Cr, Serum Creatinine , 0 - 20, Hospital Lab

           xxvii.AST, Serum Aspartate Aminotransferase level , 0 - 1000, Hospital Lab

           xxviii.ALT, Serum Alanine Aminotransferase level , 0 - 1000, Hospital Lab

           xxix. WBC, White blood cell count , 0 - 10, Hospital Lab

           xxx. Albumin, serumAlbumin , 0 - 10, Hospital Lab

           xxxi. Prealbumin, Serum Prealbumin level , 0 - 50, Hospital Lab

           xxxii.TRF, Serum Transferrin level , 0 - 200, Hospital Lab

           xxxiii.Serum Zinc level, Serum Zinc level , 70-120, Hospital Lab

           xxxiv.TG, serum triglycerol level , 0 - 1000, Hospital Lab

           xxxv.CHOL, serum CHOL level, 0 - 1000, Hospital Lab

           xxxvi.HDL, serum high density lipoprotein level , 0 - 100, Hospital Lab

           xxxvii.LDL, serum low density lipoprotein level , 0 - 1000, Hospital Lab

           xxxviii.HbA1c, hemoglobin A1c level , 0 - 100, Hospital Lab

           xxxix.Vanco.POD0, Serum Vancomycin level on postoperative day 0, 0 - 50, Study lab

           xl. Vanco.POD3, Serum Vancomycin level on postoperative day 3, 0 - 50, Study lab

           xli. Vanco.POD7, Serum Vancomycin level on postoperative day 7, 0 - 50, Study lab

           xlii. Stroke, postoperative Stroke, 1 or 0, Electrical Medical Record

           xliii. Bacteremia, postoperative Bacteremia, 0 or the bacteria species, Electrical
           Medical Record

           xliv. Pneumonia, postoperative Pneumonia, 1 or 0, Electrical Medical Record

           xlv. Resistance.pathogen, Resistance pathogen, 1 or 0, Electrical Medical Record

           xlvi. Intubation.days, Intubation days, 0 - 100, Electrical Medical Record

           xlvii. Mechanical.support.type, postoperative Mechanical support type, "IABP ECMO VAD",
           Electrical Medical Record

           xlviii. Parenteral.nutrition, postoperative Parenteral nutrition, 0 or PPN or TPN,
           Electrical Medical Record

           xlix. ICU.days, ICU days, 1-100, Electrical Medical Record

           l. Hospital.days, Hospital days, 1-100, Electrical Medical Record

           li. ThirtyDays.mortality, 30 days mortality, 1 or 0, Electrical Medical Record

           lii. Hospital.mortality, Hospital mortality, 1 or 0, Electrical Medical Record

           liii. Wound.POD7, Sternal wound condition on postoperative day 7, normal or superficial
           sternal infection or deep sternal infection, Study Nursing Practitioner

           liv. Wound.POD30, Sternal wound condition on postoperative day 30, normal or superficial
           sternal infection or deep sternal infection, Study Nursing Practitioner

           lv. Wound.POD90, Sternal wound condition on postoperative day 90, normal or superficial
           sternal infection or deep sternal infection, Study Nursing Practitioner

        2. Data Collection:

           i. Clinical parameters collection. All patient demographic data and parameters of STS
           (society of thoracic surgery) database will be recorded, such as age, sex, cause of
           cardiac diseases, co-morbidities, concurrent medication, body mass index, nutrition
           status, operation details, days of hospital and ICU stay, hospital cost, any surgical
           complications, and any documented infection and their microbiology susceptibility test
           results.

           ii. Biochemistry and blood cell count. Data such as creatinine levels, fasting sugar
           levels, HbA1C, liver enzymes, nutrition status, and white cell count will be measured on
           postoperative day 0, 3, and 7 in the central laboratory of National Cheng Kung
           University Hospital.

        3. Data management. i. Two registrars are responsible for data registry. Data are stored in
           spread sheet format.

           ii. Missing Data. All data source are available in NCKUH's electrical medical record.
           Any variable with missing data more than 3% will be dropped.

        4. Report for adverse events. The investigators are responsible for adverse events
           reporting to our institution review board (NCKUH IRB). The reporting procedure is
           generally based on the form from the Council for International Organizations of Medical
           Sciences (CIOMS). The definition and requirement for Serious Adverse Event (SAE),
           Suspected Unexpected Serious Adverse Reaction (SUSAR), and Unanticipated Problems (UP),
           are available at our IRB website:
           http://nckuhirb.med.ncku.edu.tw/upload/download/file20191217230754.pdf.

        5. Quality assurance. This is a single institution study. Quality assurance will be done by
           monthly investigator meeting in our hospital, which including the following:

           i. Data checks. Monthly data visualization report, either histogram for continuous
           variable or bar chart for categorial variable, will be used for detection of any data
           running out of range or having inconsistency with predefined rules.

           ii. Source data verification. Accuracy and completeness of the registry data will be
           double checked by the primary care nursing practitioners by comparison with the
           electrical medical record system.

           ----------------------------------------------------------------------------------------
           ---------------

      5. Data Analysis, Statistical and Pharmacokinetic Analysis

        1. For clinical data, continuous variables are expressed are as means ± standard deviation
           and analyzed with t-test. Categorical variables are presented as numbers (percentages)
           and Pearson's χ 2 or Fisher's exact test was used where appropriate. Univariate and
           multivariate logistic regression model and Cox model will be used to analyze risk
           factors for sternal wound infection. Significance was set at P < 0.05. Statistical
           analysis was performed using R, version 3.2.5 (R Foundation for Statistical Computing,
           Vienna, Austria.).

        2. For serum Vancomycin levels, non-compartmental analysis will be conducted with WinNonlin
           software (www.certara.com). The population pharmacokinetics will be analyzed with
           nonlinear mixed-effects modeling using in NONMEN 7.3 (Icon Development Solutions,
           Hanover, MD). Xpose (xpose.sourceforge.net), PsN (psn.sourceforge.net), and R, version
           3.2.5 (R Foundation for Statistical Computing, Vienna, Austria.) were used for
           postprocessing of NONMEM output.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Sternal wound infection condition on postoperative day 7
time frame: postoperative day 7
description: Sternal wound condition evaluate by study nursing practitioner, according to the definition of sternal wound infection based on the Centers for Disease Control and Prevention.
Depths 1 and 2 limited to the subcuticular and subcutaneous layers with no involvement of the sternum are deﬁned as a superﬁcial sternal infection (SSI).
Depths 3 and 4, which involved the sternal bone or wires and collections beneath the sternum, are defined as deep sternal infection (DSI).
A wound was considered infected only if a positive culture was obtained.
The sternal wound condition will be coded as "non-infection", "SSI", "DSI"
measure: Sternal wound infection condition on postoperative day 30
time frame: postoperative day 30
description: Sternal wound condition evaluate by study nursing practitioner, according to the definition of sternal wound infection based on the Centers for Disease Control and Prevention.
Depths 1 and 2 limited to the subcuticular and subcutaneous layers with no involvement of the sternum are deﬁned as a superﬁcial sternal infection (SSI).
Depths 3 and 4, which involved the sternal bone or wires and collections beneath the sternum, are defined as deep sternal infection (DSI).
A wound was considered infected only if a positive culture was obtained.
The sternal wound condition will be coded as "non-infection", "SSI", "DSI"
measure: Sternal wound infection condition on postoperative day 90
time frame: postoperative day 90
description: Sternal wound condition evaluate by study nursing practitioner, according to the definition of sternal wound infection based on the Centers for Disease Control and Prevention.
Depths 1 and 2 limited to the subcuticular and subcutaneous layers with no involvement of the sternum are deﬁned as a superﬁcial sternal infection (SSI).
Depths 3 and 4, which involved the sternal bone or wires and collections beneath the sternum, are defined as deep sternal infection (DSI).
A wound was considered infected only if a positive culture was obtained.
The sternal wound condition will be coded as "non-infection", "SSI", "DSI"
measure: Serum Vancomycin exposure on postoperative day 0
time frame: postoperative day 0
description: Serum Vancomycin concentration (mcg/mL) measured with HPLC (high performance liquid chromatography)
measure: Serum Vancomycin exposure on postoperative day 3
time frame: postoperative day 3
description: Serum Vancomycin concentration (mcg/mL) measured with HPLC (high performance liquid chromatography)
measure: Serum Vancomycin exposure on postoperative day 7
time frame: postoperative day 7
description: Serum Vancomycin concentration (mcg/mL) measured with HPLC (high performance liquid chromatography)
arm group label: Vancomycin group
arm group type: Experimental
description: i. Timing of application: the Vancomycin (China Chemical & Pharmaceutical Co., Ltd., CCPC, Taiwan R.O.C.) paste will be spread on sternal edge immediately after sternotomy and before sternal closure.
ii. Regimen: The Vancomycin paste will be prepared using 2.5 g of Vancomycin powder mixed with 2 ml normal saline for each time. A total of 5 g of Vancomycin powder will be applied during the cardiac surgery.
arm group label: Placebo group
arm group type: Placebo Comparator
description: 2 ml normal saline will be spread on sternal edge immediately after sternotomy and before sternal closure.
intervention type: Drug
intervention name: Vancomycin Hydrochloride
description: Vancomycin will be spread on sternal edge immediately after sternotomy and before sternal closure
arm group label: Vancomycin group
other name: vancomycin® (China Chemical & Pharmaceutical Co., Ltd. (CCPC / Taiwan))
intervention type: Other
intervention name: Normal Saline
description: 2 ml normal saline will be spread on sternal edge immediately after sternotomy and before sternal closure
arm group label: Placebo group
other name: Isotonic Sodium chloride 0.9% 20ml/amp (Sintong Taiwan Biotech Company, Limited.)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: MENG-TA TSAI, MD
role: Principal Investigator
affiliation: National Cheng Kung University Hospital, Tainan, Taiwan
last name: MENG-TA TSAI, MD
phone: +886-2353535
phone ext: 2609
email: dongsar@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: Lazar HL, Ketchedjian A, Haime M, Karlson K, Cabral H. Topical vancomycin in combination with perioperative antibiotics and tight glycemic control helps to eliminate sternal wound infections. J Thorac Cardiovasc Surg. 2014 Sep;148(3):1035-8; 1038-40. doi: 10.1016/j.jtcvs.2014.06.045. Epub 2014 Jul 2.
PMID: 25129595
citation: Lazar HL, Barlam T, Cabral H. The effect of topical vancomycin applied to sternotomy incisions on postoperative serum vancomycin levels. J Card Surg. 2011 Sep;26(5):461-5. doi: 10.1111/j.1540-8191.2011.01300.x.
PMID: 21951032
citation: Lander HL, Ejiofor JI, McGurk S, Tsuyoshi K, Shekar P, Body SC. Vancomycin Paste Does Not Reduce the Incidence of Deep Sternal Wound Infection After Cardiac Operations. Ann Thorac Surg. 2017 Feb;103(2):497-503. doi: 10.1016/j.athoracsur.2016.10.020. Epub 2016 Dec 24.
PMID: 28027730
citation: Vander Salm TJ, Okike ON, Pasque MK, Pezzella AT, Lew R, Traina V, Mathieu R. Reduction of sternal infection by application of topical vancomycin. J Thorac Cardiovasc Surg. 1989 Oct;98(4):618-22.
PMID: 2796369
citation: Lazar HL, Salm TV, Engelman R, Orgill D, Gordon S. Prevention and management of sternal wound infections. J Thorac Cardiovasc Surg. 2016 Oct;152(4):962-72. doi: 10.1016/j.jtcvs.2016.01.060. Epub 2016 Aug 8. No abstract available.
PMID: 27555340
citation: Hamman BL, Stout LY, Theologes TT, Sass DM, da Graca B, Filardo G. Relation between topical application of platelet-rich plasma and vancomycin and severe deep sternal wound infections after a first median sternotomy. Am J Cardiol. 2014 Apr 15;113(8):1415-9. doi: 10.1016/j.amjcard.2013.12.046. Epub 2014 Jan 31.
PMID: 24576548
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Meng-Ta Tsai
investigator title: Assistant Professor, Division of Cardiovascular Surgery, Department of Surgery
mesh term: Infections
mesh term: Wound Infection
mesh term: Vancomycin
sharing ipd: No