<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/NCT02996656</url>
  </required_header>
  <id_info>
    <org_study_id>PAPA</org_study_id>
    <nct_id>NCT02996656</nct_id>
  </id_info>
  <brief_title>Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery</brief_title>
  <acronym>PAPA</acronym>
  <official_title>Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery: A Double Blinded Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Université de Montréal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stryker Trauma GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hopital du Sacre-Coeur de Montreal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Université de Montréal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction&#xD;
      for all orthopaedic procedure with implantation of internal fixation device. With the&#xD;
      increasing rate of identified P. acnes shoulder surgery infection despite the use of&#xD;
      recommended skin preparation and preoperative prophylactic antibiotics, a question arises; Is&#xD;
      Cefazolin the most effective prophylactic antibiotic for shoulder surgery? The objective of&#xD;
      this study is to determine if Ceftriaxone is superior to Cefazolin as a prophylactic&#xD;
      antibiotic for skin colonization with P. acnes in primary shoulder surgery&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a double blinded randomized clinical trial comparing two different prophylactic&#xD;
      antibiotics used for primary open shoulder surgery. The participants are volunteer patients&#xD;
      scheduled for a primary open elective or trauma shoulder surgery. Patients with positive MRSA&#xD;
      screening test will be excluded from the randomised study as they will receive vancomycin for&#xD;
      prophylaxis. If they accept to participate, they will be included in the observational MRSA+&#xD;
      arm. The investigators will take from the participants the same data as the randomised&#xD;
      patients and the investigators will take biopsies.&#xD;
&#xD;
      4 equals group will be form: Female-elective: 22 envelops, 11 cefazolin, 11 ceftriaxone in a&#xD;
      randomly order Female-trauma: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order&#xD;
      Male-elective: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order Male-trauma: 22&#xD;
      envelops, 11 cefazolin, 11 ceftriaxone in a randomly order The surgeons, anesthesiologist,&#xD;
      patients and laboratory technician, microbiologist will be blinded to the antibiotics&#xD;
      received by the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin Biopsy</measure>
    <time_frame>At the initial surgery</time_frame>
    <description>Number of bacteria identified in five skin biopsies taken at the surgical site</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MRSA observance</measure>
    <time_frame>1 year following the surgery</time_frame>
    <description>Observe the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection</measure>
    <time_frame>1 year following the surgery</time_frame>
    <description>Assessing the appearance of C Difficile infection at 1 year post-op</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection #2</measure>
    <time_frame>1 year following the surgery</time_frame>
    <description>Assessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection #3</measure>
    <time_frame>1 year following the surgery</time_frame>
    <description>Follow all the participants for one year to observe superficial tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infection #4</measure>
    <time_frame>1 year following the surgery</time_frame>
    <description>Follow all the participants for one year to observe deep tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">88</enrollment>
  <condition>Propionibacterium Infection</condition>
  <arm_group>
    <arm_group_label>Cefazolin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During an open shoulder surgery, the Cefazolin will be administered to some patient. The Cefazolin is a first generation cephalosporin. It is a beta lactam which targets gram positive cocci and some gram negative bacilli. The INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction for all orthopaedic procedure with implantation of internal fixation device. The dosage is 2g intravenous if the patient weights less than 120kg or 3g if the patient weights more than 120kg. The dose should be repeated if the procedure lasts for more than three hours or if the blood loss is greater than 1500mL.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ceftriaxone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During an open shoulder surgery, the Ceftriaxone will be administered to some patient. The Ceftriaxone is a third generation cephalosporin. It targets gram positive cocci such as staphylococcus and streptococcus, gram negative bacilli and some anaerobes, including P. acnes. The prophylactic dose is of 2g IV given a minimum of 30 minutes prior to skin incision. It is effective 12h so no other dose is needed during surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefazolin</intervention_name>
    <description>Antibiotic that will be give before a Trauma or elective open shoulder surgery</description>
    <arm_group_label>Cefazolin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ceftriaxone</intervention_name>
    <description>Antibiotic that will be give before a Trauma or elective open shoulder surgery</description>
    <arm_group_label>Ceftriaxone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years and older&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Presenting normal skin on the shoulder aria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Used antibiotics or treated their skin with antibiotic gel, alcohol gel or cream or&#xD;
             acne treatment in the last three months&#xD;
&#xD;
          -  Active infection at the surgical site or anywhere&#xD;
&#xD;
          -  Affected shoulder previously received radiotherapy&#xD;
&#xD;
          -  Allergic to one of the antimicrobial prophylaxis used&#xD;
&#xD;
          -  Open fracture&#xD;
&#xD;
          -  Life threatening or a limb threatening pathology&#xD;
&#xD;
          -  Liver or kidney failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dominique Rouleau, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Université de Montréal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dominique Rouleau, MD</last_name>
    <phone>514-338-2222</phone>
    <phone_ext>3427</phone_ext>
    <email>dominique_rouleau@yahoo.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Karine Tardif</last_name>
    <phone>514-338-2222</phone>
    <phone_ext>3465</phone_ext>
    <email>karinetardif2@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital du Sacré-Cœur de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4J 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique Rouleau</last_name>
      <phone>514-338-2222</phone>
      <phone_ext>2050</phone_ext>
      <email>dominique_rouleau@yahoo.ca</email>
    </contact>
    <contact_backup>
      <last_name>Karine Tardif</last_name>
      <phone>514-338-2222</phone>
      <phone_ext>3465</phone_ext>
      <email>karinetardif2@gmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 25, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Université de Montréal</investigator_affiliation>
    <investigator_full_name>Dominique Rouleau</investigator_full_name>
    <investigator_title>Orthopaedic surgeon</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cefazolin</mesh_term>
    <mesh_term>Ceftriaxone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02996656
org study id: PAPA
nct id: NCT02996656
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction
      for all orthopaedic procedure with implantation of internal fixation device. With the
      increasing rate of identified P. acnes shoulder surgery infection despite the use of
      recommended skin preparation and preoperative prophylactic antibiotics, a question arises; Is
      Cefazolin the most effective prophylactic antibiotic for shoulder surgery? The objective of
      this study is to determine if Ceftriaxone is superior to Cefazolin as a prophylactic
      antibiotic for skin colonization with P. acnes in primary shoulder surgery
This is a double blinded randomized clinical trial comparing two different prophylactic
      antibiotics used for primary open shoulder surgery. The participants are volunteer patients
      scheduled for a primary open elective or trauma shoulder surgery. Patients with positive MRSA
      screening test will be excluded from the randomised study as they will receive vancomycin for
      prophylaxis. If they accept to participate, they will be included in the observational MRSA+
      arm. The investigators will take from the participants the same data as the randomised
      patients and the investigators will take biopsies.

      4 equals group will be form: Female-elective: 22 envelops, 11 cefazolin, 11 ceftriaxone in a
      randomly order Female-trauma: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order
      Male-elective: 22 envelops, 11 cefazolin, 11 ceftriaxone in a randomly order Male-trauma: 22
      envelops, 11 cefazolin, 11 ceftriaxone in a randomly order The surgeons, anesthesiologist,
      patients and laboratory technician, microbiologist will be blinded to the antibiotics
      received by the patient.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Skin Biopsy
time frame: At the initial surgery
description: Number of bacteria identified in five skin biopsies taken at the surgical site
measure: MRSA observance
time frame: 1 year following the surgery
description: Observe the patients from de MRSA group which will be receiving Vancomycin as prophylactic antibiotics.
measure: Infection
time frame: 1 year following the surgery
description: Assessing the appearance of C Difficile infection at 1 year post-op
measure: Infection #2
time frame: 1 year following the surgery
description: Assessing the appearance of resistant pathogens colonization (MRSA, VRE, Multiresistant Gram negative Bacillus) 1 year post-op
measure: Infection #3
time frame: 1 year following the surgery
description: Follow all the participants for one year to observe superficial tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital
measure: Infection #4
time frame: 1 year following the surgery
description: Follow all the participants for one year to observe deep tissue infection (as defined by the infection prevention team of Montreal Sacre-Coeur Hospital)
arm group label: Cefazolin
arm group type: Active Comparator
description: During an open shoulder surgery, the Cefazolin will be administered to some patient. The Cefazolin is a first generation cephalosporin. It is a beta lactam which targets gram positive cocci and some gram negative bacilli. The INESS Antibiotic Prophylaxis in Orthopedic Guide recommends the use of Cefazolin at induction for all orthopaedic procedure with implantation of internal fixation device. The dosage is 2g intravenous if the patient weights less than 120kg or 3g if the patient weights more than 120kg. The dose should be repeated if the procedure lasts for more than three hours or if the blood loss is greater than 1500mL.
arm group label: Ceftriaxone
arm group type: Experimental
description: During an open shoulder surgery, the Ceftriaxone will be administered to some patient. The Ceftriaxone is a third generation cephalosporin. It targets gram positive cocci such as staphylococcus and streptococcus, gram negative bacilli and some anaerobes, including P. acnes. The prophylactic dose is of 2g IV given a minimum of 30 minutes prior to skin incision. It is effective 12h so no other dose is needed during surgery.
intervention type: Drug
intervention name: Cefazolin
description: Antibiotic that will be give before a Trauma or elective open shoulder surgery
arm group label: Cefazolin
intervention type: Drug
intervention name: Ceftriaxone
description: Antibiotic that will be give before a Trauma or elective open shoulder surgery
arm group label: Ceftriaxone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dominique Rouleau, MD
role: Principal Investigator
affiliation: Université de Montréal
last name: Dominique Rouleau, MD
phone: 514-338-2222
phone ext: 3427
email: dominique_rouleau@yahoo.ca
last name: Karine Tardif
phone: 514-338-2222
phone ext: 3465
email: karinetardif2@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Université de Montréal
investigator full name: Dominique Rouleau
investigator title: Orthopaedic surgeon
mesh term: Cefazolin
mesh term: Ceftriaxone
sharing ipd: Undecided