<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/NCT03040960</url>
  </required_header>
  <id_info>
    <org_study_id>38RC16.223</org_study_id>
    <secondary_id>1985246</secondary_id>
    <nct_id>NCT03040960</nct_id>
  </id_info>
  <brief_title>Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery</brief_title>
  <acronym>ISO</acronym>
  <official_title>Risk Factors for Staphylococcus Aureus Surgical Site Infections in Orthopedic and Trauma Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The most commonly identified organism for Surgical Site Infection (SSI) in orthopedic surgery&#xD;
      is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known.&#xD;
      The aim of this study was to evaluated the incidence rate of S. aureus SSI over the years and&#xD;
      risk factors of these infections in a french University Hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Surgical site infections (SSI) in orthopedic surgery are responsible for reduced quality of&#xD;
      life, increased length of hospital stay and costs. The most commonly identified organism is&#xD;
      Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known.The&#xD;
      aim of this study was to evaluate the incidence rate trend of S. aureus SSI over the years&#xD;
      and risk factors of theses infections in a french University Hospital.&#xD;
&#xD;
      The knowledge obtained by this study will enable identification of the surgical patients most&#xD;
      at risk of developping S. aureus SSI, and who would probably benefit most from new&#xD;
      interventions given prophylactically and specifically to prevent S. aureus infections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2016</start_date>
  <completion_date type="Anticipated">August 2018</completion_date>
  <primary_completion_date type="Anticipated">August 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Risk factors of S. aureus surgical site infections.</measure>
    <time_frame>up to 1 year following surgery</time_frame>
    <description>univariate analysis of potential risk factors. Data with p value less than 0.1 were included in a logistic regression model</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence rate trend of S. aureus SSI over the year.</measure>
    <time_frame>from january 1st 2012 to april 30th 2015</time_frame>
    <description>linear regression slope test of S. aureus SSI incidence rates by years</description>
  </secondary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Staphylococcus Aureus</condition>
  <condition>Surgical Wound Infection</condition>
  <condition>Orthopedic Disorder</condition>
  <condition>Traumatology</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing orthopedic or traumatologiy surgeries in Grenoble university hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  orthopedic or traumatology surgeries performed in Grenoble University Hospital,&#xD;
&#xD;
          -  from january 1st 2012 to april 30th 2015,&#xD;
&#xD;
          -  the subject is undergoing one of the following surgical procedures : knee and hip&#xD;
             arthroplasties, osteosynthesis of proximal femur and other osteosynthesis except skull&#xD;
             and spine.&#xD;
&#xD;
          -  the subject is 16 years of age or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non orthopedic or trauma surgery performed in Grenoble University Hospital,&#xD;
&#xD;
          -  spine surgeries,&#xD;
&#xD;
          -  surgeries of the hand, scaphoid and carpal bones.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline landelle, PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Caroline Landelle, PH</last_name>
    <phone>0033476765643</phone>
    <email>clandelle@chu-grenoble.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital, Grenoble Alpes</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caroline Landelle</last_name>
      <phone>0033476765643</phone>
      <email>clandelle@chu-grenoble.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Kalmeijer MD, van Nieuwland-Bollen E, Bogaers-Hofman D, de Baere GA. Nasal carriage of Staphylococcus aureus is a major risk factor for surgical-site infections in orthopedic surgery. Infect Control Hosp Epidemiol. 2000 May;21(5):319-23. doi: 10.1086/501763.</citation>
    <PMID>10823564</PMID>
  </reference>
  <reference>
    <citation>Korol E, Johnston K, Waser N, Sifakis F, Jafri HS, Lo M, Kyaw MH. A systematic review of risk factors associated with surgical site infections among surgical patients. PLoS One. 2013 Dec 18;8(12):e83743. doi: 10.1371/journal.pone.0083743. eCollection 2013.</citation>
    <PMID>24367612</PMID>
  </reference>
  <reference>
    <citation>Marimuthu K, Eisenring MC, Harbarth S, Troillet N. Epidemiology of Staphylococcus aureus Surgical Site Infections. Surg Infect (Larchmt). 2016 Apr;17(2):229-35. doi: 10.1089/sur.2015.055. Epub 2015 Dec 31.</citation>
    <PMID>26720215</PMID>
  </reference>
  <reference>
    <citation>Lepelletier D, Saliou P, Lefebvre A, Lucet JC, Grandbastien B, Bruyere F, Stahl JP, Keita-Perse O, Berthelot P, Aho S; workgroup SF2H. &quot;Preoperative risk management: strategy for Staphylococcus aureus preoperative decolonization&quot; (2013 update). French society of Hospital Hygiene. Med Mal Infect. 2014 Jun;44(6):261-7. doi: 10.1016/j.medmal.2014.04.003. Epub 2014 May 14. No abstract available.</citation>
    <PMID>24835378</PMID>
  </reference>
  <reference>
    <citation>Webster J, Osborne S. Preoperative bathing or showering with skin antiseptics to prevent surgical site infection. Cochrane Database Syst Rev. 2015 Feb 20;2015(2):CD004985. doi: 10.1002/14651858.CD004985.pub5.</citation>
    <PMID>25927093</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>October 10, 2017</last_update_submitted>
  <last_update_submitted_qc>October 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>infection</keyword>
  <keyword>wound infection</keyword>
  <keyword>surgical wound infection</keyword>
  <keyword>Staphylococcal infections</keyword>
  <keyword>wound and injuries</keyword>
  <keyword>postoperative complications</keyword>
  <keyword>Gram-positive bacterial infections</keyword>
  <keyword>bacterial infections</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Staphylococcal Infections</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Musculoskeletal Diseases</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_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/NCT03040960
org study id: 38RC16.223
secondary id: 1985246
nct id: NCT03040960
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The most commonly identified organism for Surgical Site Infection (SSI) in orthopedic surgery
      is Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known.
      The aim of this study was to evaluated the incidence rate of S. aureus SSI over the years and
      risk factors of these infections in a french University Hospital.
Surgical site infections (SSI) in orthopedic surgery are responsible for reduced quality of
      life, increased length of hospital stay and costs. The most commonly identified organism is
      Staphylococcus aureus but risk factors for mono microbial S.aureus SSI are not well-known.The
      aim of this study was to evaluate the incidence rate trend of S. aureus SSI over the years
      and risk factors of theses infections in a french University Hospital.

      The knowledge obtained by this study will enable identification of the surgical patients most
      at risk of developping S. aureus SSI, and who would probably benefit most from new
      interventions given prophylactically and specifically to prevent S. aureus infections.
observational model: Case-Control
time perspective: Prospective
measure: Risk factors of S. aureus surgical site infections.
time frame: up to 1 year following surgery
description: univariate analysis of potential risk factors. Data with p value less than 0.1 were included in a logistic regression model
measure: The incidence rate trend of S. aureus SSI over the year.
time frame: from january 1st 2012 to april 30th 2015
description: linear regression slope test of S. aureus SSI incidence rates by years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Caroline landelle, PH
role: Principal Investigator
affiliation: University Hospital, Grenoble
last name: Caroline Landelle, PH
phone: 0033476765643
email: clandelle@chu-grenoble.fr
facility: 
status: Recruiting
contact: 
country: France
citation: Kalmeijer MD, van Nieuwland-Bollen E, Bogaers-Hofman D, de Baere GA. Nasal carriage of Staphylococcus aureus is a major risk factor for surgical-site infections in orthopedic surgery. Infect Control Hosp Epidemiol. 2000 May;21(5):319-23. doi: 10.1086/501763.
PMID: 10823564
citation: Korol E, Johnston K, Waser N, Sifakis F, Jafri HS, Lo M, Kyaw MH. A systematic review of risk factors associated with surgical site infections among surgical patients. PLoS One. 2013 Dec 18;8(12):e83743. doi: 10.1371/journal.pone.0083743. eCollection 2013.
PMID: 24367612
citation: Marimuthu K, Eisenring MC, Harbarth S, Troillet N. Epidemiology of Staphylococcus aureus Surgical Site Infections. Surg Infect (Larchmt). 2016 Apr;17(2):229-35. doi: 10.1089/sur.2015.055. Epub 2015 Dec 31.
PMID: 26720215
citation: Lepelletier D, Saliou P, Lefebvre A, Lucet JC, Grandbastien B, Bruyere F, Stahl JP, Keita-Perse O, Berthelot P, Aho S; workgroup SF2H. "Preoperative risk management: strategy for Staphylococcus aureus preoperative decolonization" (2013 update). French society of Hospital Hygiene. Med Mal Infect. 2014 Jun;44(6):261-7. doi: 10.1016/j.medmal.2014.04.003. Epub 2014 May 14. No abstract available.
PMID: 24835378
citation: Webster J, Osborne S. Preoperative bathing or showering with skin antiseptics to prevent surgical site infection. Cochrane Database Syst Rev. 2015 Feb 20;2015(2):CD004985. doi: 10.1002/14651858.CD004985.pub5.
PMID: 25927093
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection
mesh term: Staphylococcal Infections
mesh term: Wound Infection
mesh term: Musculoskeletal Diseases
mesh term: Surgical Wound
sharing ipd: No