<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/NCT01691599</url>
  </required_header>
  <id_info>
    <org_study_id>INFINITI</org_study_id>
    <nct_id>NCT01691599</nct_id>
  </id_info>
  <brief_title>Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India</brief_title>
  <official_title>Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AO Clinical Investigation and Publishing Documentation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AO Innovation Translation Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are to investigate infection rates and management for open and&#xD;
      closed tibia fracture subjects in India treated with internal fixation. These objectives will&#xD;
      be carried out by answering the following questions:&#xD;
&#xD;
        1. What is the infection rate within one year of surgery for open and closed tibia fracture&#xD;
           subjects in India treated with internal fixation?&#xD;
&#xD;
        2. What is the distribution of infection per type of infection, stratified by time (early,&#xD;
           delayed, late) and location (superficial or deep) in open and closed tibia fracture&#xD;
           subjects in India treated with internal fixation?&#xD;
&#xD;
      Secondary objectives&#xD;
&#xD;
        1. How are infections managed in open and closed tibia fracture subjects in India treated&#xD;
           with internal fixation?&#xD;
&#xD;
        2. What is the treatment outcome for open and closed tibia fracture subjects in India&#xD;
           treated with internal fixation?&#xD;
&#xD;
        3. What is the influence of the following clinic and subject factors on the occurrence of&#xD;
           infection within one year for open and closed tibia fracture subjects in India treated&#xD;
           with internal fixation?&#xD;
&#xD;
             1. Hospital standard hygienic and antibiotic protocol for infection prevention&#xD;
&#xD;
             2. Subject demographics&#xD;
&#xD;
             3. Time between injury and surgery and between admission and surgery&#xD;
&#xD;
             4. Fracture type (AO Müller classification)&#xD;
&#xD;
             5. Soft tissue damage (according to the Tscherne classification for closed fractures&#xD;
                or Gustilo classification for open fractures)&#xD;
&#xD;
             6. Fracture management and implant type&#xD;
&#xD;
             7. Surgical details such as duration of surgery&#xD;
&#xD;
        4. Is there a difference in health-related quality of life as measured by the EuroQol-5&#xD;
           Dimensions (EQ-5D) between subjects with and without infections?&#xD;
&#xD;
        5. Is there a difference in the number of complications not related to infection (adverse&#xD;
           events and serious adverse events) between subjects with and without infections?&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of infection</measure>
    <time_frame>From surgery until the date of first documented infection assessed up to 1 year</time_frame>
    <description>LAB (CRP + ESR level, Leukocyte count / diff.) and bacteriology of wound swabs / aspirated liquids and sensitivity testing, if the patient is suspected for a surgical site infection (SSI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life measurement (EQ-5D)</measure>
    <time_frame>Baseline and up to 5 day postoperative and 3months and 6months and 12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">800</enrollment>
  <condition>Tibia Fracture</condition>
  <arm_group>
    <arm_group_label>Tibia fractures</arm_group_label>
    <description>Patients with open and closed tibia fracture treated with internal fixation in India</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with open or closed tibia fractures&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women who are 18 years of age or older.&#xD;
&#xD;
          2. Open or closed tibia fracture treated by internal fixation (plate or nail), or by&#xD;
             external fixation with planned conversion to plate or nail.&#xD;
&#xD;
          3. Ability to understand the content of the subject information / informed consent form&#xD;
             and to be willing to participate in the clinical investigation.&#xD;
&#xD;
          4. Written informed consent. Subjects with bilateral fractures will be included. In these&#xD;
             subjects, the most severe fracture will be the one included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous wound infection or osteomyelitis at the same limb (according to subject&#xD;
             history).&#xD;
&#xD;
          2. Subjects who plan to undergo conversion surgery at a different hospital.&#xD;
&#xD;
          3. Previous fracture with retained hardware in injured extremity that will interfere with&#xD;
             implant fixation.&#xD;
&#xD;
          4. Immunological deficiency disease.&#xD;
&#xD;
          5. Tumor related fractures.&#xD;
&#xD;
          6. Any severe systemic disease: class V-VI of the American Society of Anesthesiologists&#xD;
             (ASA) physical status classification (Appendix 5).&#xD;
&#xD;
          7. Recent history of substance abuse (i.e. recreational drugs, alcohol) that would&#xD;
             preclude reliable assessment.&#xD;
&#xD;
          8. Subject is a prisoner.&#xD;
&#xD;
          9. Participation in any other medical device or medicinal product study within the&#xD;
             previous month that could influence the results of the present study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prakash J Doshi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hi Tech Hospital</name>
      <address>
        <city>Gandhinagar</city>
        <state>Gujarat</state>
        <zip>382006</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. B.R. Ambedkar Medical College Hospital</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560 045</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MOSC Medical College</name>
      <address>
        <city>Kochi</city>
        <state>Kerala</state>
        <zip>625 007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kolhapur Institute of Orthopedics and Trauma</name>
      <address>
        <city>Kolhapur</city>
        <state>Maharashtra</state>
        <zip>416 001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Balabhai Nanavati Hospital</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400 056</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. R. N. Cooper Hospital</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400 056</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jai Hospital Pvt. Ltd.</name>
      <address>
        <city>Nashik</city>
        <state>Maharashtra</state>
        <zip>422 002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sancheti Hospital</name>
      <address>
        <city>Pune</city>
        <state>Maharashtra</state>
        <zip>411005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan</name>
      <address>
        <city>Sangli</city>
        <state>Maharashtra</state>
        <zip>416 416</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Post Graduate Institute of Medical Education and Research</name>
      <address>
        <city>Chandigarh</city>
        <state>Punjab</state>
        <zip>160 012</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mukhopadhaya Orthopaedic Clinic and Research Centre</name>
      <address>
        <city>Bihar</city>
        <zip>800 004</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>July 21, 2021</last_update_submitted>
  <last_update_submitted_qc>July 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infection</keyword>
  <keyword>Open tibia fractures</keyword>
  <keyword>Closed tibia fractures</keyword>
  <keyword>Wound infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Tibial Fractures</mesh_term>
  </condition_browse>
  <!-- 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/NCT01691599
org study id: INFINITI
nct id: NCT01691599
lead sponsor: 
has dmc: No
The objectives of this study are to investigate infection rates and management for open and
      closed tibia fracture subjects in India treated with internal fixation. These objectives will
      be carried out by answering the following questions:

        1. What is the infection rate within one year of surgery for open and closed tibia fracture
           subjects in India treated with internal fixation?

        2. What is the distribution of infection per type of infection, stratified by time (early,
           delayed, late) and location (superficial or deep) in open and closed tibia fracture
           subjects in India treated with internal fixation?

      Secondary objectives

        1. How are infections managed in open and closed tibia fracture subjects in India treated
           with internal fixation?

        2. What is the treatment outcome for open and closed tibia fracture subjects in India
           treated with internal fixation?

        3. What is the influence of the following clinic and subject factors on the occurrence of
           infection within one year for open and closed tibia fracture subjects in India treated
           with internal fixation?

             1. Hospital standard hygienic and antibiotic protocol for infection prevention

             2. Subject demographics

             3. Time between injury and surgery and between admission and surgery

             4. Fracture type (AO Müller classification)

             5. Soft tissue damage (according to the Tscherne classification for closed fractures
                or Gustilo classification for open fractures)

             6. Fracture management and implant type

             7. Surgical details such as duration of surgery

        4. Is there a difference in health-related quality of life as measured by the EuroQol-5
           Dimensions (EQ-5D) between subjects with and without infections?

        5. Is there a difference in the number of complications not related to infection (adverse
           events and serious adverse events) between subjects with and without infections?
observational model: Case-Only
time perspective: Prospective
measure: Occurrence of infection
time frame: From surgery until the date of first documented infection assessed up to 1 year
description: LAB (CRP + ESR level, Leukocyte count / diff.) and bacteriology of wound swabs / aspirated liquids and sensitivity testing, if the patient is suspected for a surgical site infection (SSI)
measure: Change in Quality of life measurement (EQ-5D)
time frame: Baseline and up to 5 day postoperative and 3months and 6months and 12 months
arm group label: Tibia fractures
description: Patients with open and closed tibia fracture treated with internal fixation in India
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: Prakash J Doshi, MD
role: Principal Investigator
affiliation: Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Infections
mesh term: Fractures, Bone
mesh term: Tibial Fractures