xml: <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/NCT06033534</url>
    </required_header>
    <id_info>
      <org_study_id>ATinFE</org_study_id>
      <nct_id>NCT06033534</nct_id>
    </id_info>
    <brief_title>Evaluation of STIMULAN Device and AI Model in Preventing Fracture Infections: A Randomized Study</brief_title>
    <official_title>Safety and Efficacy Evaluation of the STIMULAN Device for the Slow Release of Antibiotics in Exposed Fractures in the Prevention of Infections, and Creation of an AI Predictive Model for the Risk of Infections: a Prospective, Monocentric, Randomized, Blind Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Università Vita-Salute San Raffaele</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Università Vita-Salute San Raffaele</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, single-center, double-blind randomized clinical trial aimed at&#xD;
        evaluating the efficacy and safety of the extended-release antibiotic device, STIMULAN, in&#xD;
        preventing infections in patients with open fractures. The study will enroll 40 patients from&#xD;
        IRCSS San Raffaele's Emergency Department and Orthopedics and Traumatology Unit. Patients&#xD;
        will be stratified into high-risk and low-risk infectious subgroups and randomized into&#xD;
        either the intervention group receiving the antibiotic device or the control group receiving&#xD;
        no device. The follow-up period will last for 5 days, with data collection at specified&#xD;
        intervals. Standard laboratory tests will be utilized to monitor the patient's inflammatory&#xD;
        response.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, single-center, randomized clinical trial with a double-blind&#xD;
        design for both the patient and the evaluator. The aim is to assess the efficacy and safety&#xD;
        of the extended-release antibiotic device STIMULAN in preventing infections in patients with&#xD;
        open fractures.&#xD;
  &#xD;
        The trial will be a randomized study that will enroll two cohorts of patients with open&#xD;
        fractures, sourced from both the Emergency Department of IRCSS San Raffaele and the&#xD;
        Orthopedics and Traumatology Unit. Fractures will be classified according to the Gustilo&#xD;
        Classification. Patients requiring surgical repair of the exposed fracture will be randomized&#xD;
        to receive either the extended-release antibiotic device or no device at all. The&#xD;
        randomization of this study is stratified, with a 1:1 ratio, and 40 patients will be divided&#xD;
        into two groups:&#xD;
  &#xD;
        Intervention group: extended-release antibiotic device Control group: no device&#xD;
  &#xD;
        Two stratification subgroups will be included:&#xD;
  &#xD;
        High-risk infectious subgroup Low-risk infectious subgroup For the definition of&#xD;
        stratification, please refer to Section 9.1, Risk Assessment Table for Stratification.&#xD;
  &#xD;
        Patients will be followed for a duration of 5 days, and follow-up data will be collected at&#xD;
        established intervals. According to recent studies, the onset of initial infections occurs&#xD;
        between 24 and 72 hours following the episode of open fracture. Therefore, a 5-day period is&#xD;
        deemed a reasonable time frame for constant monitoring. Standard-of-care laboratory tests&#xD;
        such as white blood cell count, C-reactive protein, erythrocyte sedimentation rate, and&#xD;
        procalcitonin will also be collected and analyzed to determine the patient's inflammatory&#xD;
        response.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 1, 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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Infected Open Fracture</measure>
      <time_frame>5 days</time_frame>
      <description>The primary outcome measure of this clinical trial is the incidence of bacterial infections following surgical intervention for open fractures in both the intervention and control arms. This will be quantified as the number of confirmed bacterial infections per total number of participants in each arm, expressed as a percentage.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Open Fracture</condition>
    <arm_group>
      <arm_group_label>STIMULAN DEVICE USED</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients allocated to this arm will receive an extended-release antibiotic device, STIMULAN, as a prophylactic measure against bacterial infection post-fracture repair surgery. The device is designed to release antibiotics in a controlled manner over a specified period of time.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>STIMULAN DEVICE NOT USED</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients in this arm will undergo the surgical repair of their open fracture but will not receive any antibiotic device for prophylaxis against bacterial infections.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>STIMULAN</intervention_name>
      <description>Procedures:&#xD;
  Surgical repair of the open fracture, as per standard-of-care guidelines. Insertion of the STIMULAN device at the site of the fracture. Standard post-operative care, including monitoring of inflammatory markers and clinical signs of infection.</description>
      <arm_group_label>STIMULAN DEVICE USED</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Open fractures of any type and location Fractures classified as Gustilo-Anderson Type I,&#xD;
          II, IIIa, IIIb, IIIc Patients requiring surgical intervention for fracture correction&#xD;
          Patients with no contraindications for antibiotic treatment Patients providing informed&#xD;
          consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients with active infections Patients with a history of allergies or adverse reactions&#xD;
          to the antibiotics used in the extended-release device Patients with severe renal or&#xD;
          hepatic insufficiency Non-cooperative patients or those who are unable to adhere to&#xD;
          follow-up visits or study procedures due to physical or mental limitations or severe&#xD;
          neurological illness Patients who have undergone spinal surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Giacomo Placella, MD</last_name>
      <phone>3927123432</phone>
      <phone_ext>+39</phone_ext>
      <email>giacomo.placella@hsr.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ospedale San Raffaele</name>
        <address>
          <city>Milan</city>
          <zip>20132</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nicolo Biavardi</last_name>
        <phone>+393663408250</phone>
        <email>n.biavardi@studenti.unisr.it</email>
      </contact>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Università Vita-Salute San Raffaele</investigator_affiliation>
      <investigator_full_name>Professor Giacomo Placella</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fractures, Bone</mesh_term>
      <mesh_term>Fractures, Open</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06033534
  org study id: ATinFE
  nct id: NCT06033534
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, single-center, double-blind randomized clinical trial aimed at
        evaluating the efficacy and safety of the extended-release antibiotic device, STIMULAN, in
        preventing infections in patients with open fractures. The study will enroll 40 patients from
        IRCSS San Raffaele's Emergency Department and Orthopedics and Traumatology Unit. Patients
        will be stratified into high-risk and low-risk infectious subgroups and randomized into
        either the intervention group receiving the antibiotic device or the control group receiving
        no device. The follow-up period will last for 5 days, with data collection at specified
        intervals. Standard laboratory tests will be utilized to monitor the patient's inflammatory
        response.
  This study is a prospective, single-center, randomized clinical trial with a double-blind
        design for both the patient and the evaluator. The aim is to assess the efficacy and safety
        of the extended-release antibiotic device STIMULAN in preventing infections in patients with
        open fractures.
  
        The trial will be a randomized study that will enroll two cohorts of patients with open
        fractures, sourced from both the Emergency Department of IRCSS San Raffaele and the
        Orthopedics and Traumatology Unit. Fractures will be classified according to the Gustilo
        Classification. Patients requiring surgical repair of the exposed fracture will be randomized
        to receive either the extended-release antibiotic device or no device at all. The
        randomization of this study is stratified, with a 1:1 ratio, and 40 patients will be divided
        into two groups:
  
        Intervention group: extended-release antibiotic device Control group: no device
  
        Two stratification subgroups will be included:
  
        High-risk infectious subgroup Low-risk infectious subgroup For the definition of
        stratification, please refer to Section 9.1, Risk Assessment Table for Stratification.
  
        Patients will be followed for a duration of 5 days, and follow-up data will be collected at
        established intervals. According to recent studies, the onset of initial infections occurs
        between 24 and 72 hours following the episode of open fracture. Therefore, a 5-day period is
        deemed a reasonable time frame for constant monitoring. Standard-of-care laboratory tests
        such as white blood cell count, C-reactive protein, erythrocyte sedimentation rate, and
        procalcitonin will also be collected and analyzed to determine the patient's inflammatory
        response.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Double (Participant, Investigator)
  measure: Infected Open Fracture
  time frame: 5 days
  description: The primary outcome measure of this clinical trial is the incidence of bacterial infections following surgical intervention for open fractures in both the intervention and control arms. This will be quantified as the number of confirmed bacterial infections per total number of participants in each arm, expressed as a percentage.
  arm group label: STIMULAN DEVICE USED
  arm group type: Experimental
  description: Patients allocated to this arm will receive an extended-release antibiotic device, STIMULAN, as a prophylactic measure against bacterial infection post-fracture repair surgery. The device is designed to release antibiotics in a controlled manner over a specified period of time.
  arm group label: STIMULAN DEVICE NOT USED
  arm group type: No Intervention
  description: Patients in this arm will undergo the surgical repair of their open fracture but will not receive any antibiotic device for prophylaxis against bacterial infections.
  intervention type: Device
  intervention name: STIMULAN
  description: Procedures:
  Surgical repair of the open fracture, as per standard-of-care guidelines. Insertion of the STIMULAN device at the site of the fracture. Standard post-operative care, including monitoring of inflammatory markers and clinical signs of infection.
  arm group label: STIMULAN DEVICE USED
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: 65 Years
  healthy volunteers: No
  last name: Giacomo Placella, MD
  phone: 3927123432
  phone ext: +39
  email: giacomo.placella@hsr.it
  facility: 
  status: Recruiting
  contact: 
  country: Italy
  responsible party type: Principal Investigator
  investigator affiliation: Università Vita-Salute San Raffaele
  investigator full name: Professor Giacomo Placella
  investigator title: Associate Professor
  mesh term: Fractures, Bone
  mesh term: Fractures, Open