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/NCT05990842</url>
    </required_header>
    <id_info>
      <org_study_id>57490822.9.0000.5404</org_study_id>
      <nct_id>NCT05990842</nct_id>
    </id_info>
    <brief_title>&quot;Enhancing Surgical Safety in Developing Nations: Investigating Antibiotics' Role in Hand Surgeries.&quot;</brief_title>
    <official_title>&quot;Antibiotic Prophylaxis in Clean Soft Tissue Hand Surgery Among a Population in a Developing Country: A Randomized, Parallel, Triple-Blind, Placebo-Controlled Clinical Trial&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marcos Felipe Marcatto de Abreu</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Campinas, Brazil</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 goal of this clinical trial is to compare the use of antibiotics with no use in people&#xD;
        undergoing soft tissue hand surgery in developing countries.&#xD;
  &#xD;
        The main question it aims to answer is:&#xD;
  &#xD;
        • Is an antibiotic necessary for this type of surgery in this population? Researchers will&#xD;
        compare a group of patients who receives antibiotics during the surgical procedure with a&#xD;
        group who receives no antibiotics to see if infection rates are the same.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 8, 2023</start_date>
    <completion_date type="Anticipated">September 8, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 8, 2025</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>Surgical wound infection</measure>
      <time_frame>30 days</time_frame>
      <description>CDC protocol for surgical wound infection surveillance</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">51</enrollment>
    <condition>Soft Tissue Injuries</condition>
    <arm_group>
      <arm_group_label>antibiotic prophylaxis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Antibiotic</intervention_name>
      <description>the individual will receive 1 dose of antibiotic during anesthetic induction</description>
      <arm_group_label>antibiotic prophylaxis</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>placebo</intervention_name>
      <description>the individual will receive 10 ml of saline during anesthetic induction</description>
      <arm_group_label>placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  individuals with clean soft tissue conditions of the upper limb requiring surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  abandonment of treatment&#xD;
  &#xD;
            -  ASA &gt; 3&#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>Marcos M de Abreu, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Campinas, Brazil</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marcos M Abreu, MD</last_name>
      <phone>+55 19 3521-7512</phone>
      <email>marcatto@unicamp.br</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 6, 2023</last_update_submitted>
    <last_update_submitted_qc>August 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Campinas, Brazil</investigator_affiliation>
      <investigator_full_name>Marcos Felipe Marcatto de Abreu</investigator_full_name>
      <investigator_title>Medical Doctor</investigator_title>
    </responsible_party>
    <keyword>antibiotic prophylaxis</keyword>
    <keyword>hand surgery</keyword>
    <keyword>orthopedic surgery</keyword>
    <keyword>postoperative care</keyword>
    <keyword>surgical wound infection</keyword>
    <keyword>developing country</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Soft Tissue Injuries</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anti-Bacterial Agents</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>all data will be made available, with the exception of the name of the participant</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
      <ipd_time_frame>30 days after study publication</ipd_time_frame>
      <ipd_access_criteria>peer reviewer of a scientific magazine</ipd_access_criteria>
    </patient_data>
    <!-- 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/NCT05990842
  org study id: 57490822.9.0000.5404
  nct id: NCT05990842
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the use of antibiotics with no use in people
        undergoing soft tissue hand surgery in developing countries.
  
        The main question it aims to answer is:
  
        • Is an antibiotic necessary for this type of surgery in this population? Researchers will
        compare a group of patients who receives antibiotics during the surgical procedure with a
        group who receives no antibiotics to see if infection rates are the same.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Surgical wound infection
  time frame: 30 days
  description: CDC protocol for surgical wound infection surveillance
  arm group label: antibiotic prophylaxis
  arm group type: Experimental
  arm group label: placebo
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Antibiotic
  description: the individual will receive 1 dose of antibiotic during anesthetic induction
  arm group label: antibiotic prophylaxis
  intervention type: Other
  intervention name: placebo
  description: the individual will receive 10 ml of saline during anesthetic induction
  arm group label: placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marcos M de Abreu, MD
  role: Principal Investigator
  affiliation: University of Campinas, Brazil
  last name: Marcos M Abreu, MD
  phone: +55 19 3521-7512
  email: marcatto@unicamp.br
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Campinas, Brazil
  investigator full name: Marcos Felipe Marcatto de Abreu
  investigator title: Medical Doctor
  mesh term: Soft Tissue Injuries
  mesh term: Anti-Bacterial Agents
  sharing ipd: Yes
  ipd description: all data will be made available, with the exception of the name of the participant
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code
  ipd time frame: 30 days after study publication
  ipd access criteria: peer reviewer of a scientific magazine