<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/NCT03261830</url>
  </required_header>
  <id_info>
    <org_study_id>2008610</org_study_id>
    <nct_id>NCT03261830</nct_id>
  </id_info>
  <brief_title>Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)</brief_title>
  <official_title>Antibiotics Usage in Pediatric Orthopaedic Percutaneous Surgery (APOPS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sumit Gupta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Missouri-Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Missouri-Columbia</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine if antibiotics affect the outcome after percutaneous&#xD;
      surgery for pediatric supracondylar humerus fractures. The patient population will be&#xD;
      recruited from the cohort presenting to Women and Children's Hospital for percutaneous&#xD;
      fixation of pediatric supracondylar humerus fractures who meet the eligibility criteria and&#xD;
      consent to taking part in the study. Patients will be followed up for 3-6 weeks depending on&#xD;
      age, and will be evaluated on the presence or absence superficial or deep infection, Visual&#xD;
      Analog Scale pain scores, time to healing, need for repeat casting, and loss of fixation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This patient population will be recruited from the cohort presenting to Women and Children's&#xD;
      Hospital for percutaneous fixation of pediatric supracondylar humerus fractures. Participants&#xD;
      will be asked to assent to take part in the study and their parents or guardian will be asked&#xD;
      to sign an informed consent. Patients will be randomized to a treatment group that receives&#xD;
      one dose of pre-operative antibiotics or one that does not. Patients randomized to&#xD;
      preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up&#xD;
      to 600mg IV in cases of documented allergy to cefazolin. Patients randomized to the&#xD;
      no-antibiotic group will receive a saline placebo. The resident, anesthesiologist,&#xD;
      circulating nurse and other operating room staff will be instructed to not reveal the&#xD;
      patient's randomization to the attending physician so as not to interfere with blinding.&#xD;
&#xD;
      The patient will then undergo closed reduction percutaneous pinning of supracondylar humerus&#xD;
      fracture. Final AP and lateral fluoroscopic images in the case will be taken. The patient&#xD;
      will be discharged from the hospital when pain is controlled with standard oral pain&#xD;
      medications and all goals of inpatient management have been achieved. No patients will&#xD;
      receive post-operative antibiotics regardless of randomization group as is the existing&#xD;
      standard of care. Patients will be scheduled to follow up in 3-6 weeks depending on age. At&#xD;
      that time the cast will be removed and AP and lateral radiographs will be used to assess&#xD;
      healing. The pins will be removed in clinic and a soft dressing applied to the elbow region.&#xD;
&#xD;
      In cases of excessive pain or cast loosening the patient may be seen in clinic earlier with&#xD;
      radiographs and physical exam as indicated. If the attending physician determines that a deep&#xD;
      or superficial infection is present at any time during the treatment period the patient will&#xD;
      be categorized as infected. If no infection is detected at an earlier-scheduled appointment&#xD;
      the patient will be recasted and instructed to follow up as previously scheduled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 18, 2017</start_date>
  <completion_date type="Actual">March 10, 2023</completion_date>
  <primary_completion_date type="Actual">March 10, 2023</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>Patients will be randomized in that one group receives one dose of pre-operative antibiotics or one that does not.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomization envelops will be created. Attending surgeons/Investigators will be blinded. Participant will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of Post-Operative Infection</measure>
    <time_frame>Six weeks</time_frame>
    <description>The primary outcome measure will be the presence of infection as judged by the blinded attending surgeon at the time of cast removal. A superficial infection is defined as a clinical diagnosis based on increased erythema, granulation tissue or purulence at the pin sites that resolves with a short course of oral antibiotics. A deep infection is defined as the presence of septic arthritis or osteomyelitis requiring return to the operating room for debridement or a prolonged course of IV antibiotics. If the attending physician determines that a deep or superficial infection is present at any time during the treatment period the patient will be categorized as infected.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Analog Scale: Pain Score</measure>
    <time_frame>Six weeks</time_frame>
    <description>Subjects rate their pain on a Visual Analog Scale Pain Score from 0-10. 0 being no pain and 10 being the worst pain imaginable.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">168</enrollment>
  <condition>Supracondylar Humerus Fracture</condition>
  <condition>Post Operative Wound Infection</condition>
  <arm_group>
    <arm_group_label>Pre-operative Antibiotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefazolin</intervention_name>
    <description>Primary intervention</description>
    <arm_group_label>Pre-operative Antibiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clindamycin</intervention_name>
    <description>For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.</description>
    <arm_group_label>Pre-operative Antibiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>Placebo Intervention</description>
    <arm_group_label>Saline Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&lt;14 years&#xD;
&#xD;
          -  Open growth plates&#xD;
&#xD;
          -  Gartland type II or III extension type fracture of the distal humerus OR Flexion type&#xD;
             fracture of the distal humerus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need for open reduction&#xD;
&#xD;
          -  Need for antibiotics due to other injuries or conditions during the entire study&#xD;
             period&#xD;
&#xD;
          -  Immunosuppression&#xD;
&#xD;
          -  History of malignancy or metabolic bone disease&#xD;
&#xD;
          -  Open fractures&#xD;
&#xD;
          -  Pre-existing Infection&#xD;
&#xD;
          -  Intra-operative breech of sterile technique&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>13 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sumit Gupta, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Missouri-Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Missouri Health System</name>
      <address>
        <city>Columbia</city>
        <state>Missouri</state>
        <zip>65212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Missouri-Columbia</investigator_affiliation>
    <investigator_full_name>Sumit Gupta</investigator_full_name>
    <investigator_title>Professor, Assistant Clinical - Department of Orthopaedic Surgery</investigator_title>
  </responsible_party>
  <keyword>Antibiotic</keyword>
  <keyword>Pediatric</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Humeral Fractures</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</mesh_term>
    <mesh_term>Cefazolin</mesh_term>
  </intervention_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/NCT03261830
org study id: 2008610
nct id: NCT03261830
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The aim of this study is to determine if antibiotics affect the outcome after percutaneous
      surgery for pediatric supracondylar humerus fractures. The patient population will be
      recruited from the cohort presenting to Women and Children's Hospital for percutaneous
      fixation of pediatric supracondylar humerus fractures who meet the eligibility criteria and
      consent to taking part in the study. Patients will be followed up for 3-6 weeks depending on
      age, and will be evaluated on the presence or absence superficial or deep infection, Visual
      Analog Scale pain scores, time to healing, need for repeat casting, and loss of fixation.
This patient population will be recruited from the cohort presenting to Women and Children's
      Hospital for percutaneous fixation of pediatric supracondylar humerus fractures. Participants
      will be asked to assent to take part in the study and their parents or guardian will be asked
      to sign an informed consent. Patients will be randomized to a treatment group that receives
      one dose of pre-operative antibiotics or one that does not. Patients randomized to
      preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up
      to 600mg IV in cases of documented allergy to cefazolin. Patients randomized to the
      no-antibiotic group will receive a saline placebo. The resident, anesthesiologist,
      circulating nurse and other operating room staff will be instructed to not reveal the
      patient's randomization to the attending physician so as not to interfere with blinding.

      The patient will then undergo closed reduction percutaneous pinning of supracondylar humerus
      fracture. Final AP and lateral fluoroscopic images in the case will be taken. The patient
      will be discharged from the hospital when pain is controlled with standard oral pain
      medications and all goals of inpatient management have been achieved. No patients will
      receive post-operative antibiotics regardless of randomization group as is the existing
      standard of care. Patients will be scheduled to follow up in 3-6 weeks depending on age. At
      that time the cast will be removed and AP and lateral radiographs will be used to assess
      healing. The pins will be removed in clinic and a soft dressing applied to the elbow region.

      In cases of excessive pain or cast loosening the patient may be seen in clinic earlier with
      radiographs and physical exam as indicated. If the attending physician determines that a deep
      or superficial infection is present at any time during the treatment period the patient will
      be categorized as infected. If no infection is detected at an earlier-scheduled appointment
      the patient will be recasted and instructed to follow up as previously scheduled.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomized in that one group receives one dose of pre-operative antibiotics or one that does not.
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Randomization envelops will be created. Attending surgeons/Investigators will be blinded. Participant will be blinded.
measure: Presence of Post-Operative Infection
time frame: Six weeks
description: The primary outcome measure will be the presence of infection as judged by the blinded attending surgeon at the time of cast removal. A superficial infection is defined as a clinical diagnosis based on increased erythema, granulation tissue or purulence at the pin sites that resolves with a short course of oral antibiotics. A deep infection is defined as the presence of septic arthritis or osteomyelitis requiring return to the operating room for debridement or a prolonged course of IV antibiotics. If the attending physician determines that a deep or superficial infection is present at any time during the treatment period the patient will be categorized as infected.
measure: Visual Analog Scale: Pain Score
time frame: Six weeks
description: Subjects rate their pain on a Visual Analog Scale Pain Score from 0-10. 0 being no pain and 10 being the worst pain imaginable.
arm group label: Pre-operative Antibiotics
arm group type: Active Comparator
description: Patients randomized to preoperative antibiotics will receive 25mg/kg cefazolin IV up to 1g or clindamycin 10mg/kg up to 600mg IV in cases of documented allergy to cefazolin.
arm group label: Saline Placebo
arm group type: Placebo Comparator
description: Patients randomized to the no-antibiotic group will receive a saline placebo. This placebo will consist of a 10 mL pre-filled syringe of normal saline.
intervention type: Drug
intervention name: Cefazolin
description: Primary intervention
arm group label: Pre-operative Antibiotics
intervention type: Drug
intervention name: Clindamycin
description: For use in Pre-operative Antibiotics arm in cases of documented allergy to primary intervention.
arm group label: Pre-operative Antibiotics
intervention type: Drug
intervention name: Saline
description: Placebo Intervention
arm group label: Saline Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: 13 Years
healthy volunteers: No
last name: Sumit Gupta, MD
role: Principal Investigator
affiliation: University of Missouri-Columbia
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Missouri-Columbia
investigator full name: Sumit Gupta
investigator title: Professor, Assistant Clinical - Department of Orthopaedic Surgery
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Humeral Fractures
mesh term: Surgical Wound
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate
mesh term: Cefazolin