<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/NCT03275519</url>
  </required_header>
  <id_info>
    <org_study_id>IRB# 203532</org_study_id>
    <nct_id>NCT03275519</nct_id>
  </id_info>
  <brief_title>Antibiotic Use in Distal Hypospadias Repair</brief_title>
  <official_title>Randomized Trial of Antibiotic Prophylaxis for Prevention of Symptomatic UTI in Stented, Distal Hypospadias Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Arkansas Children's Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Arkansas Children's Hospital Research Institute</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>
      Hypospadias is a common condition where the opening of the penis is not located at the tip,&#xD;
      but along the underside of the penis. It is estimated to occur in 1/300 live male births,&#xD;
      making it one of the most common birth defects. Degrees of hypospadias ranged from minor to&#xD;
      severe depending on the location of the opening. Surgical repair is often required and&#xD;
      involves placement of a catheter for the urine to drain with known urinary colonization found&#xD;
      on prior retrospective studies. The current practice of using preventative antibiotics as&#xD;
      long as the catheter is in place is conflicting with resent studies that show antibiotics may&#xD;
      not be necessary to prevent urinary tract infections (UTIs).&#xD;
&#xD;
      The purpose of this study was to see how common symptomatic UTIs were after hypospadias&#xD;
      repair surgery; and to see whether routine antibiotic use after surgery affected the rate of&#xD;
      UTIs. Subjects were randomized to either receive antibiotics or no antibiotics after distal&#xD;
      hypospadias repair. The research coordinator made follow-up phone calls with the family and&#xD;
      the primary care provider (PCP) after stent removal, 30 days post surgery and after the 3&#xD;
      month post surgical visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Males undergoing distal hypospadias repair involving stent placement were randomized to&#xD;
      either receive or not to receive antibiotics post-operative. All subjects did not receive&#xD;
      intra-operative antibiotics. Routine follow-up included having the stent removed one week&#xD;
      post-op and a return visit at 3 months. The research nurse made follow-up phone calls to the&#xD;
      family or the (PCP) one week after the stent was removed and at one month post-op to see how&#xD;
      things were going with the child and again after teh 3 month post surgical visit, if the&#xD;
      subject did not return after multiple rescheduling attempts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 19, 2015</start_date>
  <completion_date type="Actual">April 19, 2017</completion_date>
  <primary_completion_date type="Actual">February 17, 2017</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>
    <intervention_model_description>Using the block randomization procedures, a subject was assigned to a study group by computer using the REDCap randomization module. Subjects were randomized to receive post operative antibiotics or to not receive any antibiotics postoperative.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Prevalence of symptomatic UTI within 30 days post-surgery</measure>
    <time_frame>30 days post surgery</time_frame>
    <description>Assess the prevalence of symptomatic UTI in subjects receiving standard of care dispensation of prophylaxis versus subjects selected to an antibiotic-sparing cohort.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of surgical site infections (SSIs) and complications of hypospadias repair</measure>
    <time_frame>Approximately post surgery: 2 weeks (stent is in approximately 1 week and then 1 week after the stent is removed); 30 days; and 3 months</time_frame>
    <description>Surgical site infections (SSIs) are measured using physical assessments at the stent removal visit. Complications of hypospadias repair (urethral fistula, meatal stenosis, dehiscence, and diverticulum) are measured using physical assessments at the stent removal visit and/or contact with the family or the PCP office 1 week after the stent removal; at the 30 day post operative time point; and at the 3 month follow-op visit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Hypospadias</condition>
  <arm_group>
    <arm_group_label>Antibiotics prophylaxis cohort</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were prescribed prophylactic antibiotics after the hypospadias surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Antibiotic-sparing cohort</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were not prescribed prophylactic antibiotics after the hypospadias surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Randomization to not receive prophylactic antibiotics after surgery.</intervention_name>
    <description>No antibiotics were ordered after surgery.</description>
    <arm_group_label>Antibiotic-sparing cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Randomization to receive prophylactic antibiotics after surgery</intervention_name>
    <description>In general, the antibiotic given is a combination sulfamethoxazole/ trimethoprim oral suspension (2-3 mg trimethoprim/kg by mouth once a day); or if indicated, nitrofurantoin (1mg/kg by mouth once daily). All subjects did not receive intraoperative antibiotics.</description>
    <arm_group_label>Antibiotics prophylaxis cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males undergoing primary distal hypospadias repair with open urethral stent drainage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males undergoing fistula repair or glandular hypospadias repair without incontinent&#xD;
             urethral stent drainage and hypospadias repair of mid or more proximal degrees of&#xD;
             hypospadias were excluded from this study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Males undergoing hypospadias repair on their penis.</gender_description>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>6 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Canon</last_name>
    <role>Principal Investigator</role>
    <affiliation>Arkansas Children's Hospital, Pediatric Urology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Arkansas Children's Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 7, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>distal hypospadias repair</keyword>
  <keyword>urinary tract infection</keyword>
  <keyword>prophylactic antibiotic use</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypospadias</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Antibiotics, Antitubercular</mesh_term>
  </intervention_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/NCT03275519
org study id: IRB# 203532
nct id: NCT03275519
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Hypospadias is a common condition where the opening of the penis is not located at the tip,
      but along the underside of the penis. It is estimated to occur in 1/300 live male births,
      making it one of the most common birth defects. Degrees of hypospadias ranged from minor to
      severe depending on the location of the opening. Surgical repair is often required and
      involves placement of a catheter for the urine to drain with known urinary colonization found
      on prior retrospective studies. The current practice of using preventative antibiotics as
      long as the catheter is in place is conflicting with resent studies that show antibiotics may
      not be necessary to prevent urinary tract infections (UTIs).

      The purpose of this study was to see how common symptomatic UTIs were after hypospadias
      repair surgery; and to see whether routine antibiotic use after surgery affected the rate of
      UTIs. Subjects were randomized to either receive antibiotics or no antibiotics after distal
      hypospadias repair. The research coordinator made follow-up phone calls with the family and
      the primary care provider (PCP) after stent removal, 30 days post surgery and after the 3
      month post surgical visit.
Males undergoing distal hypospadias repair involving stent placement were randomized to
      either receive or not to receive antibiotics post-operative. All subjects did not receive
      intra-operative antibiotics. Routine follow-up included having the stent removed one week
      post-op and a return visit at 3 months. The research nurse made follow-up phone calls to the
      family or the (PCP) one week after the stent was removed and at one month post-op to see how
      things were going with the child and again after teh 3 month post surgical visit, if the
      subject did not return after multiple rescheduling attempts.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Using the block randomization procedures, a subject was assigned to a study group by computer using the REDCap randomization module. Subjects were randomized to receive post operative antibiotics or to not receive any antibiotics postoperative.
primary purpose: Treatment
masking: None (Open Label)
measure: Prevalence of symptomatic UTI within 30 days post-surgery
time frame: 30 days post surgery
description: Assess the prevalence of symptomatic UTI in subjects receiving standard of care dispensation of prophylaxis versus subjects selected to an antibiotic-sparing cohort.
measure: Evaluation of surgical site infections (SSIs) and complications of hypospadias repair
time frame: Approximately post surgery: 2 weeks (stent is in approximately 1 week and then 1 week after the stent is removed); 30 days; and 3 months
description: Surgical site infections (SSIs) are measured using physical assessments at the stent removal visit. Complications of hypospadias repair (urethral fistula, meatal stenosis, dehiscence, and diverticulum) are measured using physical assessments at the stent removal visit and/or contact with the family or the PCP office 1 week after the stent removal; at the 30 day post operative time point; and at the 3 month follow-op visit.
arm group label: Antibiotics prophylaxis cohort
arm group type: Active Comparator
description: Subjects were prescribed prophylactic antibiotics after the hypospadias surgery.
arm group label: Antibiotic-sparing cohort
arm group type: Active Comparator
description: Subjects were not prescribed prophylactic antibiotics after the hypospadias surgery.
intervention type: Other
intervention name: Randomization to not receive prophylactic antibiotics after surgery.
description: No antibiotics were ordered after surgery.
arm group label: Antibiotic-sparing cohort
intervention type: Other
intervention name: Randomization to receive prophylactic antibiotics after surgery
description: In general, the antibiotic given is a combination sulfamethoxazole/ trimethoprim oral suspension (2-3 mg trimethoprim/kg by mouth once a day); or if indicated, nitrofurantoin (1mg/kg by mouth once daily). All subjects did not receive intraoperative antibiotics.
arm group label: Antibiotics prophylaxis cohort
criteria: 
gender: Male
gender based: Yes
gender description: Males undergoing hypospadias repair on their penis.
minimum age: 3 Months
maximum age: 6 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Canon
role: Principal Investigator
affiliation: Arkansas Children's Hospital, Pediatric Urology
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypospadias
mesh term: Anti-Bacterial Agents
mesh term: Antibiotics, Antitubercular
sharing ipd: No