<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/NCT01698996</url>
  </required_header>
  <id_info>
    <org_study_id>102928</org_study_id>
    <nct_id>NCT01698996</nct_id>
  </id_info>
  <brief_title>A Randomized Blinded Trial of Abscess Management With Packing vs No Packing</brief_title>
  <official_title>A Randomized Blinded Trial of Abscess Management With Packing vs No Packing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adult patients presenting to the emergency department with superficial cutaneous abscesses&#xD;
      will be randomized after incision and drainage to standard care with wound packing or no&#xD;
      packing to determine if there is a difference in the proportion of complications between the&#xD;
      two groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>March 2013</start_date>
  <primary_completion_date type="Anticipated">March 2016</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of complications (defined as a composite of the following: need for repeat incision and drainage by physician, need for admission to hospital, or need for escalation to intravenous antibiotics)</measure>
    <time_frame>7 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of wounds &quot;closed&quot; at 1 week (wound size &lt;0.5 cm length and depth and no drainage)</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Proportion of wounds &quot;closed&quot; at 2 weeks (wound size &lt;0.5 cm length and depth and no drainage)</measure>
    <time_frame>14 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Pain scores (daily pain scores for first week from patient diary)</measure>
    <time_frame>7 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Amount of Pain Medication Used</measure>
    <time_frame>7 days</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Resources Utilized</measure>
    <time_frame>14 days</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Uncomplicated Cutaneous Abscess</condition>
  <arm_group>
    <arm_group_label>No Packing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No Packing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Packing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Packing</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Packing vs No Packing</intervention_name>
    <arm_group_label>No Packing</arm_group_label>
    <arm_group_label>Packing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years&#xD;
&#xD;
          -  Abscess ≤ 5cm in diameter&#xD;
&#xD;
          -  Truncal or extremity location&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Post-operative abscess (abscess in location of operative incision, operation within&#xD;
             the last 4 months)&#xD;
&#xD;
          -  HIV/immunocompromised/transplant recipient/chronic oral steroid use&#xD;
&#xD;
          -  Fever at triage (temp ≥38 degrees Celsius)&#xD;
&#xD;
          -  Abscess secondary to Crohn's&#xD;
&#xD;
          -  Multiple abscesses requiring drainage&#xD;
&#xD;
          -  Prior participation in the study for the same abscess&#xD;
&#xD;
          -  Incision and drainage performed with no packing required, or where abscess cavity is&#xD;
             &lt;1 cm max diameter&#xD;
&#xD;
          -  Bartholins/perigenital, perianal, or facial abscesses&#xD;
&#xD;
          -  Complicated abscesses (fistula, suspicion of muscular extension, consultation/direct&#xD;
             referral to general surgery)&#xD;
&#xD;
          -  Inability to give consent&#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>Amit P Shah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>London Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>March 30, 2015</last_update_submitted>
  <last_update_submitted_qc>March 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Lawson Health Research Institute</investigator_affiliation>
    <investigator_full_name>Amit Shah</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>abscess</keyword>
  <keyword>packing</keyword>
  <keyword>emergency medicine</keyword>
  <keyword>wound care</keyword>
  <keyword>incision and drainage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abscess</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/NCT01698996
org study id: 102928
nct id: NCT01698996
lead sponsor: 
has dmc: No
Adult patients presenting to the emergency department with superficial cutaneous abscesses
      will be randomized after incision and drainage to standard care with wound packing or no
      packing to determine if there is a difference in the proportion of complications between the
      two groups.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of complications (defined as a composite of the following: need for repeat incision and drainage by physician, need for admission to hospital, or need for escalation to intravenous antibiotics)
time frame: 7 days
measure: Proportion of wounds "closed" at 1 week (wound size <0.5 cm length and depth and no drainage)
time frame: 7 days
measure: Proportion of wounds "closed" at 2 weeks (wound size <0.5 cm length and depth and no drainage)
time frame: 14 days
measure: Pain scores (daily pain scores for first week from patient diary)
time frame: 7 days
measure: Amount of Pain Medication Used
time frame: 7 days
measure: Resources Utilized
time frame: 14 days
arm group label: No Packing
arm group type: Active Comparator
description: No Packing
arm group label: Packing
arm group type: Experimental
description: Packing
intervention type: Procedure
intervention name: Packing vs No Packing
arm group label: No Packing
arm group label: Packing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Amit P Shah, MD
role: Principal Investigator
affiliation: London Health Sciences Centre
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Lawson Health Research Institute
investigator full name: Amit Shah
investigator title: Principal Investigator
mesh term: Abscess