<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/NCT01685593</url>
  </required_header>
  <id_info>
    <org_study_id>C.2001.128</org_study_id>
    <nct_id>NCT01685593</nct_id>
  </id_info>
  <brief_title>Abdominal Binder Study to Decrease Postoperative Pain</brief_title>
  <official_title>A Controlled Randomized Trial Examining the Ability of the Mott Compression Bonder to Decrease Postoperative Pain in Gynecologic Abdominal Laparotomy Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brooke Army Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brooke Army Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We conducted a controlled randomized trial examining the ability of the Mott abdominal&#xD;
      Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy&#xD;
      patients&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2001</start_date>
  <completion_date type="Actual">February 2006</completion_date>
  <primary_completion_date type="Actual">February 2006</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pain</measure>
    <time_frame>24 hours</time_frame>
    <description>linear pain scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ambulations in 24 hours postoperatively</measure>
    <time_frame>24 hours</time_frame>
    <description>number ambulations</description>
  </secondary_outcome>
  <other_outcome>
    <measure>amount morphine used in 24 hours postoperatively</measure>
    <time_frame>24 hours</time_frame>
    <description>mg morphine</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>regular bandage</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>no abdominal binder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>abdominal binder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>binder</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>abdominal binder</intervention_name>
    <arm_group_label>abdominal binder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no binder</intervention_name>
    <arm_group_label>regular bandage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  gynecologic abdominal laparotomy patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non gynecologic abdominal laparotomy patients&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Brooke Army Medical Center</name>
      <address>
        <city>Ft Sam Houston</city>
        <state>Texas</state>
        <zip>78232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>September 13, 2012</last_update_submitted>
  <last_update_submitted_qc>September 13, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brooke Army Medical Center</investigator_affiliation>
    <investigator_full_name>Edward R. Kost, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>abdominal binder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT01685593
org study id: C.2001.128
nct id: NCT01685593
lead sponsor: 
has dmc: Yes
We conducted a controlled randomized trial examining the ability of the Mott abdominal
      Compression Binder to decrease postoperative pain in gynecologic abdominal laparotomy
      patients
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: postoperative pain
time frame: 24 hours
description: linear pain scale
measure: ambulations in 24 hours postoperatively
time frame: 24 hours
description: number ambulations
measure: amount morphine used in 24 hours postoperatively
time frame: 24 hours
description: mg morphine
arm group label: regular bandage
arm group type: Sham Comparator
description: no abdominal binder
arm group label: abdominal binder
arm group type: Experimental
description: binder
intervention type: Device
intervention name: abdominal binder
arm group label: abdominal binder
intervention type: Other
intervention name: no binder
arm group label: regular bandage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brooke Army Medical Center
investigator full name: Edward R. Kost, M.D.
investigator title: Principal Investigator
mesh term: Pain, Postoperative