<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/NCT04458415</url>
  </required_header>
  <id_info>
    <org_study_id>2020-0361</org_study_id>
    <nct_id>NCT04458415</nct_id>
  </id_info>
  <brief_title>The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women</brief_title>
  <official_title>The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Geisinger Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinical Innovations</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Geisinger Clinic</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>
      This is an unblinded, randomized control trial of obese women to evaluate the impact of the&#xD;
      Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when&#xD;
      compared to silk tape.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to assess whether using the Traxi Panniculus Retractor during&#xD;
      cesarean section, in obese (BMI greater than or equal to 30kg/m2 at time of delivery) women,&#xD;
      can decrease the cesarean operative time compared to using silk tape to retract the&#xD;
      panniculus. Operative time is defined as the time from when the patient lies on the operating&#xD;
      room table (at completion of the epidural/spinal anesthesia) until fascial closure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Collaborator discontinued at this site to pursue the study with a different site.&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 1, 2021</start_date>
  <completion_date type="Anticipated">April 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2022</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No Masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time from when a subject lies on the OR table to fascial closure</measure>
    <time_frame>During surgery-Time from when a subject lies on the OR table to fascial closure</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time from skin incision to delivery</measure>
    <time_frame>During surgery-skin incision to delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from hysterotomy to delivery</measure>
    <time_frame>During surgery-hysterotomy to delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from skin incision to closure of fascia</measure>
    <time_frame>During surgery-skin incision to closure of fascia</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from skin incision to skin closure</measure>
    <time_frame>During surgery-skin incision to skin closure</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>TPR Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Silk Tape Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surgeon will use silk tape to retract the panniculus during cesarean section.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traxi Panniculus Retractor (TPR)</intervention_name>
    <description>Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.</description>
    <arm_group_label>TPR Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Silk Tape</intervention_name>
    <description>Surgeon uses silk tape to retract the panniculus during C-Section.</description>
    <arm_group_label>Silk Tape Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Current BMI equal to or greater than 30 kg/m2 at last prenatal visit or on day of&#xD;
             admission to L&amp;D&#xD;
&#xD;
          -  Requires panniculus retractor for cesarean delivery, as determined by the surgeon&#xD;
&#xD;
          -  Non-emergent cesarean delivery&#xD;
&#xD;
          -  Spinal or epidural anesthesia&#xD;
&#xD;
          -  Low transverse skin incision&#xD;
&#xD;
          -  Gestational age equal to or more than 32 weeks 0 days&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  Three or less previous cesarean deliveries.&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of Alexis or any other retractor&#xD;
&#xD;
          -  General anesthesia&#xD;
&#xD;
          -  Fetal demise&#xD;
&#xD;
          -  Placenta previa&#xD;
&#xD;
          -  History of bariatric surgery&#xD;
&#xD;
          -  Adhesive allergy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael J Paglia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Geisinger Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Geisinger Medical Center</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17821</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04458415
org study id: 2020-0361
nct id: NCT04458415
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is an unblinded, randomized control trial of obese women to evaluate the impact of the
      Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when
      compared to silk tape.
The purpose of the study is to assess whether using the Traxi Panniculus Retractor during
      cesarean section, in obese (BMI greater than or equal to 30kg/m2 at time of delivery) women,
      can decrease the cesarean operative time compared to using silk tape to retract the
      panniculus. Operative time is defined as the time from when the patient lies on the operating
      room table (at completion of the epidural/spinal anesthesia) until fascial closure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
masking description: No Masking
measure: Time from when a subject lies on the OR table to fascial closure
time frame: During surgery-Time from when a subject lies on the OR table to fascial closure
measure: Time from skin incision to delivery
time frame: During surgery-skin incision to delivery
measure: Time from hysterotomy to delivery
time frame: During surgery-hysterotomy to delivery
measure: Time from skin incision to closure of fascia
time frame: During surgery-skin incision to closure of fascia
measure: Time from skin incision to skin closure
time frame: During surgery-skin incision to skin closure
arm group label: TPR Arm
arm group type: Experimental
description: Surgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section.
arm group label: Silk Tape Arm
arm group type: Active Comparator
description: Surgeon will use silk tape to retract the panniculus during cesarean section.
intervention type: Other
intervention name: Traxi Panniculus Retractor (TPR)
description: Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.
arm group label: TPR Arm
intervention type: Other
intervention name: Silk Tape
description: Surgeon uses silk tape to retract the panniculus during C-Section.
arm group label: Silk Tape Arm
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Michael J Paglia, MD
role: Principal Investigator
affiliation: Geisinger Clinic
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No