<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/NCT03273777</url>
  </required_header>
  <id_info>
    <org_study_id>1641_2016</org_study_id>
    <nct_id>NCT03273777</nct_id>
  </id_info>
  <brief_title>Skin Incision Skewness at Cesarean Section</brief_title>
  <official_title>Comparison of Skin Incision Skewness With or Without Previous Measurement and Drawing of the Incision Line at Cesarean Section - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</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>
      Skin incision skewness, incision length on both sides of the midline and patient's perception&#xD;
      of the scar after cesarean section will be compared between the following two groups: (1)&#xD;
      Drawing of an incision line prior to skin incision and (2) no drawing of an incision line.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Some aspects of the surgical techniques employed during cesarean section have already been&#xD;
      evaluated in regards to possible improvements of cosmetic outcome, such as the use of&#xD;
      different skin closure materials or whether subcutaneous fat suture closure leads to better&#xD;
      results than non-closure. Another point to be considered is the skewness of the scar. Many&#xD;
      surgeons make the skin incision based on their experience without prior measurement and&#xD;
      drawing of an incision line. However, following a predefined incision line may reduce the&#xD;
      rate of skew incisions. Therefore, this study aims to compare these two approaches to the&#xD;
      skin incision.&#xD;
&#xD;
      Participating women will be recruited at the Department of Obstetrics and Gynecology of the&#xD;
      Medical University of Vienna. They will be included into the study after written informed&#xD;
      consent and will be randomized into one of the two groups (drawing of an incision line prior&#xD;
      to skin incision versus no drawing of an incision line) on the day of cesarean section.&#xD;
&#xD;
      Skewness of the skin incision in each group will be assessed after cesarean section.&#xD;
      Furthermore, it will be determined whether there are any differences in the incision length&#xD;
      on both sides of an imaginary line from the umbilicus to the clitoris between these two&#xD;
      techniques. Additionally, patient's perception of the scar before discharge from hospital&#xD;
      will be assessed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skin incision skewness</measure>
    <time_frame>10 minutes (from a photograph taken at the end of the operation)</time_frame>
    <description>Skewness of the incision will be assessed using digital photos and an appropriate software.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incision length on both sides of the midline</measure>
    <time_frame>2 minutes (1 minute for measurement at the end of the operation and 1 minute postoperatively from a photo taken at the end of the operation)</time_frame>
    <description>The length will be measured in cm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's perception of the scar</measure>
    <time_frame>1 minute (before discharge from hospital)</time_frame>
    <description>Skewness and length of the scar are rated by the patient.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">86</enrollment>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>Drawing of an incision line</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An incision line of 14 cm will be drawn using a conventional surgical ruler and pen before skin incision.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No drawing of an incision line</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Skin incision will be carried out without previous drawing of an incision line.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Drawing of an incision line</intervention_name>
    <description>Drawing of an incision line prior to skin incision at cesarean section</description>
    <arm_group_label>Drawing of an incision line</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  First cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Performance of an acute cesarean section&#xD;
&#xD;
          -  Previous cesarean section&#xD;
&#xD;
          -  Body mass index &gt; 35 kg/m²&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Heinrich Husslein</last_name>
    <phone>0043140400</phone>
    <phone_ext>28210</phone_ext>
    <email>heinrich.husslein@meduniwien.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heinrich Husslein</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Heinrich Husslein</investigator_full_name>
    <investigator_title>Ass.-Prof.</investigator_title>
  </responsible_party>
  <keyword>Cesarean section</keyword>
  <keyword>Skin incision</keyword>
  <keyword>Skewness</keyword>
  <keyword>Line drawing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</mesh_term>
  </condition_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/NCT03273777
org study id: 1641_2016
nct id: NCT03273777
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Skin incision skewness, incision length on both sides of the midline and patient's perception
      of the scar after cesarean section will be compared between the following two groups: (1)
      Drawing of an incision line prior to skin incision and (2) no drawing of an incision line.
Some aspects of the surgical techniques employed during cesarean section have already been
      evaluated in regards to possible improvements of cosmetic outcome, such as the use of
      different skin closure materials or whether subcutaneous fat suture closure leads to better
      results than non-closure. Another point to be considered is the skewness of the scar. Many
      surgeons make the skin incision based on their experience without prior measurement and
      drawing of an incision line. However, following a predefined incision line may reduce the
      rate of skew incisions. Therefore, this study aims to compare these two approaches to the
      skin incision.

      Participating women will be recruited at the Department of Obstetrics and Gynecology of the
      Medical University of Vienna. They will be included into the study after written informed
      consent and will be randomized into one of the two groups (drawing of an incision line prior
      to skin incision versus no drawing of an incision line) on the day of cesarean section.

      Skewness of the skin incision in each group will be assessed after cesarean section.
      Furthermore, it will be determined whether there are any differences in the incision length
      on both sides of an imaginary line from the umbilicus to the clitoris between these two
      techniques. Additionally, patient's perception of the scar before discharge from hospital
      will be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Skin incision skewness
time frame: 10 minutes (from a photograph taken at the end of the operation)
description: Skewness of the incision will be assessed using digital photos and an appropriate software.
measure: Incision length on both sides of the midline
time frame: 2 minutes (1 minute for measurement at the end of the operation and 1 minute postoperatively from a photo taken at the end of the operation)
description: The length will be measured in cm.
measure: Patient's perception of the scar
time frame: 1 minute (before discharge from hospital)
description: Skewness and length of the scar are rated by the patient.
arm group label: Drawing of an incision line
arm group type: Experimental
description: An incision line of 14 cm will be drawn using a conventional surgical ruler and pen before skin incision.
arm group label: No drawing of an incision line
arm group type: No Intervention
description: Skin incision will be carried out without previous drawing of an incision line.
intervention type: Procedure
intervention name: Drawing of an incision line
description: Drawing of an incision line prior to skin incision at cesarean section
arm group label: Drawing of an incision line
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Heinrich Husslein
phone: 0043140400
phone ext: 28210
email: heinrich.husslein@meduniwien.ac.at
facility: 
status: Recruiting
contact: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Heinrich Husslein
investigator title: Ass.-Prof.
mesh term: Surgical Wound
sharing ipd: No