<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/NCT04455321</url>
  </required_header>
  <id_info>
    <org_study_id>KA19/170</org_study_id>
    <nct_id>NCT04455321</nct_id>
  </id_info>
  <brief_title>The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study</brief_title>
  <official_title>The Effect of Suture Materials With Different Absorption Times on Isthmocele: Prospective Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baskent University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baskent University</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 study aims to investigate the effect of suture materials with different absorption times&#xD;
      on istmocel.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 15, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">August 1, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Rapid vicryl will used in study group and vicryl will used in control group for uterine closure in cesarean section.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Istmocel</measure>
    <time_frame>Six months</time_frame>
    <description>Istmocel area measurement with saline-infusion ultrasonography</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Suture, Complication</condition>
  <condition>Istmocel</condition>
  <arm_group>
    <arm_group_label>Vicryl</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Single layer locked uterine closure with vicryl suture material</description>
  </arm_group>
  <arm_group>
    <arm_group_label>rapide vicryl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single layer locked uterine closure with rapide vicryl suture material</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suture materials effect on istmocel</intervention_name>
    <description>Effect of suture materials with different absorption times on istmocel</description>
    <arm_group_label>Vicryl</arm_group_label>
    <arm_group_label>rapide vicryl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary cesarean section&#xD;
&#xD;
          -  single pregnancy&#xD;
&#xD;
          -  18-45 age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diabetes mellitus disease&#xD;
&#xD;
          -  inflammatory bowel disease&#xD;
&#xD;
          -  systemic lupus erythematosus disease&#xD;
&#xD;
          -  rheumatoid arthritis disease&#xD;
&#xD;
          -  previous uterine surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Baskent University Adana Dr. Turgut Noyan Hospital</name>
      <address>
        <city>Adana</city>
        <zip>01000</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>February 5, 2021</last_update_submitted>
  <last_update_submitted_qc>February 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baskent University</investigator_affiliation>
    <investigator_full_name>Selçuk Yetkinel</investigator_full_name>
    <investigator_title>MD.</investigator_title>
  </responsible_party>
  <keyword>rapid</keyword>
  <keyword>suture material</keyword>
  <keyword>istmocel</keyword>
  <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/NCT04455321
org study id: KA19/170
nct id: NCT04455321
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to investigate the effect of suture materials with different absorption times
      on istmocel.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Rapid vicryl will used in study group and vicryl will used in control group for uterine closure in cesarean section.
primary purpose: Prevention
masking: None (Open Label)
measure: Istmocel
time frame: Six months
description: Istmocel area measurement with saline-infusion ultrasonography
arm group label: Vicryl
arm group type: Active Comparator
description: Single layer locked uterine closure with vicryl suture material
arm group label: rapide vicryl
arm group type: Experimental
description: Single layer locked uterine closure with rapide vicryl suture material
intervention type: Procedure
intervention name: Suture materials effect on istmocel
description: Effect of suture materials with different absorption times on istmocel
arm group label: Vicryl
arm group label: rapide vicryl
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Baskent University
investigator full name: Selçuk Yetkinel
investigator title: MD.
sharing ipd: No