<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/NCT03780530</url>
  </required_header>
  <id_info>
    <org_study_id>Ain shams maternity U</org_study_id>
    <nct_id>NCT03780530</nct_id>
  </id_info>
  <brief_title>Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair</brief_title>
  <official_title>Comparison of Different Techniques for Perineal Skin Closure During Mediolateral Episiotomy Repair</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      this study aims to assess the efficacy and the safety of various cosmetic techniques&#xD;
      (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral&#xD;
      episiotomy repair&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2019</primary_completion_date>
  <phase>Phase 3</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short -term postpartum pain</measure>
    <time_frame>six hours postpartum</time_frame>
    <description>Post-operative perineal pain will be evaluated at 6 hrs after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean &quot;no pain&quot; and 10 would mean &quot;worst possible pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short -term postpartum pain</measure>
    <time_frame>10 days postnatal</time_frame>
    <description>Post-operative perineal pain will be evaluated at 10 days after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean &quot;no pain&quot; and 10 would mean &quot;worst possible pain</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">207</enrollment>
  <condition>Episiotomy</condition>
  <arm_group>
    <arm_group_label>subcuticular suturing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>surgical glue</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>adhesive steri-strip tape</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>subcuticular suturing</intervention_name>
    <description>Those undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®).</description>
    <arm_group_label>subcuticular suturing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical glue</intervention_name>
    <description>Those undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®).</description>
    <arm_group_label>surgical glue</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>adhesive steri-strip tape</intervention_name>
    <description>Those undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transpore™ Surgical Tapes).</description>
    <arm_group_label>adhesive steri-strip tape</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged above 18 yrs.&#xD;
&#xD;
          -  Primiparous.&#xD;
&#xD;
          -  Undergoing spontaneous vaginal delivery of a single full-term fetus.&#xD;
&#xD;
          -  Vertex presentation.&#xD;
&#xD;
          -  Having mediolateral episiotomy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Body mass index ≥ 35 kg/m2&#xD;
&#xD;
          -  Complicated delivery by any tears other than episiotomy or postpartum hemorrhage.&#xD;
&#xD;
          -  Any risk factor causing increased stretch of the perineum; Operative vaginal delivery,&#xD;
             fetal macrosomia.&#xD;
&#xD;
          -  The use of epidural anesthesia.&#xD;
&#xD;
          -  Previous perineal surgeries, local infection or lesions.&#xD;
&#xD;
          -  Any medical condition that can cause excessive bleeding or impair wound healing;&#xD;
             (cardiovascular disease, diabetes, anemia, coagulopathy, collagen disease or&#xD;
             Immunosuppression).&#xD;
&#xD;
          -  Contraindication or Hypersensitivity to any of materials used in the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 16, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Radwa Rasheedy Ali</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <!-- 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/NCT03780530
org study id: Ain shams maternity U
nct id: NCT03780530
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
this study aims to assess the efficacy and the safety of various cosmetic techniques
      (subcuticular, surgical glue, adhesive tapes) for perineal skin closure during mediolateral
      episiotomy repair
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Short -term postpartum pain
time frame: six hours postpartum
description: Post-operative perineal pain will be evaluated at 6 hrs after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain
measure: Short -term postpartum pain
time frame: 10 days postnatal
description: Post-operative perineal pain will be evaluated at 10 days after the procedure using visual analogue scale patient to choose a number from 0 to 10 that best describes their current pain. 0 would mean "no pain" and 10 would mean "worst possible pain
arm group label: subcuticular suturing
arm group type: Active Comparator
arm group label: surgical glue
arm group type: Active Comparator
arm group label: adhesive steri-strip tape
arm group type: Active Comparator
intervention type: Procedure
intervention name: subcuticular suturing
description: Those undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®).
arm group label: subcuticular suturing
intervention type: Procedure
intervention name: Surgical glue
description: Those undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®).
arm group label: surgical glue
intervention type: Procedure
intervention name: adhesive steri-strip tape
description: Those undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transpore™ Surgical Tapes).
arm group label: adhesive steri-strip tape
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Radwa Rasheedy Ali
investigator title: Principal Investigator