<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/NCT01713751</url>
  </required_header>
  <id_info>
    <org_study_id>ASUOGRCT03-2012</org_study_id>
    <nct_id>NCT01713751</nct_id>
  </id_info>
  <brief_title>Surgical Site Infection Rates in Obese Patients After Cesarean Delivery</brief_title>
  <official_title>Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determine the surgical site infection rate and patient&#xD;
      satisfaction for subcuticular versus interrupted mattress suture in closure of skin at&#xD;
      Cesarean delivery in obese patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled trial conducted in Ain-Shams University Maternity Hospital on&#xD;
      the period from March 2012 till August 2012. It included 130 pregnant women who underwent&#xD;
      elective Cesarean section.&#xD;
&#xD;
      The aim of this study is to determine the surgical site infection rate and patient&#xD;
      satisfaction for subcuticular versus interrupted mattress suture in closure of skin at&#xD;
      Cesarean delivery in obese patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical site infection</measure>
    <time_frame>30 days after the operative procedure</time_frame>
    <description>We used the definition devised and adopted by the Center for Disease Control and Prevention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Skin closure time</measure>
    <time_frame>15 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>48 hours</time_frame>
    <description>Measured by 10-cm visual analogue scale, zero being no pain and ten the worst possible pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-term cosmetic wound outcome</measure>
    <time_frame>30 days</time_frame>
    <description>We used Stony Brook Scar Evaluation Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall women satisfaction</measure>
    <time_frame>30 days</time_frame>
    <description>A questionnaire is used to check the patient satisfaction (satisfied versus unsatisfied) regarding the wound appearance and wound related pain</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">500</enrollment>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Interrupted suturing Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Subcuticular suturing Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene [Prolene®].</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Interrupted suturing</intervention_name>
    <description>Skin is closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]</description>
    <arm_group_label>Interrupted suturing Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Subcuticular suturing</intervention_name>
    <description>Skin is closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]</description>
    <arm_group_label>Subcuticular suturing Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: any female in childbearing period.&#xD;
&#xD;
          -  Women planned for elective Cesarean section.&#xD;
&#xD;
          -  Obese women (BMI ≥ 30 Kg/m2). Our study calculated the BMI of patients from their&#xD;
             weight and height at admission, because the pre-pregnancy BMI was not available for&#xD;
             all patients, and we hypothesized that the BMI at admission was a better indicator of&#xD;
             body mass during the at-risk time for development of SSI than was the pre-pregnancy&#xD;
             BMI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who had concurrent overt infection (e.g.chorioamnionitis, pyelonephritis or&#xD;
             chest infection).&#xD;
&#xD;
          -  Women who had intraoperative events that may themselves predispose to perioperative&#xD;
             infection (e.g. bowel injury, operative time more than 90 minutes, major blood loss).&#xD;
&#xD;
          -  Women who had hemoglobin less than 10g/dl, preeclampsia, diabetes, rupture of&#xD;
             membranes more than 12 hours, corticosteroid therapy.&#xD;
&#xD;
          -  Patients who had non Pfannenstiel incision.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Moustafa I. Ibrahim, MD</last_name>
    <role>Study Director</role>
    <affiliation>Assistant Professor of Obstetrics &amp; Gynecology Faculty of Medicine, Ain Shams University</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 14, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>October 24, 2012</last_update_submitted>
  <last_update_submitted_qc>October 24, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 25, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Mohamed Ellaithy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Surgical site infection</keyword>
  <keyword>Cesarean section</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical Wound Infection</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/NCT01713751
org study id: ASUOGRCT03-2012
nct id: NCT01713751
lead sponsor: 
has dmc: Yes
The aim of this study is to determine the surgical site infection rate and patient
      satisfaction for subcuticular versus interrupted mattress suture in closure of skin at
      Cesarean delivery in obese patients.
This is a randomized controlled trial conducted in Ain-Shams University Maternity Hospital on
      the period from March 2012 till August 2012. It included 130 pregnant women who underwent
      elective Cesarean section.

      The aim of this study is to determine the surgical site infection rate and patient
      satisfaction for subcuticular versus interrupted mattress suture in closure of skin at
      Cesarean delivery in obese patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Surgical site infection
time frame: 30 days after the operative procedure
description: We used the definition devised and adopted by the Center for Disease Control and Prevention.
measure: Skin closure time
time frame: 15 minutes
measure: Postoperative pain
time frame: 48 hours
description: Measured by 10-cm visual analogue scale, zero being no pain and ten the worst possible pain
measure: Short-term cosmetic wound outcome
time frame: 30 days
description: We used Stony Brook Scar Evaluation Scale
measure: Overall women satisfaction
time frame: 30 days
description: A questionnaire is used to check the patient satisfaction (satisfied versus unsatisfied) regarding the wound appearance and wound related pain
arm group label: Interrupted suturing Group
arm group type: Active Comparator
description: Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]
arm group label: Subcuticular suturing Group
arm group type: Active Comparator
description: Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene [Prolene®].
intervention type: Other
intervention name: Interrupted suturing
description: Skin is closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]
arm group label: Interrupted suturing Group
intervention type: Other
intervention name: Subcuticular suturing
description: Skin is closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]
arm group label: Subcuticular suturing Group
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 45 Years
healthy volunteers: No
last name: Moustafa I. Ibrahim, MD
role: Study Director
affiliation: Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Mohamed Ellaithy
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection