xml: <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/NCT05963477</url>
    </required_header>
    <id_info>
      <org_study_id>40-FMIC-ER-18</org_study_id>
      <nct_id>NCT05963477</nct_id>
    </id_info>
    <brief_title>Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions: A Prospective Cohort Study</brief_title>
    <official_title>Pediatric Post-operative Abdominal Wound Dehiscence in Association With Midline vs Other Incisions in Tertiary Care Setting Kabul Afghanistan: A Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>French Medical Institute for Mothers and Children</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>French Medical Institute for Mothers and Children</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 is designed to see different abdominal incisions complication among neonates,&#xD;
        infants and children and to find risk factors for developing wound dehiscence&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2018</start_date>
    <completion_date type="Actual">June 30, 2020</completion_date>
    <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Wound dehiscence or burst abdomen</measure>
      <time_frame>one month after intervention</time_frame>
      <description>the overall outcome of the intervention (incisions) is wound dehiscence in different age groups, in gender, among who has or has no risk factors and among different wound class</description>
    </primary_outcome>
    <number_of_groups>6</number_of_groups>
    <enrollment type="Actual">270</enrollment>
    <condition>Wound Dehiscence</condition>
    <condition>Incision</condition>
    <arm_group>
      <arm_group_label>Age Group</arm_group_label>
      <description>Neonates Infants Children</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Gender</arm_group_label>
      <description>Male Female</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Selective/Emergency</arm_group_label>
      <description>Selective Emergency</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Wound Class</arm_group_label>
      <description>Clean Clean-contaminated Contaminated Infected</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Risk Factors</arm_group_label>
      <description>Yes No</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Type of Incisions</arm_group_label>
      <description>Midline Trransverse Oblique</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>laparatomy</intervention_name>
      <description>all abdominal procedures which are approached by different incisions</description>
      <arm_group_label>Age Group</arm_group_label>
      <arm_group_label>Gender</arm_group_label>
      <arm_group_label>Risk Factors</arm_group_label>
      <arm_group_label>Selective/Emergency</arm_group_label>
      <arm_group_label>Type of Incisions</arm_group_label>
      <arm_group_label>Wound Class</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          all patients from neonatal age until 18 years old who were planned to undergo abdominal&#xD;
          surgery.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          -all abdominal surgeries patient under 18-year-old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Umbilical hernia, redo laparatomy, laparoscopic surgery.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>French Medical Institute for Mothers and Children</name>
        <address>
          <city>Kabul</city>
          <zip>1006</zip>
          <country>Afghanistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Afghanistan</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>French Medical Institute for Mothers and Children</investigator_affiliation>
      <investigator_full_name>Abdullah Bahloli</investigator_full_name>
      <investigator_title>Dr. Abdullah Bahloli</investigator_title>
    </responsible_party>
    <keyword>abdominal wound dehiscence, burst abdomen, pediatric abdominal incisions, children</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Surgical Wound</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>November 17, 2018</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT05963477/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963477
  org study id: 40-FMIC-ER-18
  nct id: NCT05963477
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is designed to see different abdominal incisions complication among neonates,
        infants and children and to find risk factors for developing wound dehiscence
  observational model: Cohort
  time perspective: Prospective
  measure: Wound dehiscence or burst abdomen
  time frame: one month after intervention
  description: the overall outcome of the intervention (incisions) is wound dehiscence in different age groups, in gender, among who has or has no risk factors and among different wound class
  arm group label: Age Group
  description: Neonates Infants Children
  arm group label: Gender
  description: Male Female
  arm group label: Selective/Emergency
  description: Selective Emergency
  arm group label: Wound Class
  description: Clean Clean-contaminated Contaminated Infected
  arm group label: Risk Factors
  description: Yes No
  arm group label: Type of Incisions
  description: Midline Trransverse Oblique
  intervention type: Procedure
  intervention name: laparatomy
  description: all abdominal procedures which are approached by different incisions
  arm group label: Age Group
  arm group label: Gender
  arm group label: Risk Factors
  arm group label: Selective/Emergency
  arm group label: Type of Incisions
  arm group label: Wound Class
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: 18 Years
  healthy volunteers: No
  facility: 
  country: Afghanistan
  responsible party type: Principal Investigator
  investigator affiliation: French Medical Institute for Mothers and Children
  investigator full name: Abdullah Bahloli
  investigator title: Dr. Abdullah Bahloli
  mesh term: Wounds and Injuries
  mesh term: Surgical Wound
  sharing ipd: No
  provided document: 