<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/NCT03773224</url>
  </required_header>
  <id_info>
    <org_study_id>mansoura67</org_study_id>
    <nct_id>NCT03773224</nct_id>
  </id_info>
  <brief_title>Role of Wound Irrigation After Appendectomy</brief_title>
  <official_title>A Randomized Trial on Wound Irrigation in Prevention of Surgical Site Infection After Appendectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura 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>
      Surgical site infection is a common problem after open appendectomy. Irrigation of the&#xD;
      surgical wound by topical antibiotics has been devised as a measure to reduce the incidence&#xD;
      of wound infection. The present trial aims to assess the efficacy of layer-by-layer wound&#xD;
      irrigation with gentamicin-saline solution in prevention of superficial surgical site&#xD;
      infection after open appendectomy for acute uncomplicated appendicitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">September 27, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical site infection</measure>
    <time_frame>2 months after surgery</time_frame>
    <description>The incidence of superficial site infection as detected by clinical examination on follow-up</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">179</enrollment>
  <condition>Appendicitis</condition>
  <arm_group>
    <arm_group_label>Irrigation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Layer by layer irrigation of the surgical wound with gentamicin-saline solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The surgical wound is closed layer by layer without irrigation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Irrigation</intervention_name>
    <description>upon closure of the peritoneum gentamicin-saline solution (160 mg of gentamicin in 400 ml of normal saline 0.9%) will be used for irrigation of every layer of the wound before its closure</description>
    <arm_group_label>Irrigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients of both genders aging between 18 and 65 years who present with acute&#xD;
             appendicitis.&#xD;
&#xD;
          -  Patients with perforated appendicitis will be also included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with appendicular mass, appendicular abscess, generalized peritonitis.&#xD;
&#xD;
          -  Patients with other causes of acute abdomen as revealed intraoperatively.&#xD;
&#xD;
          -  Patients taking long course of steroid therapy or immunosuppressive treatment,&#xD;
&#xD;
          -  Patients unwilling to participate in the trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sameh H Emile</last_name>
    <role>Study Chair</role>
    <affiliation>Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura university hospital</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>May 24, 2020</last_update_submitted>
  <last_update_submitted_qc>May 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Sameh Emile</investigator_full_name>
    <investigator_title>Lecturer of general surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03773224
org study id: mansoura67
nct id: NCT03773224
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgical site infection is a common problem after open appendectomy. Irrigation of the
      surgical wound by topical antibiotics has been devised as a measure to reduce the incidence
      of wound infection. The present trial aims to assess the efficacy of layer-by-layer wound
      irrigation with gentamicin-saline solution in prevention of superficial surgical site
      infection after open appendectomy for acute uncomplicated appendicitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Surgical site infection
time frame: 2 months after surgery
description: The incidence of superficial site infection as detected by clinical examination on follow-up
arm group label: Irrigation
arm group type: Active Comparator
description: Layer by layer irrigation of the surgical wound with gentamicin-saline solution
arm group label: Control
arm group type: No Intervention
description: The surgical wound is closed layer by layer without irrigation
intervention type: Procedure
intervention name: Irrigation
description: upon closure of the peritoneum gentamicin-saline solution (160 mg of gentamicin in 400 ml of normal saline 0.9%) will be used for irrigation of every layer of the wound before its closure
arm group label: Irrigation
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sameh H Emile
role: Study Chair
affiliation: Mansoura University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Mansoura University
investigator full name: Sameh Emile
investigator title: Lecturer of general surgery
mesh term: Appendicitis
sharing ipd: Undecided