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/NCT05989386</url>
    </required_header>
    <id_info>
      <org_study_id>2811</org_study_id>
      <nct_id>NCT05989386</nct_id>
    </id_info>
    <brief_title>Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of IOWI in Preventing SSIs in Emergency Laparotomies</brief_title>
    <official_title>Outcomes of High-volume Saline Irrigation VS Povidone-Iodine Solution Cleaning of Intraoperative Incision Wound in Preventing Surgical Site Infections in Emergency Laparotomies: A Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dow University of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dow University of Health Sciences</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>
        The goal of this clinical trial is to compare the outcomes of High-volume saline irrigation&#xD;
        vs Povidone-iodine solution cleaning of the intraoperative incision wound in preventing&#xD;
        superficial surgical site infections in patients undergoing emergency laparotomies. The main&#xD;
        question it aims to answer are:&#xD;
  &#xD;
          -  Incidence of SSI after intervention&#xD;
  &#xD;
          -  Length of hospital stay&#xD;
  &#xD;
        Participants will be randomly assigned to two groups receiving either of the two groups:&#xD;
  &#xD;
        Group A: 1000ml of IOWI with saline solution prior to incision closure Group B: The&#xD;
        incisional wound will be closed conventionally without irrigation.&#xD;
  &#xD;
        Researchers will compare groups A( experimental group) and B (control group) to compare the&#xD;
        incidence of superficial surgical site infections after intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 29, 2023</start_date>
    <completion_date type="Anticipated">May 29, 2024</completion_date>
    <primary_completion_date type="Anticipated">April 29, 2024</primary_completion_date>
    <phase>Phase 2/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>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Superficial Surgical site infections</measure>
      <time_frame>Upto 4 weeks post-operatively</time_frame>
      <description>Development of Superficial Surgical Site Infection as determined by the CDC guidelines.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Length of Hospital Stay</measure>
      <time_frame>Upto 4 weeks post-operatively</time_frame>
      <description>Number of in-hospital days (from time of admission to time of discharge)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Surgical Site Infection</condition>
    <condition>Surgical Wound</condition>
    <condition>Surgical Incision</condition>
    <condition>Emergency Laparotomies</condition>
    <condition>Laparotomies</condition>
    <condition>Post Operative Wound Infection</condition>
    <condition>Wound Infection</condition>
    <condition>Seroma</condition>
    <arm_group>
      <arm_group_label>Group A</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intra-operative wound irrigation of 0.9% solution saline solution</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>No intra-operative wound lavage done</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>0.9% saline solution</intervention_name>
      <description>During emergency laparotomy, after the primary surgical procedure. the sheath will be sutured and the incision site will then be irrigated with three rounds of 1 liter of 0.9% saline solution, which will be completely aspirated before the closure of the incisional wound in experimental group.</description>
      <arm_group_label>Group A</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Povidone-iodine Swab</intervention_name>
      <description>No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab.</description>
      <arm_group_label>Group B</arm_group_label>
      <other_name>Control</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  • Patients undergoing emergency laparotomy under the care of surgical-6 unit of Dr.&#xD;
               Ruth K. M. Pfau Civil Hospital Karachi&#xD;
  &#xD;
                 -  The age of patients should be between 18-60 years old.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diabetic patients&#xD;
  &#xD;
            -  Immune-suppressed patients&#xD;
  &#xD;
            -  Patients taking steroids&#xD;
  &#xD;
            -  Patients undergoing chemo-radiotherapy.&#xD;
  &#xD;
            -  Pregnant females&#xD;
  &#xD;
            -  Previous abdominal surgery within the last 30 days.&#xD;
  &#xD;
            -  Presence of concurrent abdominal wall infections.&#xD;
  &#xD;
            -  Trauma Laparotomies&#xD;
  &#xD;
            -  Large Bowel perforations&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Omer Bin Khalid, Assist Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dr. Ruth F. M. Pfau Civil Hospital Karachi</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Imrana Zulfikar, Professor</last_name>
      <role>Study Director</role>
      <affiliation>Dr. Ruth F. M. Pfau Civil Hospital Karachi</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Omer Bin Khalid, Assist Prof.</last_name>
      <phone>+92 321 2040064</phone>
      <email>dromerkhalid@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Afeera Ahmed, Undergraduate</last_name>
      <phone>+923352547330</phone>
      <email>afeeranws@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Dr. Ruth K. M. Pfau Civil Hospital Karachi</name>
        <address>
          <city>Karachi</city>
          <state>Sindh</state>
          <zip>74400</zip>
          <country>Pakistan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Omer Bin khalid, Asst. Prof</last_name>
        <phone>+92 321 2040064</phone>
        <email>dromerkhalid@gmail.com</email>
      </contact>
      <investigator>
        <last_name>Omer Bin Khalid, FCPS-II</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Afeera Bashir, Undergrad.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Azzam Ali, Undergrad.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Bushra Saeed Khan, FCPS-I</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Rabbiyya Ali, FCPS-II</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Imrana Zulfikar, FCPS-II</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dow University of Health Sciences</investigator_affiliation>
      <investigator_full_name>Omer bin khalid</investigator_full_name>
      <investigator_title>Principal Investigator (Assistant Professor)</investigator_title>
    </responsible_party>
    <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>
      <mesh_term>Wound Infection</mesh_term>
      <mesh_term>Emergencies</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
      <mesh_term>Surgical Wound</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Povidone-Iodine</mesh_term>
      <mesh_term>Povidone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05989386
  org study id: 2811
  nct id: NCT05989386
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the outcomes of High-volume saline irrigation
        vs Povidone-iodine solution cleaning of the intraoperative incision wound in preventing
        superficial surgical site infections in patients undergoing emergency laparotomies. The main
        question it aims to answer are:
  
          -  Incidence of SSI after intervention
  
          -  Length of hospital stay
  
        Participants will be randomly assigned to two groups receiving either of the two groups:
  
        Group A: 1000ml of IOWI with saline solution prior to incision closure Group B: The
        incisional wound will be closed conventionally without irrigation.
  
        Researchers will compare groups A( experimental group) and B (control group) to compare the
        incidence of superficial surgical site infections after intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Outcomes Assessor)
  measure: Incidence of Superficial Surgical site infections
  time frame: Upto 4 weeks post-operatively
  description: Development of Superficial Surgical Site Infection as determined by the CDC guidelines.
  measure: Length of Hospital Stay
  time frame: Upto 4 weeks post-operatively
  description: Number of in-hospital days (from time of admission to time of discharge)
  arm group label: Group A
  arm group type: Experimental
  description: Intra-operative wound irrigation of 0.9% solution saline solution
  arm group label: Group B
  arm group type: Active Comparator
  description: No intra-operative wound lavage done
  intervention type: Procedure
  intervention name: 0.9% saline solution
  description: During emergency laparotomy, after the primary surgical procedure. the sheath will be sutured and the incision site will then be irrigated with three rounds of 1 liter of 0.9% saline solution, which will be completely aspirated before the closure of the incisional wound in experimental group.
  arm group label: Group A
  intervention type: Procedure
  intervention name: Povidone-iodine Swab
  description: No intra-operative wound lavage done, and wound would be cleaned with povidone doused swab.
  arm group label: Group B
  other name: Control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: No
  last name: Omer Bin Khalid, Assist Prof.
  role: Principal Investigator
  affiliation: Dr. Ruth F. M. Pfau Civil Hospital Karachi
  last name: Imrana Zulfikar, Professor
  role: Study Director
  affiliation: Dr. Ruth F. M. Pfau Civil Hospital Karachi
  last name: Omer Bin Khalid, Assist Prof.
  phone: +92 321 2040064
  email: dromerkhalid@gmail.com
  last name: Afeera Ahmed, Undergraduate
  phone: +923352547330
  email: afeeranws@gmail.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Pakistan
  responsible party type: Principal Investigator
  investigator affiliation: Dow University of Health Sciences
  investigator full name: Omer bin khalid
  investigator title: Principal Investigator (Assistant Professor)
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Surgical Wound Infection
  mesh term: Wound Infection
  mesh term: Emergencies
  mesh term: Wounds and Injuries
  mesh term: Surgical Wound
  mesh term: Povidone-Iodine
  mesh term: Povidone
  sharing ipd: No