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/NCT06014788</url>
    </required_header>
    <id_info>
      <org_study_id>20.08.1964</org_study_id>
      <nct_id>NCT06014788</nct_id>
    </id_info>
    <brief_title>Is the NPWTi Better Than the Conventional NPWT</brief_title>
    <official_title>NPWTi vs. Conventional NPWT in Superficial and Deep Abdominal Surgical Site Infections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Military Medical Academy</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Military Medical Academy</source>
    <oversight_info>
      <has_dmc>Yes</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 effectiveness of NPWTi and NPWT in&#xD;
        superficial and deep surgical site infections using an improvised system with continuous&#xD;
        lavage with saline and chlorhexidine. The main question it aims to answer is whether the&#xD;
        NPWTi is better than conventional NPWT. Participants will be given NPWTi or conventional&#xD;
        NPWT.&#xD;
  &#xD;
        Researchers will compare the two groups to see if NPWTi diminishes the rate of recurrent&#xD;
        infections and the number of reoperations, shortens the hospital stay, and alleviates the&#xD;
        burden on the hospital staff in comparison to the conventional NPWT.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 17, 2018</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>eradication of the infection</measure>
      <time_frame>6 weeks</time_frame>
      <description>(negative microbiology or bacterial count &lt; 103)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>the rate of wound closure</measure>
      <time_frame>6 weeks</time_frame>
      <description>the wound closure by suture or flap</description>
    </primary_outcome>
    <primary_outcome>
      <measure>30-day recurrence rate</measure>
      <time_frame>30 days after discharge</time_frame>
      <description>30-day recurrence rate of the infection</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>hospital stay</measure>
      <time_frame>6 weeks</time_frame>
      <description>hospital stay in days</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of OR visits</measure>
      <time_frame>6 weeks</time_frame>
      <description>number of OR visits and dressing changes under general anesthesia</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time to wound closure</measure>
      <time_frame>6 weeks</time_frame>
      <description>the time elapsed from the start of the treatment to wound closure</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Postoperative Wound Infection Superficial Incisional</condition>
    <condition>Postoperative Wound Infection Deep Incisional Surgical Site</condition>
    <arm_group>
      <arm_group_label>NPWTi</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The whole wound was filled with black foam (Granufoam®, KCI). The instillation was performed via gravity from i.v. bag through a drain put within the foam. Chlorhexidine 0.1% 300 ml in 700 ml saline was used for continuous instillation three times daily (3 L per day) on the background of continuous pressure of 125 mmHg. The dressing changes were performed every 48-72 hours.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>conventional NPWT</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The wound was filled with black foam (Granufoam®, KCI) and covered with plastic folio. A continuous pressure of 125 mmHg was applied using the hospital suction system. The dressing changes were performed every 48 hours.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>NPWTi</intervention_name>
      <description>The wound was filled with black foam (Granufoam®, KCI). The instillation was performed via gravity from i.v. bag through a drain put within the foam. Chlorhexidine 0.1% 300 ml in 700 ml saline was used for continuous instillation three times daily (3 L per day) on the background of continuous pressure of 125 mmHg.</description>
      <arm_group_label>NPWTi</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Conventional NPWT</intervention_name>
      <description>Conventional NPWT</description>
      <arm_group_label>conventional NPWT</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  adults over 18 years&#xD;
  &#xD;
            -  superficial or deep SSIs after laparotomy or laparoscopic surgery&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  persons &lt; 18 years&#xD;
  &#xD;
            -  documented inherited or acquired coagulation disorders or platelet deficiency&#xD;
  &#xD;
            -  presence of deep space infection (intra-abdominal abscess or ongoing peritonitis)&#xD;
  &#xD;
            -  prosthetic material infection&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ventsislav Mutafchiyski, DSc, FACS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Military Medical Academy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Georgi Popivanov</last_name>
      <phone>+354885521241</phone>
      <email>gerasimpopivanov@rocketmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Sugery</name>
        <address>
          <city>Sofia</city>
          <zip>1606</zip>
          <country>Bulgaria</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Georgi Popivanov, PhD</last_name>
        <phone>+354885521241</phone>
        <email>gerasimpopivanov@rocketmail.com</email>
      </contact>
      <contact_backup>
        <last_name>Kirien Kjossev, PhD</last_name>
        <email>kirienkt@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Ventsislav Mutafchiyski, DSc, FACS</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Kirien Kjossev, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dimitar Penchev, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Daniel Stefanov, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Bulgaria</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>NPWTi</keyword>
    <keyword>conventional NPWT</keyword>
    <keyword>superficial and deep SSIs</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>Wound Infection</mesh_term>
      <mesh_term>Surgical Wound Infection</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_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/NCT06014788
  org study id: 20.08.1964
  nct id: NCT06014788
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare the effectiveness of NPWTi and NPWT in
        superficial and deep surgical site infections using an improvised system with continuous
        lavage with saline and chlorhexidine. The main question it aims to answer is whether the
        NPWTi is better than conventional NPWT. Participants will be given NPWTi or conventional
        NPWT.
  
        Researchers will compare the two groups to see if NPWTi diminishes the rate of recurrent
        infections and the number of reoperations, shortens the hospital stay, and alleviates the
        burden on the hospital staff in comparison to the conventional NPWT.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  measure: eradication of the infection
  time frame: 6 weeks
  description: (negative microbiology or bacterial count < 103)
  measure: the rate of wound closure
  time frame: 6 weeks
  description: the wound closure by suture or flap
  measure: 30-day recurrence rate
  time frame: 30 days after discharge
  description: 30-day recurrence rate of the infection
  measure: hospital stay
  time frame: 6 weeks
  description: hospital stay in days
  measure: number of OR visits
  time frame: 6 weeks
  description: number of OR visits and dressing changes under general anesthesia
  measure: time to wound closure
  time frame: 6 weeks
  description: the time elapsed from the start of the treatment to wound closure
  arm group label: NPWTi
  arm group type: Experimental
  description: The whole wound was filled with black foam (Granufoam®, KCI). The instillation was performed via gravity from i.v. bag through a drain put within the foam. Chlorhexidine 0.1% 300 ml in 700 ml saline was used for continuous instillation three times daily (3 L per day) on the background of continuous pressure of 125 mmHg. The dressing changes were performed every 48-72 hours.
  arm group label: conventional NPWT
  arm group type: Active Comparator
  description: The wound was filled with black foam (Granufoam®, KCI) and covered with plastic folio. A continuous pressure of 125 mmHg was applied using the hospital suction system. The dressing changes were performed every 48 hours.
  intervention type: Device
  intervention name: NPWTi
  description: The wound was filled with black foam (Granufoam®, KCI). The instillation was performed via gravity from i.v. bag through a drain put within the foam. Chlorhexidine 0.1% 300 ml in 700 ml saline was used for continuous instillation three times daily (3 L per day) on the background of continuous pressure of 125 mmHg.
  arm group label: NPWTi
  intervention type: Device
  intervention name: Conventional NPWT
  description: Conventional NPWT
  arm group label: conventional NPWT
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Ventsislav Mutafchiyski, DSc, FACS
  role: Principal Investigator
  affiliation: Military Medical Academy
  last name: Georgi Popivanov
  phone: +354885521241
  email: gerasimpopivanov@rocketmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Bulgaria
  responsible party type: Sponsor
  mesh term: Infections
  mesh term: Communicable Diseases
  mesh term: Wound Infection
  mesh term: Surgical Wound Infection
  mesh term: Wounds and Injuries
  sharing ipd: No