<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/NCT04503642</url>
  </required_header>
  <id_info>
    <org_study_id>CLOT-T trial</org_study_id>
    <nct_id>NCT04503642</nct_id>
  </id_info>
  <brief_title>Changing the Surgical Team for Wound Closure and Surgical Site Infection</brief_title>
  <official_title>Impact of Changing the Surgical Team for Wound Closure on Surgical Site Infection: a Matched Case-control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      Surgical site infection is a frequent complication after abdominal surgery. The wound closure&#xD;
      is done at the end of the procedure when the attention of the entire team may be affected&#xD;
      because of tiredness and reduced attention of the surgical team.&#xD;
&#xD;
      With this study, the investigators aim to test if an exchange of the surgical team by a&#xD;
      specialised wound closure team may reduce the impact of surgical site infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients with SSIs</measure>
    <time_frame>30 days postoperative</time_frame>
    <description>SSI that occur after surgery will be assessed according to the criteria developed by the Centers for Disease Control and Prevention. Infections will be categorized as incisional (superficial or deep) infections or organ-space infections. Superficial SSI (type 1) involve only skin and subcutaneous tissue and exclude stitch abscesses. Deep SSI (type 2) involve deeper soft tissues, like fascia and muscle, at the site of incision. Organ-space SSI (type 3) involve any organ or body cavity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days postoperative</time_frame>
    <description>Postoperative Mortality at 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of patients with fascial dehiscence at 30 days postoperative</measure>
    <time_frame>30 days postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of patients with complications</measure>
    <time_frame>30 days postoperative</time_frame>
    <description>Assessment according to Clavien-Dindo grading</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1160</enrollment>
  <condition>Incidence of Surgical Site Infection</condition>
  <condition>Morality</condition>
  <condition>Fascial Hernia</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <description>The intervention consisted in the closure of the abdominal wall and skin by a second surgical team which included a board-certified surgeon and a resident.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Baseline Group</arm_group_label>
    <description>During the baseline period, closure of the abdominal wall was performed by the main surgical team, the same team that performed the whole surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Changing the surgical team for wound closure</intervention_name>
    <description>The intervention consists of the exchange of the primary surgical team with a second surgical team that consists of one surgeon and one student. The first surgical team then may leave the operation theatre but is continuously accessible for questions.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Department of Visceral Surgery of the University Hospital Bern, a tertiary care centre&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General Consent as documented by signature&#xD;
&#xD;
          -  Patients undergoing elective or emergency abdominal surgery from Monday to Friday with&#xD;
             wound closure from 8:00 until 17:30 and duration of operation.&#xD;
&#xD;
          -  Age over 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients &lt; 18 years of age&#xD;
&#xD;
          -  Patients with preexisting SSI&#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>Guido Beldi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Visceral and transplant sugery, university hospital Berne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dep. of Visceral and transplant surgery, Berne University Hospital</name>
      <address>
        <city>Berne</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 3, 2020</last_update_submitted>
  <last_update_submitted_qc>August 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surgical Site Infection</keyword>
  <keyword>Changing the surgical team</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/NCT04503642
org study id: CLOT-T trial
nct id: NCT04503642
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Surgical site infection is a frequent complication after abdominal surgery. The wound closure
      is done at the end of the procedure when the attention of the entire team may be affected
      because of tiredness and reduced attention of the surgical team.

      With this study, the investigators aim to test if an exchange of the surgical team by a
      specialised wound closure team may reduce the impact of surgical site infection.
observational model: Case-Control
time perspective: Prospective
measure: Number of patients with SSIs
time frame: 30 days postoperative
description: SSI that occur after surgery will be assessed according to the criteria developed by the Centers for Disease Control and Prevention. Infections will be categorized as incisional (superficial or deep) infections or organ-space infections. Superficial SSI (type 1) involve only skin and subcutaneous tissue and exclude stitch abscesses. Deep SSI (type 2) involve deeper soft tissues, like fascia and muscle, at the site of incision. Organ-space SSI (type 3) involve any organ or body cavity
measure: Mortality
time frame: 30 days postoperative
description: Postoperative Mortality at 30 days
measure: Numbers of patients with fascial dehiscence at 30 days postoperative
time frame: 30 days postoperative
measure: Numbers of patients with complications
time frame: 30 days postoperative
description: Assessment according to Clavien-Dindo grading
arm group label: Intervention Group
description: The intervention consisted in the closure of the abdominal wall and skin by a second surgical team which included a board-certified surgeon and a resident.
arm group label: Baseline Group
description: During the baseline period, closure of the abdominal wall was performed by the main surgical team, the same team that performed the whole surgery.
intervention type: Procedure
intervention name: Changing the surgical team for wound closure
description: The intervention consists of the exchange of the primary surgical team with a second surgical team that consists of one surgeon and one student. The first surgical team then may leave the operation theatre but is continuously accessible for questions.
arm group label: Intervention Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Guido Beldi, MD
role: Principal Investigator
affiliation: Visceral and transplant sugery, university hospital Berne
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection