<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/NCT03763279</url>
  </required_header>
  <id_info>
    <org_study_id>HRJC-HUSJ 18-10</org_study_id>
    <nct_id>NCT03763279</nct_id>
  </id_info>
  <brief_title>Effect of Barbed Suture and Triclosan-coated Monofilament in Emergency Surgery</brief_title>
  <official_title>Suture of the Abdominal Wall With Triclosan-coated Polydioxanone Barbed Suture vs Triclosan-coated Polydioxanone Monofilament vs Polydioxanone Monofilament in Emergency Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Elche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Elche</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>
      Patients will be randomized 3 groups:&#xD;
&#xD;
      Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed&#xD;
      Polydioxanone suture&#xD;
&#xD;
      Group 2:Abdominal fascial closure will be performed with Triclosan-coated monofilament&#xD;
      Polydioxanone suture&#xD;
&#xD;
      Group 3: Abdominal fascial closure will be performed with monofilament Polydioxanone suture&#xD;
&#xD;
      Incisional surgical.site infection and evisceration will be recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized 3 groups:&#xD;
&#xD;
      Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed&#xD;
      Polydioxanone suture (Stratafix Symmetric, J&amp;J), caliber 1, 48mm-cylindric needle.&#xD;
&#xD;
      Group 2:Abdominal fascial closure will be performed with Triclosan-coated Polydioxanone loop&#xD;
      suture (PDS plus looc, J&amp;J), caliber 1, 48mm-cylindric needle.&#xD;
&#xD;
      Group 3: Abdominal fascial closure will be performed with Polydioxanone loop suture (PDS plus&#xD;
      looc, J&amp;J), caliber 1, 48mm-cylindric needle.&#xD;
&#xD;
      Incisional surgical.site infection and evisceration will be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">March 31, 2019</primary_completion_date>
  <phase>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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The patient and the epidemiology nurse, who will assess the presence of SSI, will be blinded to the treatment assigned.&#xD;
The surgeon is masked to the assignment prior to consenting and enrolling the patient and initiating the surgery.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of incisional surgical-site infection</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Diagnosis of incisional surgical-site infection during the postoperative course</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of Evisceration</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Triclosan-coated barbed suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triclosan-coated monofilament suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Monofilament suture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Abdominal wall closure will be performed using a monofilament suture</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Triclosan-coated barbed suture</intervention_name>
    <description>Use of Triclosan-coated Polydioxanone barbed suture</description>
    <arm_group_label>Triclosan-coated barbed suture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Triclosan-coated monofilament suture</intervention_name>
    <description>Use of Triclosan-coated Polydioxanone monofilament suture</description>
    <arm_group_label>Triclosan-coated monofilament suture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Monofilament suture</intervention_name>
    <description>Use of Polydioxanone monofilament suture</description>
    <arm_group_label>Monofilament suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Contaminated and Dirty surgery&#xD;
&#xD;
          -  Emergency surgery performed by midline laparotomic approach&#xD;
&#xD;
          -  The following diagnosis will be included:&#xD;
&#xD;
               -  Anastomotic leak of previous digestive surgery (colon, small bowel or gastric&#xD;
                  surgery)&#xD;
&#xD;
               -  Colonic or bowel perforations&#xD;
&#xD;
               -  Appendicitis with purulent of fecal peritonitis, undergoing midline laparotomy&#xD;
&#xD;
               -  Perforation of gastric or duodenal ulcer&#xD;
&#xD;
               -  Intestinal ischemia requiring bowel resection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Emergency surgery undergoing laparoscopic approach&#xD;
&#xD;
          -  Appendicitis operated by McBurney incision&#xD;
&#xD;
          -  Intestinal isquemia without requiring bowel resection&#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>Andres Garcia-Marin</last_name>
    <role>Study Director</role>
    <affiliation>Hospital de San Juan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Hospital Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 30, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Elche</investigator_affiliation>
    <investigator_full_name>Jaime Ruiz-Tovar, MD, PhD</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Triclosan</mesh_term>
  </intervention_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/NCT03763279
org study id: HRJC-HUSJ 18-10
nct id: NCT03763279
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients will be randomized 3 groups:

      Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed
      Polydioxanone suture

      Group 2:Abdominal fascial closure will be performed with Triclosan-coated monofilament
      Polydioxanone suture

      Group 3: Abdominal fascial closure will be performed with monofilament Polydioxanone suture

      Incisional surgical.site infection and evisceration will be recorded.
Patients will be randomized 3 groups:

      Group 1: Abdominal fascial closure will be performed with Triclosan-coated barbed
      Polydioxanone suture (Stratafix Symmetric, J&J), caliber 1, 48mm-cylindric needle.

      Group 2:Abdominal fascial closure will be performed with Triclosan-coated Polydioxanone loop
      suture (PDS plus looc, J&J), caliber 1, 48mm-cylindric needle.

      Group 3: Abdominal fascial closure will be performed with Polydioxanone loop suture (PDS plus
      looc, J&J), caliber 1, 48mm-cylindric needle.

      Incisional surgical.site infection and evisceration will be recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: The patient and the epidemiology nurse, who will assess the presence of SSI, will be blinded to the treatment assigned.
The surgeon is masked to the assignment prior to consenting and enrolling the patient and initiating the surgery.
measure: Rate of incisional surgical-site infection
time frame: 30 days postoperatively
description: Diagnosis of incisional surgical-site infection during the postoperative course
measure: Rate of Evisceration
time frame: 30 days postoperatively
description: Diagnosis of evisceration during the postoperative course, which will be assessed by physical examination
arm group label: Triclosan-coated barbed suture
arm group type: Experimental
description: Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone barbed suture
arm group label: Triclosan-coated monofilament suture
arm group type: Experimental
description: Abdominal wall closure will be performed using a Triclosan-coated Polydioxanone monofilament suture
arm group label: Monofilament suture
arm group type: Sham Comparator
description: Abdominal wall closure will be performed using a monofilament suture
intervention type: Combination Product
intervention name: Triclosan-coated barbed suture
description: Use of Triclosan-coated Polydioxanone barbed suture
arm group label: Triclosan-coated barbed suture
intervention type: Combination Product
intervention name: Triclosan-coated monofilament suture
description: Use of Triclosan-coated Polydioxanone monofilament suture
arm group label: Triclosan-coated monofilament suture
intervention type: Device
intervention name: Monofilament suture
description: Use of Polydioxanone monofilament suture
arm group label: Monofilament suture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andres Garcia-Marin
role: Study Director
affiliation: Hospital de San Juan
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Elche
investigator full name: Jaime Ruiz-Tovar, MD, PhD
investigator title: Professor of Surgery
mesh term: Surgical Wound Infection
mesh term: Emergencies
mesh term: Triclosan