<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/NCT03801421</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AFCRC2017SJ-007-2</org_study_id>
    <nct_id>NCT03801421</nct_id>
  </id_info>
  <brief_title>Mass Continous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision</brief_title>
  <official_title>Mass Continuous Suture With PDS Versus Interrupted Suture With Thread on Major Abdominal Incision: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital Xi'an Jiaotong 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>
      A better suture technology will reduce postoperative incision complications. This study is&#xD;
      designed to compare mass continous suture with PDS and interrupted suture with thread on&#xD;
      major abdominal incision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A better suture technology will reduce postoperative incision complications. The previous&#xD;
      retrospective cohort study from the investigator has demonstrated that continuous mass suture&#xD;
      with PDS led to shorter incision closure time, early wound healing and comparable incisional&#xD;
      complications versus interrupted thread suture. As such, the current RCT study will include&#xD;
      100 subjects with major abdominal incision. They will be divided into two groups randomly:&#xD;
      Mass suture gorup, mass continuous suture with PDS, Control group, interrupted suture with&#xD;
      thread. The wound healing time, stitches removal time and incidence of incision complications&#xD;
      will be compared between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">March 16, 2021</completion_date>
  <primary_completion_date type="Actual">March 16, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>healing time, d (day)</measure>
    <time_frame>Up to 1 month after surgery</time_frame>
    <description>Time duration between the date of surgery to the date of stitches off</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of incision complications</measure>
    <time_frame>Up to 1 month after surgery</time_frame>
    <description>The incision complications include infection, dehiscence, fat liquefaction, and so on.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2000</enrollment>
  <condition>Surgical Wound</condition>
  <condition>Suture, Complication</condition>
  <arm_group>
    <arm_group_label>Continous suture group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The surgical incision will be treated by mass continous suture with PDS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The surgical incision will be treated by interrupted suture with thread.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mass continous suture with PDS</intervention_name>
    <description>The surgical incision will be treated by mass continous suture with PDS.</description>
    <arm_group_label>Continous suture group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Interrupted suture with thread</intervention_name>
    <description>The surgical incision will be treated by interrupted suture with thread.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the patient with major abdominal incision.&#xD;
&#xD;
          -  the incision is longer than 10 cm&#xD;
&#xD;
          -  aged between 18 to 65 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman&#xD;
&#xD;
          -  Patient with diabetes&#xD;
&#xD;
          -  Patient with a history of cardiovascular disease, including coronary heart disease and&#xD;
             stroke.&#xD;
&#xD;
          -  Severe lung diseases such as COPD and asthma&#xD;
&#xD;
          -  Patients undergoing emergent or infectious surgery&#xD;
&#xD;
          -  Patients with surgical site infection&#xD;
&#xD;
          -  No autonomy, inability or unwillingness to participate in follow-up&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xu-Feng Zhang, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital Xi'an Jiaotong University</investigator_affiliation>
    <investigator_full_name>Zhang Xu-Feng</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Surgical Wound</keyword>
  <keyword>Suture, Complication</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</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/NCT03801421
org study id: XJTU1AFCRC2017SJ-007-2
nct id: NCT03801421
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A better suture technology will reduce postoperative incision complications. This study is
      designed to compare mass continous suture with PDS and interrupted suture with thread on
      major abdominal incision.
A better suture technology will reduce postoperative incision complications. The previous
      retrospective cohort study from the investigator has demonstrated that continuous mass suture
      with PDS led to shorter incision closure time, early wound healing and comparable incisional
      complications versus interrupted thread suture. As such, the current RCT study will include
      100 subjects with major abdominal incision. They will be divided into two groups randomly:
      Mass suture gorup, mass continuous suture with PDS, Control group, interrupted suture with
      thread. The wound healing time, stitches removal time and incidence of incision complications
      will be compared between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: healing time, d (day)
time frame: Up to 1 month after surgery
description: Time duration between the date of surgery to the date of stitches off
measure: incidence of incision complications
time frame: Up to 1 month after surgery
description: The incision complications include infection, dehiscence, fat liquefaction, and so on.
arm group label: Continous suture group
arm group type: Experimental
description: The surgical incision will be treated by mass continous suture with PDS.
arm group label: Control group
arm group type: Active Comparator
description: The surgical incision will be treated by interrupted suture with thread.
intervention type: Procedure
intervention name: Mass continous suture with PDS
description: The surgical incision will be treated by mass continous suture with PDS.
arm group label: Continous suture group
intervention type: Procedure
intervention name: Interrupted suture with thread
description: The surgical incision will be treated by interrupted suture with thread.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Xu-Feng Zhang, MD, PhD
role: Principal Investigator
affiliation: First Affiliated Hospital Xi'an Jiaotong University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital Xi'an Jiaotong University
investigator full name: Zhang Xu-Feng
investigator title: Professor
mesh term: Surgical Wound