<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/NCT03798041</url>
  </required_header>
  <id_info>
    <org_study_id>XJTU1AFCRC2017SJ-007-1</org_study_id>
    <nct_id>NCT03798041</nct_id>
  </id_info>
  <brief_title>Early Debridement Within 24 Hours After Surgery for Wound Healing of Abdominal Incision</brief_title>
  <official_title>Early Debridement Within 24 Hours After Surgery Compared Routine Debridement (24 Hours Later) for Wound Healing of Abdominal Incision</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>
      Wound healing after surgery is a complex procedure. Liquefaction of the fat and necrosis of&#xD;
      inactivated tissue, as well as blood clots are always accumulated mostly within 24 hours&#xD;
      after surgery. As such, early debridement within 24 hours after surgery might improve the&#xD;
      healing of the wounds. This study is designed to compare the impact of early debridement of&#xD;
      the wound versus regular dressing (24 hours later) on the wound healing. 100 patients will be&#xD;
      included in this study, and divided into 2 groups randomly. Then, the healing of the wound,&#xD;
      stitch removal time, incidence of incision complications will be compared between the two&#xD;
      groups.&#xD;
    </textblock>
  </brief_summary>
  <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>From date of surgery to the date of stitches off (up to 1 month)</time_frame>
    <description>since the ending of surgery to stitches off.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of incision complications</measure>
    <time_frame>From the date of surgery to stitches off (up to 1 month)</time_frame>
    <description>The incision complications include infection, dehiscence, fat liquefaction, etc.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">480</enrollment>
  <condition>Surgical Wound</condition>
  <arm_group>
    <arm_group_label>Debridement group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The subjects in this group will be debrided within 24 hours after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The subjects in this group will experience wound dressing change regularly 24 hours after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Debridement Within 24 Hours After Surgery</intervention_name>
    <description>Debrided within 24 hours after surgery</description>
    <arm_group_label>Debridement group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the patient with major abdominal incision.&#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 surgery or infectious surgery&#xD;
&#xD;
          -  Patients with surgical site infection or abdominal abscess&#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>March 2021</verification_date>
  <study_first_submitted>January 1, 2019</study_first_submitted>
  <study_first_submitted_qc>January 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03798041
org study id: XJTU1AFCRC2017SJ-007-1
nct id: NCT03798041
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Wound healing after surgery is a complex procedure. Liquefaction of the fat and necrosis of
      inactivated tissue, as well as blood clots are always accumulated mostly within 24 hours
      after surgery. As such, early debridement within 24 hours after surgery might improve the
      healing of the wounds. This study is designed to compare the impact of early debridement of
      the wound versus regular dressing (24 hours later) on the wound healing. 100 patients will be
      included in this study, and divided into 2 groups randomly. Then, the healing of the wound,
      stitch removal time, 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: From date of surgery to the date of stitches off (up to 1 month)
description: since the ending of surgery to stitches off.
measure: incidence of incision complications
time frame: From the date of surgery to stitches off (up to 1 month)
description: The incision complications include infection, dehiscence, fat liquefaction, etc.
arm group label: Debridement group
arm group type: Experimental
description: The subjects in this group will be debrided within 24 hours after surgery.
arm group label: Control group
arm group type: No Intervention
description: The subjects in this group will experience wound dressing change regularly 24 hours after surgery.
intervention type: Behavioral
intervention name: Debridement Within 24 Hours After Surgery
description: Debrided within 24 hours after surgery
arm group label: Debridement 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: Sponsor
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: No