<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/NCT01713452</url>
  </required_header>
  <id_info>
    <org_study_id>0806M37362</org_study_id>
    <nct_id>NCT01713452</nct_id>
  </id_info>
  <brief_title>A Randomized Trial of Ostomy Closure Techniques</brief_title>
  <official_title>A Randomized Trial of Ostomy Closure Techniques: An Outcomes Evaluation of Primary Closure Versus Pursestring Closure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate&#xD;
      for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than&#xD;
      expected for a clean-contaminated operative classification. The ideal stoma site closure&#xD;
      technique is still debated in the current literature. The aim of this study was to compare&#xD;
      the rate of SSI following two different stoma closure techniques, primary closure versus a&#xD;
      skin approximating purse string closure, in a multi-center randomized controlled trial. The&#xD;
      investigators hypothesize that purse string closure technique will have a lower rate of SSI&#xD;
      than primary closure technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will randomize ileostomy takedown patients to either a primary closure or&#xD;
      purse string closure technique intraoperatively. Surgeons at both the University of Minnesota&#xD;
      and the CHUV hospital in Switzerland will participate in the this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2008</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>surgical site infection</measure>
    <time_frame>30 days postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>delayed wound healing</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Evidence of delayed wound-healing at stoma takedown site</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient satisfaction</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>We are measuring subject satisfaction with wound healing and cosmetic outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">125</enrollment>
  <condition>Wound Infection</condition>
  <arm_group>
    <arm_group_label>Purse string closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergo a purse string closure of their old stoma site.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Primary closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients have their stoma sites close primarily with staples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Purse string closure</intervention_name>
    <description>An incision around the stoma will be made with 2-3 mm circumferential margins. This dissection along the mucocutaneous junction will then be made to the fascial defect. Re-establishment of bowel continuity will them be performed. If the circumferential incision does not provide adequate exposure, the incision can be converted to an elliptical one. Thereafter, it will be closed primarily with staples, similar to the primary closure group.&#xD;
Following ostomy closure, the subcutaneous tissues will be irrigated. A 2-0 monocryl subcuticular purse string stitch will then be placed and cinched to a 1cm diameter. This opening will then be packed with Nu-Gauze as a wick dressing.&#xD;
Diameter of the skin defect should then be measured.&#xD;
A postoperative photo will then be taken.</description>
    <arm_group_label>Purse string closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Primary closure</intervention_name>
    <description>An elliptical incision (extending transversely) will be made with 2-3 mm superior/inferior margins around the mucocutaneous junction. Dissection will then be made in a perpendicular fashion through the subcutaneous tissue with tapering near the fascial defect. Re-establishment of bowel continuity will then be performed.&#xD;
Following ostomy closure, the subcutaneous tissue will be irrigated and the skin will be closed tight with staples placed at close intervals (&lt;1.5cm). No subcutaneous drains will be placed.&#xD;
Length of the incision should be measured in centimeters.&#xD;
A postoperative photo will then be taken.</description>
    <arm_group_label>Primary closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Subjects eligible are those with either a colostomy or ileostomy (end or loop) who are&#xD;
        deemed by their surgeon to be appropriate candidates for ostomy closure. There will be no&#xD;
        limitations based upon initial indication for formation of the ostomy. Indications for&#xD;
        initial ostomy formation for fecal diversion can include: infection (e.g. diverticulitis)&#xD;
        and protection of an anastomosis. (following resection for inflammatory bowel disease,&#xD;
        benign diseases, or cancer)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded from the study if:&#xD;
&#xD;
          1. The stoma site is left open to heal by secondary intention due to gross contamination&#xD;
             (surgeon discretion)&#xD;
&#xD;
          2. The stoma site is re-used (i.e. the same stoma site used for the formation of a new&#xD;
             ostomy)&#xD;
&#xD;
          3. A new stoma is created at a different site.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <last_update_submitted>October 30, 2019</last_update_submitted>
  <last_update_submitted_qc>October 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surgical Stomas</keyword>
  <keyword>ileostomy</keyword>
  <keyword>surgical site infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT01713452
org study id: 0806M37362
nct id: NCT01713452
lead sponsor: 
collaborator: 
has dmc: No
Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate
      for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than
      expected for a clean-contaminated operative classification. The ideal stoma site closure
      technique is still debated in the current literature. The aim of this study was to compare
      the rate of SSI following two different stoma closure techniques, primary closure versus a
      skin approximating purse string closure, in a multi-center randomized controlled trial. The
      investigators hypothesize that purse string closure technique will have a lower rate of SSI
      than primary closure technique.
The investigators will randomize ileostomy takedown patients to either a primary closure or
      purse string closure technique intraoperatively. Surgeons at both the University of Minnesota
      and the CHUV hospital in Switzerland will participate in the this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: surgical site infection
time frame: 30 days postoperatively
measure: delayed wound healing
time frame: 30 days postoperatively
description: Evidence of delayed wound-healing at stoma takedown site
measure: patient satisfaction
time frame: 30 days postoperatively
description: We are measuring subject satisfaction with wound healing and cosmetic outcome
arm group label: Purse string closure
arm group type: Active Comparator
description: Patients undergo a purse string closure of their old stoma site.
arm group label: Primary closure
arm group type: Active Comparator
description: Patients have their stoma sites close primarily with staples.
intervention type: Procedure
intervention name: Purse string closure
description: An incision around the stoma will be made with 2-3 mm circumferential margins. This dissection along the mucocutaneous junction will then be made to the fascial defect. Re-establishment of bowel continuity will them be performed. If the circumferential incision does not provide adequate exposure, the incision can be converted to an elliptical one. Thereafter, it will be closed primarily with staples, similar to the primary closure group.
Following ostomy closure, the subcutaneous tissues will be irrigated. A 2-0 monocryl subcuticular purse string stitch will then be placed and cinched to a 1cm diameter. This opening will then be packed with Nu-Gauze as a wick dressing.
Diameter of the skin defect should then be measured.
A postoperative photo will then be taken.
arm group label: Purse string closure
intervention type: Procedure
intervention name: Primary closure
description: An elliptical incision (extending transversely) will be made with 2-3 mm superior/inferior margins around the mucocutaneous junction. Dissection will then be made in a perpendicular fashion through the subcutaneous tissue with tapering near the fascial defect. Re-establishment of bowel continuity will then be performed.
Following ostomy closure, the subcutaneous tissue will be irrigated and the skin will be closed tight with staples placed at close intervals (<1.5cm). No subcutaneous drains will be placed.
Length of the incision should be measured in centimeters.
A postoperative photo will then be taken.
arm group label: Primary closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wound Infection