<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/NCT01691352</url>
  </required_header>
  <id_info>
    <org_study_id>Stoma Closure_Wound Infection</org_study_id>
    <nct_id>NCT01691352</nct_id>
  </id_info>
  <brief_title>Wick vs. No Wick: Does Method of Closure Affect Rate of Wound Infection?</brief_title>
  <official_title>Prospective, Randomized Controlled Trial of Wound Management After Ostomy Closure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Healthcare of Atlanta</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Healthcare of Atlanta</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Countless children undergo surgery annually for management of what clinicians consider to be&#xD;
      a &quot;dirty wound&quot;. One frequently encountered example is the ostomy reversal. During this&#xD;
      planned operation, the previously diverted small bowel or colon is reconnected with the&#xD;
      distal intestine, restoring continuity. However, this procedure leaves an open wound on the&#xD;
      anterior abdominal wall, creating a conundrum for the surgeon and raises the question: how&#xD;
      should the wound be managed? In the investigators practice at CHOA, surgeons utilize both a&#xD;
      wick and a non-wicked wound dressing. In this prospective randomized trial, we wish to&#xD;
      evaluate these two dressings in children receiving an ostomy closure. The investigators&#xD;
      hypothesis is that the incidence of wound infection after ostomy reversal is the same&#xD;
      regardless of if a wick is placed or not.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Countless children undergo surgery annually for management of what clinicians consider to be&#xD;
      a &quot;dirty wound&quot;. These include any case where the patient has a known intraabdominal&#xD;
      infection or enteric contents are likely to have contaminated the surgical field. One&#xD;
      frequently encountered example is the ostomy reversal. During this planned operation, the&#xD;
      previously diverted small bowel or colon is reconnected with the distal intestine, restoring&#xD;
      continuity. However, this procedure leaves an open wound on the anterior abdominal wall,&#xD;
      creating a conundrum for the surgeon and raises the question: how should the wound be&#xD;
      managed?&#xD;
&#xD;
      Historically, surgeons would close the ostomy site in a primary fashion using a running&#xD;
      subcuticular suture. While there is no &quot;national standard&quot; for wound closure of ostomies,&#xD;
      concern over the likelihood of local wound infection has led most modern day practitioners to&#xD;
      leave the wound open to drain in some fashion. Still the techniques used varies from the use&#xD;
      of simple interrupted sutures along the wound incision to the use of a betadine soaked gauze&#xD;
      &quot;wick&quot; in the wound. Other surgeons have attempted to close ostomy sites in a delayed&#xD;
      fashion, 48-72 hours after the primary operation.&#xD;
&#xD;
      Limited research has been prospectively performed to evaluate and compare the merit of these&#xD;
      techniques. In children, there has been no recent data directly addressing this question.&#xD;
&#xD;
      In our practice at CHOA, surgeons utilize both a wick and a non-wicked wound dressing. Our&#xD;
      current wound infection rate is approximately 10%, defined as spreading redness, draining&#xD;
      pus, fever, increased wound tenderness in the perioperative period. Unfortunately, the type&#xD;
      of dressing placed at the end of an operation is rarely, if ever documented in an operative&#xD;
      note, therefore a retrospective review to assess outcomes is not feasible. While there is no&#xD;
      exact statistics for how many ostomies were closed using a wick versus an non-wicked&#xD;
      dressing, in a survey of our 7 physicians, approximately 50% of the attending report that&#xD;
      they place a wick on all of their patients and the remaining attendings do not use a wick&#xD;
      with the rare exception of a particularly &quot;dirty wound&quot; (i.e. significant spillage of stool&#xD;
      into the wound or grossly necrotic/infected tissue) or a particularly deep wound. Clinicians&#xD;
      who elect to use a wick have adopted that practice based on person opinion that it allows the&#xD;
      wounds to drain better, thus preventing infection. Those who do not place a wick state that&#xD;
      they feel it is an unnecessary step in the dressing and that interrupted sutures alone are&#xD;
      sufficient to allow the wound to drain.&#xD;
&#xD;
      After a lengthy discussion with all of the surgeons at Egleston and 4 of the surgeons at&#xD;
      Scottish Rite, as a department, we have decided to evaluate the type of dressing used for&#xD;
      ostomy closure in order to see if there is in fact any benefit to leaving a wick in the&#xD;
      ostomy wound. All of the surgeons have agreed to participate in this study without undo bias.&#xD;
&#xD;
      In this prospective randomized trial, we wish to evaluate these two dressings in children&#xD;
      receiving an ostomy closure. Our hypothesis is that the incidence of wound infection after&#xD;
      ostomy reversal is the same regardless of if a wick is placed or not.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    lack of sufficient population for recruitment&#xD;
  </why_stopped>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound infection</measure>
    <time_frame>14 days</time_frame>
    <description>We will be evaluating wound infection rate, as determined by spreading redness, draining pus, fever, increased wound tenderness in the perioperative period.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Postoperative Wound Infection</condition>
  <arm_group>
    <arm_group_label>Wick</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with wick placed in their wound at the time of ostomy reversal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No wick</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>patients with non-wicked dressing placed on their wound</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Wick dressing</intervention_name>
    <description>Once the fascia of the ostomy site is closed, the subcutaneous space will be irrigated with normal saline. The skin will then be reapproximated using an absorbable suture, spaced every 1 cm across the wound (i.e. for a 2cm wound, a single suture will be placed in the middle). A moist, saline/betadine soaked gauze will then be gently packed into the wound spaces, on either side of the sutures. The gauze will be packed into the wound to the depth of ½ a cm, or ½ of the wound depth, whichever is greater. A single dry piece of gauze will then be secured over the top of the wound. Dressings and packing will be removed by the surgical team on post-operative day 2</description>
    <arm_group_label>Wick</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No Wick</intervention_name>
    <description>Once the fascia of the ostomy site is closed, the subcutaneous space will be irrigated with normal saline. The skin will then be reapproximated using an absorbable suture, spaced every 1 cm across the wound (i.e. for a 2 cm wound, a single suture will be placed in the middle). A single piece of dry gauze will then be secured over the top of the wound. Dressings will be removed by the surgical team on post-operative day 2</description>
    <arm_group_label>No wick</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients at Children's Healthcare of Atlanta (Egleston or Scotish Rite campus) who are&#xD;
        scheduled to undergo an ostomy reversal will be approached for participation in this study.&#xD;
        As there truly is no known &quot;better&quot; dressing for this type of wound, all patients,&#xD;
        including those with co-morbidities such as immunosuppression will be eligible for&#xD;
        inclusion in this study. Only those whose families consent to be included in the study will&#xD;
        be included or randomized to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who do not give consent to participate will be excluded from this study.&#xD;
        Additionally, if at the time of the operation, the surgeon feels that it is not in the&#xD;
        patient's best interest to be randomized and included in the study, he/she may decide to&#xD;
        exclude the patient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Clifton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty Surgeon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Healthcare of Atlanta at Egleston</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>December 16, 2014</last_update_submitted>
  <last_update_submitted_qc>December 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 17, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Wound infection</keyword>
  <keyword>Ostomy reversal</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT01691352
org study id: Stoma Closure_Wound Infection
nct id: NCT01691352
lead sponsor: 
has dmc: No
Countless children undergo surgery annually for management of what clinicians consider to be
      a "dirty wound". One frequently encountered example is the ostomy reversal. During this
      planned operation, the previously diverted small bowel or colon is reconnected with the
      distal intestine, restoring continuity. However, this procedure leaves an open wound on the
      anterior abdominal wall, creating a conundrum for the surgeon and raises the question: how
      should the wound be managed? In the investigators practice at CHOA, surgeons utilize both a
      wick and a non-wicked wound dressing. In this prospective randomized trial, we wish to
      evaluate these two dressings in children receiving an ostomy closure. The investigators
      hypothesis is that the incidence of wound infection after ostomy reversal is the same
      regardless of if a wick is placed or not.
Countless children undergo surgery annually for management of what clinicians consider to be
      a "dirty wound". These include any case where the patient has a known intraabdominal
      infection or enteric contents are likely to have contaminated the surgical field. One
      frequently encountered example is the ostomy reversal. During this planned operation, the
      previously diverted small bowel or colon is reconnected with the distal intestine, restoring
      continuity. However, this procedure leaves an open wound on the anterior abdominal wall,
      creating a conundrum for the surgeon and raises the question: how should the wound be
      managed?

      Historically, surgeons would close the ostomy site in a primary fashion using a running
      subcuticular suture. While there is no "national standard" for wound closure of ostomies,
      concern over the likelihood of local wound infection has led most modern day practitioners to
      leave the wound open to drain in some fashion. Still the techniques used varies from the use
      of simple interrupted sutures along the wound incision to the use of a betadine soaked gauze
      "wick" in the wound. Other surgeons have attempted to close ostomy sites in a delayed
      fashion, 48-72 hours after the primary operation.

      Limited research has been prospectively performed to evaluate and compare the merit of these
      techniques. In children, there has been no recent data directly addressing this question.

      In our practice at CHOA, surgeons utilize both a wick and a non-wicked wound dressing. Our
      current wound infection rate is approximately 10%, defined as spreading redness, draining
      pus, fever, increased wound tenderness in the perioperative period. Unfortunately, the type
      of dressing placed at the end of an operation is rarely, if ever documented in an operative
      note, therefore a retrospective review to assess outcomes is not feasible. While there is no
      exact statistics for how many ostomies were closed using a wick versus an non-wicked
      dressing, in a survey of our 7 physicians, approximately 50% of the attending report that
      they place a wick on all of their patients and the remaining attendings do not use a wick
      with the rare exception of a particularly "dirty wound" (i.e. significant spillage of stool
      into the wound or grossly necrotic/infected tissue) or a particularly deep wound. Clinicians
      who elect to use a wick have adopted that practice based on person opinion that it allows the
      wounds to drain better, thus preventing infection. Those who do not place a wick state that
      they feel it is an unnecessary step in the dressing and that interrupted sutures alone are
      sufficient to allow the wound to drain.

      After a lengthy discussion with all of the surgeons at Egleston and 4 of the surgeons at
      Scottish Rite, as a department, we have decided to evaluate the type of dressing used for
      ostomy closure in order to see if there is in fact any benefit to leaving a wick in the
      ostomy wound. All of the surgeons have agreed to participate in this study without undo bias.

      In this prospective randomized trial, we wish to evaluate these two dressings in children
      receiving an ostomy closure. Our hypothesis is that the incidence of wound infection after
      ostomy reversal is the same regardless of if a wick is placed or not.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Wound infection
time frame: 14 days
description: We will be evaluating wound infection rate, as determined by spreading redness, draining pus, fever, increased wound tenderness in the perioperative period.
arm group label: Wick
arm group type: Active Comparator
description: Patients with wick placed in their wound at the time of ostomy reversal
arm group label: No wick
arm group type: Sham Comparator
description: patients with non-wicked dressing placed on their wound
intervention type: Procedure
intervention name: Wick dressing
description: Once the fascia of the ostomy site is closed, the subcutaneous space will be irrigated with normal saline. The skin will then be reapproximated using an absorbable suture, spaced every 1 cm across the wound (i.e. for a 2cm wound, a single suture will be placed in the middle). A moist, saline/betadine soaked gauze will then be gently packed into the wound spaces, on either side of the sutures. The gauze will be packed into the wound to the depth of ½ a cm, or ½ of the wound depth, whichever is greater. A single dry piece of gauze will then be secured over the top of the wound. Dressings and packing will be removed by the surgical team on post-operative day 2
arm group label: Wick
intervention type: Procedure
intervention name: No Wick
description: Once the fascia of the ostomy site is closed, the subcutaneous space will be irrigated with normal saline. The skin will then be reapproximated using an absorbable suture, spaced every 1 cm across the wound (i.e. for a 2 cm wound, a single suture will be placed in the middle). A single piece of dry gauze will then be secured over the top of the wound. Dressings will be removed by the surgical team on post-operative day 2
arm group label: No wick
criteria: 
gender: All
minimum age: 1 Day
maximum age: 18 Years
healthy volunteers: No
last name: Matthew Clifton, MD
role: Principal Investigator
affiliation: Faculty Surgeon
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Wounds and Injuries