<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/NCT03000010</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00064814</org_study_id>
    <nct_id>NCT03000010</nct_id>
  </id_info>
  <brief_title>Wound Vac Bandage Comparison After Spinal Fusion</brief_title>
  <acronym>WV</acronym>
  <official_title>Incisional Vacuum-assisted Closure Therapy After Posterior Spinal Fusion for Pediatric Neuromuscular Scoliosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted&#xD;
      closure (VAC) therapy in the prevention of infection after posterior spinal fusion for&#xD;
      pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized controlled study: Patients undergoing posterior spinal fusion will&#xD;
      be randomized to a standard postoperative dressing versus an incisional VAC dressing. Both&#xD;
      groups will have hematocrit, total lymphocyte count, and albumin checked preoperatively to&#xD;
      assess nutritional status, drawn at the same time as standard preoperative labs during&#xD;
      history and physical visit. Both groups will undergo standard wound closure and dressing&#xD;
      application before breaking the sterile field. The incisional VAC group will undergo&#xD;
      placement of an Adaptic dressing over the incision. A standard VAC sponge will be placed and&#xD;
      secured with adhesive dressing, and a suction tube will be connected to a VAC machine set to&#xD;
      75 mmHg of continuous suction. The incisional VAC will be left in place for 72 hours&#xD;
      postoperatively. Remainder of postoperative care will follow our standard posterior spinal&#xD;
      fusion protocol and will be identical in both groups. Patients will be followed for a minimum&#xD;
      of 2 years postoperatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2012</start_date>
  <completion_date type="Actual">July 17, 2020</completion_date>
  <primary_completion_date type="Actual">July 17, 2020</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>Number of Participants With Wound Dehiscence or Infection</measure>
    <time_frame>2 years</time_frame>
    <description>Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Neuromuscular Scoliosis</condition>
  <arm_group>
    <arm_group_label>Incisional Wound Vac</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal Gauze Bandage Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Incisional Wound Vac</intervention_name>
    <arm_group_label>Incisional Wound Vac</arm_group_label>
    <other_name>Incisional vacuum-assisted closure therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Bandage</intervention_name>
    <arm_group_label>Normal Gauze Bandage Group</arm_group_label>
    <other_name>Gauze Bandage</other_name>
    <other_name>Gauze</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  any patient 17 years and younger&#xD;
&#xD;
          -  neuromuscular scoliosis undergoing posterior spinal fusion&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  idiopathic and congenital scoliosis&#xD;
&#xD;
          -  any type of spine surgery other than posterior spinal fusion (eg. vertical expandable&#xD;
             prosthetic titanium rib placement, growing rod placement, anterior spinal fusion)&#xD;
&#xD;
          -  intraoperative dural tear&#xD;
&#xD;
          -  documented allergy to adhesive dressings&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ying G Li, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <results_first_submitted>June 5, 2021</results_first_submitted>
  <results_first_submitted_qc>June 5, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 28, 2021</results_first_posted>
  <last_update_submitted>June 5, 2021</last_update_submitted>
  <last_update_submitted_qc>June 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>G Ying Li</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Wound Vac</keyword>
  <keyword>Neuromuscular Scoliosis</keyword>
  <keyword>Posterior Spinal Fusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scoliosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT03000010/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Incisional Wound Vac</title>
          <description>We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery.&#xD;
Incisional Wound Vac</description>
        </group>
        <group group_id="P2">
          <title>Normal Gauze Bandage Group</title>
          <description>We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours.&#xD;
Standard Bandage</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Incisional Wound Vac</title>
          <description>We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery.&#xD;
Incisional Wound Vac</description>
        </group>
        <group group_id="B2">
          <title>Normal Gauze Bandage Group</title>
          <description>We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours.&#xD;
Standard Bandage</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="21"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.5" spread="1.6"/>
                    <measurement group_id="B2" value="12.6" spread="2.7"/>
                    <measurement group_id="B3" value="13" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="21"/>
                    <count group_id="B2" value="20"/>
                    <count group_id="B3" value="41"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Wound Dehiscence or Infection</title>
        <description>Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery</description>
        <time_frame>2 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Incisional Wound Vac</title>
            <description>We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery.&#xD;
Incisional Wound Vac</description>
          </group>
          <group group_id="O2">
            <title>Normal Gauze Bandage Group</title>
            <description>We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours.&#xD;
Standard Bandage</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Wound Dehiscence or Infection</title>
          <description>Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events data was not collected.</time_frame>
      <desc>While adverse events data was not collected, the study team discovered deaths at the time of follow-up interactions with participants' parents.</desc>
      <group_list>
        <group group_id="E1">
          <title>Incisional Wound Vac</title>
          <description>We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery.&#xD;
Incisional Wound Vac</description>
        </group>
        <group group_id="E2">
          <title>Normal Gauze Bandage Group</title>
          <description>We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours.&#xD;
Standard Bandage</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>G. Ying Li</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-936-5715</phone>
      <email>yingyuli@med.umich.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03000010
org study id: HUM00064814
nct id: NCT03000010
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted
      closure (VAC) therapy in the prevention of infection after posterior spinal fusion for
      pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.
A prospective randomized controlled study: Patients undergoing posterior spinal fusion will
      be randomized to a standard postoperative dressing versus an incisional VAC dressing. Both
      groups will have hematocrit, total lymphocyte count, and albumin checked preoperatively to
      assess nutritional status, drawn at the same time as standard preoperative labs during
      history and physical visit. Both groups will undergo standard wound closure and dressing
      application before breaking the sterile field. The incisional VAC group will undergo
      placement of an Adaptic dressing over the incision. A standard VAC sponge will be placed and
      secured with adhesive dressing, and a suction tube will be connected to a VAC machine set to
      75 mmHg of continuous suction. The incisional VAC will be left in place for 72 hours
      postoperatively. Remainder of postoperative care will follow our standard posterior spinal
      fusion protocol and will be identical in both groups. Patients will be followed for a minimum
      of 2 years postoperatively.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Wound Dehiscence or Infection
time frame: 2 years
description: Participants with wound dehiscence or infection requiring unplanned dressing changes, antibiotics, or surgery
arm group label: Incisional Wound Vac
arm group type: Active Comparator
description: We will attach sponges and a suction tube to the incision after surgery. We will leave it on for 72 hours. From then on, patients will get the care that patients normally get after spinal fusion surgery.
arm group label: Normal Gauze Bandage Group
arm group type: Active Comparator
description: We will cover patients incision with regular gauze bandages. These are the bandages that patients normally get after spinal fusion surgery. They will be left on for 72 hours.
intervention type: Device
intervention name: Incisional Wound Vac
arm group label: Incisional Wound Vac
other name: Incisional vacuum-assisted closure therapy
intervention type: Other
intervention name: Standard Bandage
arm group label: Normal Gauze Bandage Group
other name: Gauze Bandage
other name: Gauze
criteria: 
gender: All
minimum age: 0 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ying G Li, MD
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: G Ying Li
investigator title: MD
mesh term: Scoliosis
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 