<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/NCT02241915</url>
  </required_header>
  <id_info>
    <org_study_id>HS-10-00471</org_study_id>
    <nct_id>NCT02241915</nct_id>
  </id_info>
  <brief_title>Use of a Microbial Sealant to Reduce Surgical Site Infections.</brief_title>
  <acronym>Integuseal</acronym>
  <official_title>Microbial Sealants Do Not Decrease Surgical Site Infection for Clean Contaminated Colorectal Procedures.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgical site infections (SSI) are costly complications that may cause significant morbidity&#xD;
      and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS)&#xD;
      are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of&#xD;
      benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we&#xD;
      hypothesized that a microbial sealant could reduce the rate of SSI by half for clean&#xD;
      contaminated colorectal procedures (Class 2).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>Phase 4</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>Incidence of SSI with and without microbial sealant.</measure>
    <time_frame>15 Months</time_frame>
    <description>Determine the rate of SSI when microbial sealant (InteguSEAL© Kimberly-Clark) is used compared to control (no microbial sealant).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subgroup incidence of SSI with and without microbial sealant</measure>
    <time_frame>15 months</time_frame>
    <description>Compare SSI for open vs. laparoscopy colectomy, age, BMI, diabetes and morbidity (ASA class), hospital readmission, reoperation and wound dehiscence with and without microbial sealant.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Surgical Site Infection</condition>
  <condition>SCIP</condition>
  <arm_group>
    <arm_group_label>Microbial Sealant</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Integuseal (Kimberly Clark)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>No microbial sealant</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open Colorectal Surgery</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Microbial Sealant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Surgery</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Microbial Sealant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Nonemergent colon and/or rectal abdominal surgical procedures&#xD;
&#xD;
          2. Women of child-bearing potential must have a negative serum HCG assay prior to surgery&#xD;
&#xD;
          3. Ages ≥18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known history of hypersensitivity to cyanoacrylate, formaldehyde or acetone products.&#xD;
&#xD;
          2. Undergoing emergency surgery (urgent surgery is allowed if informed consent is&#xD;
             obtained and the study procedures can be performed). Emergency surgery includes cases&#xD;
             where standard bowel preparation and other preoperative assessments cannot be done.&#xD;
&#xD;
          3. Undergoing a significant concomitant surgical procedure (e.g., Whipple &amp; organ&#xD;
             transplant surgery).&#xD;
&#xD;
             The following concomitant procedures are allowed: appendectomy, cholecystectomy,&#xD;
             oophorectomy, liver biopsy/wedge resection (but not liver resection), cystectomy.&#xD;
&#xD;
          4. History of prior laparotomy within the last 60 days of this planned procedure.&#xD;
&#xD;
          5. Planned to undergo a second laparotomy or colorectal surgical procedure (e.g.&#xD;
             colostomy or ileostomy takedown) within 60 days of this planned first procedure.&#xD;
&#xD;
          6. Evidence preoperatively of any of the following: sepsis, severe sepsis, or septic&#xD;
             shock (note that SIRS alone is not an exclusion criteria).6, 7&#xD;
&#xD;
          7. Preoperative severe neutropenia defined as total neutrophil count ≤500 × 106/L.&#xD;
&#xD;
          8. Current abdominal wall infection/surgical site infection from previous&#xD;
             laparotomy/laparoscopy or for any reason.&#xD;
&#xD;
          9. Receiving antibiotic therapy within the 1 week prior to the date of surgery.&#xD;
&#xD;
         10. Preoperative evaluation suggests intra-abdominal process that might preclude full&#xD;
             closure of the skin.&#xD;
&#xD;
         11. Preoperative serum creatinine &gt; 3 mg/dL or renal failure requiring dialysis.&#xD;
&#xD;
         12. History of ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer.&#xD;
&#xD;
         13. History of major organ transplantation, including bone marrow transplantation.&#xD;
&#xD;
         14. Taking systemic steroids &gt;10 mg prednisone daily or remicade within 2 weeks prior to&#xD;
             surgery or a history of a current immunosuppressive condition (eg, symptomatic HIV&#xD;
             infection), defined as a CD4 count &lt; 200.&#xD;
&#xD;
         15. Pregnant, lactating, or of childbearing potential not practicing a birth control&#xD;
             method with a high degree of reliability (defined in section 3.1).&#xD;
&#xD;
         16. Participation within 30 days before the start of this study in any experimental drug&#xD;
             or device study, or currently participating in a study in which the administration of&#xD;
             investigational drug or device within 60 days is anticipated.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Los Angeles County/USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 13, 2014</last_update_submitted>
  <last_update_submitted_qc>September 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Michael Doorly</investigator_full_name>
    <investigator_title>Faculty Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Surgical 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/NCT02241915
org study id: HS-10-00471
nct id: NCT02241915
lead sponsor: 
has dmc: No
Surgical site infections (SSI) are costly complications that may cause significant morbidity
      and increase the cost of care, particularly in colorectal surgery. Microbial sealants (MS)
      are a new class of wound barriers aimed at decreasing SSI, however there is only evidence of
      benefit in clean Class 1 procedures. Based on its success in Class 1 procedures, we
      hypothesized that a microbial sealant could reduce the rate of SSI by half for clean
      contaminated colorectal procedures (Class 2).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Incidence of SSI with and without microbial sealant.
time frame: 15 Months
description: Determine the rate of SSI when microbial sealant (InteguSEAL© Kimberly-Clark) is used compared to control (no microbial sealant).
measure: Subgroup incidence of SSI with and without microbial sealant
time frame: 15 months
description: Compare SSI for open vs. laparoscopy colectomy, age, BMI, diabetes and morbidity (ASA class), hospital readmission, reoperation and wound dehiscence with and without microbial sealant.
arm group label: Microbial Sealant
arm group type: Active Comparator
description: Integuseal (Kimberly Clark)
arm group label: Control
arm group type: Sham Comparator
description: No microbial sealant
intervention type: Procedure
intervention name: Open Colorectal Surgery
arm group label: Control
arm group label: Microbial Sealant
intervention type: Procedure
intervention name: Laparoscopic Surgery
arm group label: Control
arm group label: Microbial Sealant
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Michael Doorly
investigator title: Faculty Fellow
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Surgical Wound Infection