<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/NCT03229824</url>
  </required_header>
  <id_info>
    <org_study_id>CEI/1090/16</org_study_id>
    <nct_id>NCT03229824</nct_id>
  </id_info>
  <brief_title>Use of Clorhexidine Dressings to Reduce Surgical Site Infections in Breast Cancer Surgery. A Controlled Clinical Trial</brief_title>
  <official_title>Randomized Controlled Trial to Reduce Surgical Site Infections in Breast Cancer Surgery With Clorhexidine Gluconate Securement Dressing (Tegaderm CHG)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Cancerología</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Instituto Nacional de Rehabilitacion</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Cancerología</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>
      Surgical site infection (SSI) after breast and axillary surgery occurs more often than for&#xD;
      other clean surgical procedures. Infection in the setting of sick woman could delay the&#xD;
      adjuvant therapy and result increase morbidity and mortality. Also this increased costs&#xD;
      associated with health care.Surgical drains have been noted as a potential source for&#xD;
      surgical site infections. The primary aim of the study is to determine if chlorhexidine&#xD;
      occlusive dressings applied to the intervention drain sites effectively decreases rates of&#xD;
      bacterial colonization in drain fluid and drain tips compared to standard care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following approval by the National Cancer Institute Review Board, eligible subjects will be&#xD;
      recruited prospectively from the Breast Cancer Department at National Cancer Institute,&#xD;
      México from November 2016 to November 2017. Individuals with confirmed cancer undergoing&#xD;
      total mastectomy (TM), modified radical mastectomy (MRM) and/or axillary lymph node&#xD;
      dissection (ALND) in which surgical drains are going to be used will be identified through&#xD;
      the surgical scheduling sheet. If the subjects are eligible according to the inclusion&#xD;
      criteria, the will be interviewed by one of the main researchers. In the initial interview&#xD;
      the informed consent will be read and signed. Also the study coordinator will collect the&#xD;
      data of interest from the medical records and will register it in a data collection sheet&#xD;
      specially created for this project.&#xD;
&#xD;
      Following informed consent, participants will be randomize to either the standard drain care&#xD;
      regimen or the drain antisepsis regimen by a computerized randomization program, using&#xD;
      dynamic allocation and stratifying by surgical procedure (radical surgery or conservative&#xD;
      surgery). Subjects who had bilateral cancer underwent to the same regimen for both sides. The&#xD;
      operating surgeon will know the assigned treatment arm at the end of the surgery.&#xD;
&#xD;
      The surgery will consist on placing a chlorhexidine gluconate occlusive adhesive dressing to&#xD;
      the drains side at the end of the surgery. The dressing will be changed each 7 (+-1) days&#xD;
      until the drain is removed.&#xD;
&#xD;
      All the participants and the principal take-carers, despite of the group of participation,&#xD;
      will be personal instructed by a member of the research team in the first hours of the&#xD;
      postoperative, before the departure. In addition, they will be given paper based instructions&#xD;
      for the general care of the drain and the surgery wound.&#xD;
&#xD;
      For the experimental group, the dressing will be changed each 7(+-1) days; The site of the&#xD;
      insertion must be cleaned with 70% concentration isopropyl alcohol towels. The evaluation and&#xD;
      quantification of the drained fluid will be done every 12 hours as it is done usually in&#xD;
      these patients.&#xD;
&#xD;
      The patients will be followed for 30 days from the surgery until the resolution of the&#xD;
      infectious complication, if it occurs. The patients will go at the end of the first&#xD;
      postoperative week (POP 7+-1). In each visit, the coordinator of the study will register the&#xD;
      information of the patient in the register sheet. In each visit the patient will be&#xD;
      evaluated, the characteristics of the surgical wound and the characteristics of drain fluid&#xD;
      will be consigned in the protocol register sheet. The investigator will verify that the&#xD;
      participants have correctly done the clean-up the drain.&#xD;
&#xD;
      All patients will undergo semiquantitative cultures of the drain bulb at the first and second&#xD;
      week postoperative. Also the investigators will take the distal part of the internal segment&#xD;
      of each removed drainage tube for semiquantitative culture. All participants will be&#xD;
      evaluated for clinical signs of infection and for any adverse reactions to the drain&#xD;
      antisepsis at the follow-up visits. In case of a surgical site infection, the patient will&#xD;
      receive the right treatment and will remain in surveillance until the resolution.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2016</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">April 30, 2018</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>Number of subjects with drain bulb fluid bacterial colonization at the first and second week postoperative.</measure>
    <time_frame>Approximately 1 or 2 weeks after surgery</time_frame>
    <description>Bacterial growth was defined as plate growth &gt;10*5 colony forming unit (CFU). Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects with drain tip bacterial colonization at removal.</measure>
    <time_frame>Approximately at the second and/or third week after surgery</time_frame>
    <description>Bacterial growth was defined as plate growth &gt;15 CFU by semiquantitative technique or &gt;10*5 CFU by sonication and fluid culture. Drains were removed at variable times across patients, per clinical indication.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Surgical Site Infection Within 30 Days</measure>
    <time_frame>Approximately 30 days after surgery</time_frame>
    <description>Surgical site infection was diagnosed according the definitions given by the Centers for Disease Control and Prevention (CDC).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">116</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Antiseptic occlusive dressing group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site and the tubing with a cotton swab dipped in rubbing alcohol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Antiseptic occlusive dressing group</intervention_name>
    <description>A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.</description>
    <arm_group_label>Antiseptic occlusive dressing group</arm_group_label>
    <other_name>Tegaderm CHG Dressing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Females minimum age 18 able to give informed consent&#xD;
&#xD;
          -  Breast cancer confirmed by histopathology&#xD;
&#xD;
          -  Patients undergoing unilateral or bilateral mastectomy with or without immediate&#xD;
             expander reconstruction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Males&#xD;
&#xD;
          -  Patients who deny informed consent&#xD;
&#xD;
          -  Prior radiation therapy to the sick breast.&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Patients undergoing immediate breast reconstruction with Deep Inferior&#xD;
&#xD;
          -  Epigastric Perforator (DIEP) o Transverse Rectus Abdominal Muscle techniques (TRAM) .&#xD;
&#xD;
          -  Emergency procedures&#xD;
&#xD;
          -  Documented allergy to chlorhexidine gluconate&#xD;
&#xD;
          -  Antibiotic use in the fourteen days prior to surgical date&#xD;
&#xD;
          -  Patients with a history or suspicion of breast cancer surgery outside the INCan in the&#xD;
             previous three months.&#xD;
&#xD;
          -  Patients who do not speak spanish, diagnosed with a psychiatric disorder and in whom a&#xD;
             minimum follow-up of 14 days couldn't be feasible because of operative difficulties&#xD;
             (eg.&#xD;
&#xD;
        place of residence or reference to other health institutions).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Instituto Nacional de Cancerología</name>
      <address>
        <city>Mexico City</city>
        <state>DF</state>
        <zip>14080</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
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  <verification_date>November 2018</verification_date>
  <study_first_submitted>April 21, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>November 9, 2018</last_update_submitted>
  <last_update_submitted_qc>November 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Cancerología</investigator_affiliation>
    <investigator_full_name>MYRNA CANDELARIA, MD PHD</investigator_full_name>
    <investigator_title>Ethics Commissioner</investigator_title>
  </responsible_party>
  <keyword>Drain antisepsis</keyword>
  <keyword>Bacterial colonization</keyword>
  <keyword>Surgical site infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Infective Agents, Local</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Results at the end of study</ipd_description>
  </patient_data>
  <pending_results>
    <submitted>January 10, 2019</submitted>
    <returned>April 5, 2019</returned>
  </pending_results>
  <!-- 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/NCT03229824
org study id: CEI/1090/16
nct id: NCT03229824
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Surgical site infection (SSI) after breast and axillary surgery occurs more often than for
      other clean surgical procedures. Infection in the setting of sick woman could delay the
      adjuvant therapy and result increase morbidity and mortality. Also this increased costs
      associated with health care.Surgical drains have been noted as a potential source for
      surgical site infections. The primary aim of the study is to determine if chlorhexidine
      occlusive dressings applied to the intervention drain sites effectively decreases rates of
      bacterial colonization in drain fluid and drain tips compared to standard care.
Following approval by the National Cancer Institute Review Board, eligible subjects will be
      recruited prospectively from the Breast Cancer Department at National Cancer Institute,
      México from November 2016 to November 2017. Individuals with confirmed cancer undergoing
      total mastectomy (TM), modified radical mastectomy (MRM) and/or axillary lymph node
      dissection (ALND) in which surgical drains are going to be used will be identified through
      the surgical scheduling sheet. If the subjects are eligible according to the inclusion
      criteria, the will be interviewed by one of the main researchers. In the initial interview
      the informed consent will be read and signed. Also the study coordinator will collect the
      data of interest from the medical records and will register it in a data collection sheet
      specially created for this project.

      Following informed consent, participants will be randomize to either the standard drain care
      regimen or the drain antisepsis regimen by a computerized randomization program, using
      dynamic allocation and stratifying by surgical procedure (radical surgery or conservative
      surgery). Subjects who had bilateral cancer underwent to the same regimen for both sides. The
      operating surgeon will know the assigned treatment arm at the end of the surgery.

      The surgery will consist on placing a chlorhexidine gluconate occlusive adhesive dressing to
      the drains side at the end of the surgery. The dressing will be changed each 7 (+-1) days
      until the drain is removed.

      All the participants and the principal take-carers, despite of the group of participation,
      will be personal instructed by a member of the research team in the first hours of the
      postoperative, before the departure. In addition, they will be given paper based instructions
      for the general care of the drain and the surgery wound.

      For the experimental group, the dressing will be changed each 7(+-1) days; The site of the
      insertion must be cleaned with 70% concentration isopropyl alcohol towels. The evaluation and
      quantification of the drained fluid will be done every 12 hours as it is done usually in
      these patients.

      The patients will be followed for 30 days from the surgery until the resolution of the
      infectious complication, if it occurs. The patients will go at the end of the first
      postoperative week (POP 7+-1). In each visit, the coordinator of the study will register the
      information of the patient in the register sheet. In each visit the patient will be
      evaluated, the characteristics of the surgical wound and the characteristics of drain fluid
      will be consigned in the protocol register sheet. The investigator will verify that the
      participants have correctly done the clean-up the drain.

      All patients will undergo semiquantitative cultures of the drain bulb at the first and second
      week postoperative. Also the investigators will take the distal part of the internal segment
      of each removed drainage tube for semiquantitative culture. All participants will be
      evaluated for clinical signs of infection and for any adverse reactions to the drain
      antisepsis at the follow-up visits. In case of a surgical site infection, the patient will
      receive the right treatment and will remain in surveillance until the resolution.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of subjects with drain bulb fluid bacterial colonization at the first and second week postoperative.
time frame: Approximately 1 or 2 weeks after surgery
description: Bacterial growth was defined as plate growth >10*5 colony forming unit (CFU). Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.
measure: Number of subjects with drain tip bacterial colonization at removal.
time frame: Approximately at the second and/or third week after surgery
description: Bacterial growth was defined as plate growth >15 CFU by semiquantitative technique or >10*5 CFU by sonication and fluid culture. Drains were removed at variable times across patients, per clinical indication.
measure: Number of Subjects With Surgical Site Infection Within 30 Days
time frame: Approximately 30 days after surgery
description: Surgical site infection was diagnosed according the definitions given by the Centers for Disease Control and Prevention (CDC).
arm group label: Antiseptic occlusive dressing group
arm group type: Experimental
description: A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.
arm group label: Standard care
arm group type: No Intervention
description: Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site and the tubing with a cotton swab dipped in rubbing alcohol.
intervention type: Device
intervention name: Antiseptic occlusive dressing group
description: A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.
arm group label: Antiseptic occlusive dressing group
other name: Tegaderm CHG Dressing
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Mexico
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responsible party type: Principal Investigator
investigator affiliation: National Institute of Cancerología
investigator full name: MYRNA CANDELARIA, MD PHD
investigator title: Ethics Commissioner
mesh term: Infections
mesh term: Surgical Wound Infection
mesh term: Breast Neoplasms
mesh term: Anti-Infective Agents, Local
sharing ipd: Undecided
ipd description: Results at the end of study
submitted: January 10, 2019
returned: April 5, 2019