<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/NCT01700504</url>
  </required_header>
  <id_info>
    <org_study_id>2012/0009</org_study_id>
    <nct_id>NCT01700504</nct_id>
  </id_info>
  <brief_title>Effect of Gentamicin Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Elche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Elche</source>
  <brief_summary>
    <textblock>
      The effect of axillary lavage with a gentamicin solution before wound closure will reduce the&#xD;
      drainage volume and subsequently day of drainage removal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inclusion criteria will be a diagnosis of mammary neoplasms and plans to undergo an elective&#xD;
      ALND of Berg´s levels I and II due to axillary metastasis determined preoperatively by core&#xD;
      biopsy or evidence of metastasis in the SLNB in the intraoperative or in the differed&#xD;
      analysis. Exclusion criteria will be chronic renal failure due to possible toxicity of&#xD;
      gentamicin and patients undergoing a modified radical mastectomy.&#xD;
&#xD;
      The patients will be randomized by means of an Internet randomization module into 2 groups:&#xD;
      those patients undergoing 2 lavages of the axillary surgical bed with normal saline (Group 1)&#xD;
      and those ones first undergoing lavage with normal saline followed by a second lavage with a&#xD;
      gentamicin solution (Group 2).&#xD;
&#xD;
      Surgical dissection will be performed using harmonic scalpel (Ultracision, Ethicon&#xD;
      Endosurgery, Johnson and Johnson, Cincinnati, OH, USA). Once finished the ALND, a&#xD;
      Jackson-Pratt drain will be left in place and connected to a low pressure vacuum device.&#xD;
&#xD;
      Methodology: Irrigation technique and extraction of microbiological samples:&#xD;
&#xD;
      The lavage will be performed immediately prior to closure of the wound, once placed the&#xD;
      drainage into the cavity. In both groups, prior to the lavage, a microbiological sample from&#xD;
      the surgical bed will be obtained with a swab (sample 1), followed by a lavage with 500 ml&#xD;
      normal saline. After aspiration of the saline, a new microbiological sample will be obtained&#xD;
      (sample 2). In Group 1 a second lavage with 500 ml normal saline will be performed, while in&#xD;
      Group 2 the second lavage will be performed with an antibiotic solution, including gentamicin&#xD;
      (240 mg) dissolved in 500 ml normal saline. After aspirating this second lavage, a third&#xD;
      microbiological sample will be obtained in the same way as the two previous ones, in both&#xD;
      groups (sample 3).&#xD;
&#xD;
      Indication of drain removal and obtention of sample 4:&#xD;
&#xD;
      After discharge, the patient will be asked to quantify the drainage volume daily. Drain will&#xD;
      be removed when drainage volume was &lt;30 ml/day. The drainage volume of the last day was&#xD;
      collected in a syringe for microbiological study (sample 4).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>Phase 3</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Drainage volume</measure>
    <time_frame>7 days</time_frame>
    <description>The drainage volumen between groups (interventional and control)will be analyzed.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Axillary Drainage Volume After Lymph Node Dissection.</condition>
  <arm_group>
    <arm_group_label>Gentamicin lavage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normal saline lavage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients undergoing 2 axillary lavages with 500ml of normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Axillary lavage with gentamicin solution</intervention_name>
    <description>Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution</description>
    <arm_group_label>Gentamicin lavage</arm_group_label>
    <arm_group_label>Normal saline lavage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of mammary neoplasms and plans to undergo an elective ALND of Berg´s levels&#xD;
             I and II due to axillary metastasis determined preoperatively by core biopsy or&#xD;
             evidence of metastasis in the SLNB in the intraoperative or in the differed analysis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic renal failure due to possible toxicity of gentamicin&#xD;
&#xD;
          -  patients undergoing a modified radical mastectomy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital General de Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 2, 2012</last_update_submitted>
  <last_update_submitted_qc>October 2, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Elche</investigator_affiliation>
    <investigator_full_name>Jaime Ruiz-Tovar, MD, PhD</investigator_full_name>
    <investigator_title>Associate Professor Universidad Miguel Hernandez</investigator_title>
  </responsible_party>
  <keyword>Axillary drainage volume</keyword>
  <keyword>Lavage with gentamicin solution</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gentamicins</mesh_term>
  </intervention_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/NCT01700504
org study id: 2012/0009
nct id: NCT01700504
lead sponsor: 
The effect of axillary lavage with a gentamicin solution before wound closure will reduce the
      drainage volume and subsequently day of drainage removal.
Inclusion criteria will be a diagnosis of mammary neoplasms and plans to undergo an elective
      ALND of Berg´s levels I and II due to axillary metastasis determined preoperatively by core
      biopsy or evidence of metastasis in the SLNB in the intraoperative or in the differed
      analysis. Exclusion criteria will be chronic renal failure due to possible toxicity of
      gentamicin and patients undergoing a modified radical mastectomy.

      The patients will be randomized by means of an Internet randomization module into 2 groups:
      those patients undergoing 2 lavages of the axillary surgical bed with normal saline (Group 1)
      and those ones first undergoing lavage with normal saline followed by a second lavage with a
      gentamicin solution (Group 2).

      Surgical dissection will be performed using harmonic scalpel (Ultracision, Ethicon
      Endosurgery, Johnson and Johnson, Cincinnati, OH, USA). Once finished the ALND, a
      Jackson-Pratt drain will be left in place and connected to a low pressure vacuum device.

      Methodology: Irrigation technique and extraction of microbiological samples:

      The lavage will be performed immediately prior to closure of the wound, once placed the
      drainage into the cavity. In both groups, prior to the lavage, a microbiological sample from
      the surgical bed will be obtained with a swab (sample 1), followed by a lavage with 500 ml
      normal saline. After aspiration of the saline, a new microbiological sample will be obtained
      (sample 2). In Group 1 a second lavage with 500 ml normal saline will be performed, while in
      Group 2 the second lavage will be performed with an antibiotic solution, including gentamicin
      (240 mg) dissolved in 500 ml normal saline. After aspirating this second lavage, a third
      microbiological sample will be obtained in the same way as the two previous ones, in both
      groups (sample 3).

      Indication of drain removal and obtention of sample 4:

      After discharge, the patient will be asked to quantify the drainage volume daily. Drain will
      be removed when drainage volume was <30 ml/day. The drainage volume of the last day was
      collected in a syringe for microbiological study (sample 4).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Drainage volume
time frame: 7 days
description: The drainage volumen between groups (interventional and control)will be analyzed.
arm group label: Gentamicin lavage
arm group type: Experimental
description: Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution
arm group label: Normal saline lavage
arm group type: Active Comparator
description: Patients undergoing 2 axillary lavages with 500ml of normal saline
intervention type: Drug
intervention name: Axillary lavage with gentamicin solution
description: Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution
arm group label: Gentamicin lavage
arm group label: Normal saline lavage
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Elche
investigator full name: Jaime Ruiz-Tovar, MD, PhD
investigator title: Associate Professor Universidad Miguel Hernandez
mesh term: Gentamicins