<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/NCT04454619</url>
  </required_header>
  <id_info>
    <org_study_id>RICBEC</org_study_id>
    <nct_id>NCT04454619</nct_id>
  </id_info>
  <brief_title>Pre-surgical Antisepsis Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate</brief_title>
  <acronym>sorbectol</acronym>
  <official_title>Effectiveness of Pre-surgical Hand Washing in Reducing Bacterial Load, Using an Alcoholic Solution of Chlorhexidine Digluconate and Potassium Sorbate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Ortopedico y Quirurgico del Pie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Ortopedico y Quirurgico del Pie</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>
      The present study evaluates the effects of bactericidal load reduction after surgical hand&#xD;
      scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a&#xD;
      surgical hand scrub antisepsis with addition of a solution of chlorhexidine digluconate and&#xD;
      potassium sorbate in order to test if pass the standard european norm 12791.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators conducted a crossover clinical trial to evaluate the antiseptic&#xD;
      effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by scrub using the&#xD;
      reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub&#xD;
      antisepsis with addition of a solution of chlorhexidine digluconate and potassium sorbate in&#xD;
      order to test if pass the standard european norm 12791. Samples will be taken from the hands&#xD;
      of each volunteer after a surgical hands antiseptic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2020</start_date>
  <completion_date type="Actual">August 15, 2020</completion_date>
  <primary_completion_date type="Actual">July 18, 2020</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Crossover Assignment Crossover design is used</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>The samples will be sent to the laboratory with numbers</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change of bacterial load measured in CFU immediately after hand scrub</measure>
    <time_frame>Change from bacterial load at 5 minutes</time_frame>
    <description>Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of bacterial loadmeaured in CFU after 3 hours of hand scrub</measure>
    <time_frame>Change from bacterial load at 3 hours</time_frame>
    <description>Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure after 3 hours</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Antisepsis</condition>
  <arm_group>
    <arm_group_label>Hand antisepsis with propanolol-1 60%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Effectiveness of pre-surgical hand washing in reducing bacterial load using propanolol-1 60% as control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hand antisepsis with Clorhexidina and solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hand antisepsis with Clorhexidine and solution</intervention_name>
    <description>Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side</description>
    <arm_group_label>Hand antisepsis with Clorhexidina and solution</arm_group_label>
    <arm_group_label>Hand antisepsis with propanolol-1 60%</arm_group_label>
    <other_name>Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants without systemic pathologies, with healthy skin of the hands and short&#xD;
             fingernails.&#xD;
&#xD;
          -  They do not use substances with antibacterial action.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taken antibiotics before 10 days of the intervention.&#xD;
&#xD;
          -  Wear any jewellery on the hands&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ricardo Becerro de Bengoa Vallejo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Complutense de Madrid</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro ortopedico y quirurgico del pie</name>
      <address>
        <city>Madrid</city>
        <state>Madrid.</state>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>August 28, 2020</last_update_submitted>
  <last_update_submitted_qc>August 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Ortopedico y Quirurgico del Pie</investigator_affiliation>
    <investigator_full_name>Ricardo Becerro de Bengoa Vallejo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>A number will be assigned to each participant</ipd_description>
  </patient_data>
  <!-- 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/NCT04454619
org study id: RICBEC
nct id: NCT04454619
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study evaluates the effects of bactericidal load reduction after surgical hand
      scrub antisepsis using the reference antiseptic product propan-ol-1 60% as control versus a
      surgical hand scrub antisepsis with addition of a solution of chlorhexidine digluconate and
      potassium sorbate in order to test if pass the standard european norm 12791.
The investigators conducted a crossover clinical trial to evaluate the antiseptic
      effectiveness of preoperative surgical scrubbing using propan-ol-1 60% by scrub using the
      reference antiseptic product propan-ol-1 60% as control versus a surgical hand scrub
      antisepsis with addition of a solution of chlorhexidine digluconate and potassium sorbate in
      order to test if pass the standard european norm 12791. Samples will be taken from the hands
      of each volunteer after a surgical hands antiseptic.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Crossover Assignment Crossover design is used
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The samples will be sent to the laboratory with numbers
measure: Change of bacterial load measured in CFU immediately after hand scrub
time frame: Change from bacterial load at 5 minutes
description: Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure
measure: Change of bacterial loadmeaured in CFU after 3 hours of hand scrub
time frame: Change from bacterial load at 3 hours
description: Participants will scrub the antiseptic solution vigorously from hand to the wrists according with the standard handrub procedure after 3 hours
arm group label: Hand antisepsis with propanolol-1 60%
arm group type: Active Comparator
description: Effectiveness of pre-surgical hand washing in reducing bacterial load using propanolol-1 60% as control
arm group label: Hand antisepsis with Clorhexidina and solution
arm group type: Experimental
description: chlorhexidine gluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate.
intervention type: Drug
intervention name: Hand antisepsis with Clorhexidine and solution
description: Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side
arm group label: Hand antisepsis with Clorhexidina and solution
arm group label: Hand antisepsis with propanolol-1 60%
other name: Clorhexidine and alholic solution dicluconate cloehexidine and potassium sorbate
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ricardo Becerro de Bengoa Vallejo
role: Principal Investigator
affiliation: Universidad Complutense de Madrid
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Centro Ortopedico y Quirurgico del Pie
investigator full name: Ricardo Becerro de Bengoa Vallejo
investigator title: Principal Investigator
mesh term: Pharmaceutical Solutions
sharing ipd: No
ipd description: A number will be assigned to each participant