<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/NCT04446923</url>
  </required_header>
  <id_info>
    <org_study_id>RICBEC1-UCM</org_study_id>
    <nct_id>NCT04446923</nct_id>
  </id_info>
  <brief_title>Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing</brief_title>
  <official_title>Surgical Hand Antisepsis With Propan-ol-1 60% Per Rubbing and Scrubbing in Accordance With European Norm Regulation 12791</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad Complutense de Madrid</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad Complutense de Madrid</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 to compare bactericidal efficacy using the&#xD;
      reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub&#xD;
      method 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 rub and scrub.&#xD;
      Samples will be taken from the hands of each volunteer after a surgical hands antiseptic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 28, 2020</start_date>
  <completion_date type="Actual">July 20, 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 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>Reduction of bacterial load immediately after hand scrub</measure>
    <time_frame>Change from bacterial load at 5 minutes.</time_frame>
    <description>Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction of bacterial load after 3 hours of hand scrub</measure>
    <time_frame>Change from bacterial load at 3 hours.</time_frame>
    <description>Participants will scrub the liquid 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>Skin Diseases</condition>
  <condition>Surgical Site Infection</condition>
  <arm_group>
    <arm_group_label>Hand antisepsis by scrub</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hand antisepsis by scrub using propan-ol-1 60%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hand antisepsis by rub</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Hand antisepsis by rub using propan-ol-1 60%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hand antisepsis by scrub</intervention_name>
    <description>Surgical Hand scrubbing using P-1 of 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 by scrub</arm_group_label>
    <other_name>Propanolol</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hand antisepsis by scrub</intervention_name>
    <description>Surgical Hand rubbing using P-1 of 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 by rub</arm_group_label>
    <other_name>Propanolol</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, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ricardo becerro de Bengoa Vallejo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ricardo Becerro de Bengoa Vallejo</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad Complutense de Madrid</investigator_affiliation>
    <investigator_full_name>César Calvo Lobo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>hand antisepsis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Skin Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Propranolol</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/NCT04446923
org study id: RICBEC1-UCM
nct id: NCT04446923
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study evaluates the effects of to compare bactericidal efficacy using the
      reference antiseptic product propan-ol-1 60% using the hand rub method versus hand scrub
      method 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 rub and scrub.
      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 design is used
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The samples will be sent to the laboratory with numbers.
measure: Reduction of bacterial load immediately after hand scrub
time frame: Change from bacterial load at 5 minutes.
description: Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure.
measure: Reduction of bacterial load after 3 hours of hand scrub
time frame: Change from bacterial load at 3 hours.
description: Participants will scrub the liquid vigorously from hand to the wrists according with the standard handrub procedure after 3 hours
arm group label: Hand antisepsis by scrub
arm group type: Experimental
description: Hand antisepsis by scrub using propan-ol-1 60%
arm group label: Hand antisepsis by rub
arm group type: Active Comparator
description: Hand antisepsis by rub using propan-ol-1 60%
intervention type: Drug
intervention name: Hand antisepsis by scrub
description: Surgical Hand scrubbing using P-1 of 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 by scrub
other name: Propanolol
intervention type: Drug
intervention name: Hand antisepsis by scrub
description: Surgical Hand rubbing using P-1 of 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 by rub
other name: Propanolol
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ricardo Becerro de Bengoa Vallejo, PhD
role: Principal Investigator
affiliation: Ricardo becerro de Bengoa Vallejo
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad Complutense de Madrid
investigator full name: César Calvo Lobo
investigator title: Principal Investigator
mesh term: Surgical Wound Infection
mesh term: Skin Diseases
mesh term: Propranolol
sharing ipd: No
ipd description: A number will be assigned to each participant