<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/NCT03001102</url>
  </required_header>
  <id_info>
    <org_study_id>EE-UFMG</org_study_id>
    <nct_id>NCT03001102</nct_id>
  </id_info>
  <brief_title>Preoperative Bath in Patients Submitted to Hip Arthroplasty</brief_title>
  <official_title>Preoperative Bath in Patients Submitted to Hip Arthroplasty: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do estado de Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Federal University of Minas Gerais</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms&#xD;
      which purpose is verify the effects of nursing intervention preoperative bathing with 4%&#xD;
      chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the&#xD;
      prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the recommendation in several guidelines of preoperative bathing with 4%&#xD;
      chlorhexidine gluconate as a measure for the prevention of SSI, there is no evidence in the&#xD;
      literature that support this practice. The objective of this study is to evaluate the effect&#xD;
      of nursing intervention: preoperative bath using 4% chlorhexidine gluconate solutions, 10%&#xD;
      povidone iodine degermante or soap without antiseptic for the prevention of SSI in patients&#xD;
      undergoing elective hip arthroplasty surgery. The specific objectives are to compare the&#xD;
      incidence of SSI in the three interventions, to assess the most effective intervention for&#xD;
      the prevention of surgical infection and to estimate the frequency of allergic reactions&#xD;
      caused by the use of the solutions. Two intervention groups (4% Chlorhexidine gluconate and&#xD;
      PVPI10%) and a control group (without antiseptic soap) composed of 52 patients undergoing hip&#xD;
      arthroplasty in each group will be randomized to perform the baths in the period from may&#xD;
      2015 to june 2017. Before the intervention, nasal swabs will be collected of patients to&#xD;
      investigate colonization by Staphylococcus aureus.&#xD;
&#xD;
      The expected result is lower ISC rate with the proposed measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">March 2018</completion_date>
  <primary_completion_date type="Actual">January 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infection of Surgical Site (SSI)</measure>
    <time_frame>During the first 90 days after surgery</time_frame>
    <description>The infections that develop after the surgical procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Allergic reactions</measure>
    <time_frame>In the first hours after procedure</time_frame>
    <description>Adverse reaction to a given product</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Surgical Wound Infection</condition>
  <arm_group>
    <arm_group_label>Bathing with 4% Chlorhexidine gluconate</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Two baths with chlorhexidine using precise methods, including to scrubb the whole body with 50mL of undiluted solution, at night before surgery and the morning of surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bathing with10% PVPI degermante</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two baths with PVPI using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bathing with soap without antiseptic.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two baths with soap using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>4% Chlorhexidine gluconate</intervention_name>
    <description>Cationic biguanide - antimicrobial action rubbing in the skin.</description>
    <arm_group_label>Bathing with 4% Chlorhexidine gluconate</arm_group_label>
    <other_name>HiBiScrub</other_name>
    <other_name>4% Chlorhexidine degermante</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>10% PVPI degermante</intervention_name>
    <description>Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.</description>
    <arm_group_label>Bathing with10% PVPI degermante</arm_group_label>
    <other_name>Betadine</other_name>
    <other_name>10% Povidone iodine degermante</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Soap without antiseptic</intervention_name>
    <description>Liquid soap with glycerin, neutral pH. Skin cleansing</description>
    <arm_group_label>Bathing with soap without antiseptic.</arm_group_label>
    <other_name>Non-medicated soap</other_name>
    <other_name>Soap</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be 18 or older;&#xD;
&#xD;
          -  Elective procedure of total hip arthroplasty&#xD;
&#xD;
          -  No report of infectious focus at the surgical site&#xD;
&#xD;
          -  Know to respond to the clinical signs of a surgical infection or having a person&#xD;
             responsible with this ability&#xD;
&#xD;
          -  Do not be a nasal carrier of Staphylococcus aureus before surgery&#xD;
&#xD;
          -  Have access to fixed or mobile phone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient treating surgical site infection&#xD;
&#xD;
          -  Emergency hip prosthesis surgery or orthopedic trauma&#xD;
&#xD;
          -  Nasal carriers of Staphylococcus aureus before surgery&#xD;
&#xD;
          -  Previous history of allergic reactions to the products used in the bat&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lúcia MC Franco, PhD student</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Minas Gerais</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Federal University of Minas Gerais</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>February 26, 2019</last_update_submitted>
  <last_update_submitted_qc>February 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federal University of Minas Gerais</investigator_affiliation>
    <investigator_full_name>Lucia Maciel de Castro Franco</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Preoperative Care</keyword>
  <keyword>Baths</keyword>
  <keyword>Chlorhexidine</keyword>
  <keyword>Soaps</keyword>
  <keyword>Povidone-Iodine</keyword>
  <keyword>Arthroplasty, Replacement, Hip</keyword>
  <keyword>Surgical Wound Infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
    <mesh_term>Chlorhexidine gluconate</mesh_term>
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Anti-Infective Agents, Local</mesh_term>
    <mesh_term>Povidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.</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/NCT03001102
org study id: EE-UFMG
nct id: NCT03001102
lead sponsor: 
collaborator: 
has dmc: No
Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms
      which purpose is verify the effects of nursing intervention preoperative bathing with 4%
      chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the
      prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.
Despite the recommendation in several guidelines of preoperative bathing with 4%
      chlorhexidine gluconate as a measure for the prevention of SSI, there is no evidence in the
      literature that support this practice. The objective of this study is to evaluate the effect
      of nursing intervention: preoperative bath using 4% chlorhexidine gluconate solutions, 10%
      povidone iodine degermante or soap without antiseptic for the prevention of SSI in patients
      undergoing elective hip arthroplasty surgery. The specific objectives are to compare the
      incidence of SSI in the three interventions, to assess the most effective intervention for
      the prevention of surgical infection and to estimate the frequency of allergic reactions
      caused by the use of the solutions. Two intervention groups (4% Chlorhexidine gluconate and
      PVPI10%) and a control group (without antiseptic soap) composed of 52 patients undergoing hip
      arthroplasty in each group will be randomized to perform the baths in the period from may
      2015 to june 2017. Before the intervention, nasal swabs will be collected of patients to
      investigate colonization by Staphylococcus aureus.

      The expected result is lower ISC rate with the proposed measures.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Infection of Surgical Site (SSI)
time frame: During the first 90 days after surgery
description: The infections that develop after the surgical procedure
measure: Allergic reactions
time frame: In the first hours after procedure
description: Adverse reaction to a given product
arm group label: Bathing with 4% Chlorhexidine gluconate
arm group type: Sham Comparator
description: Two baths with chlorhexidine using precise methods, including to scrubb the whole body with 50mL of undiluted solution, at night before surgery and the morning of surgery.
arm group label: Bathing with10% PVPI degermante
arm group type: Experimental
description: Two baths with PVPI using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.
arm group label: Bathing with soap without antiseptic.
arm group type: Active Comparator
description: Two baths with soap using precise methods, including to scrubb the whole body with 50mL of undiluted solution for each bath, at night before surgery and the morning of surgery.
intervention type: Device
intervention name: 4% Chlorhexidine gluconate
description: Cationic biguanide - antimicrobial action rubbing in the skin.
arm group label: Bathing with 4% Chlorhexidine gluconate
other name: HiBiScrub
other name: 4% Chlorhexidine degermante
intervention type: Device
intervention name: 10% PVPI degermante
description: Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.
arm group label: Bathing with10% PVPI degermante
other name: Betadine
other name: 10% Povidone iodine degermante
intervention type: Device
intervention name: Soap without antiseptic
description: Liquid soap with glycerin, neutral pH. Skin cleansing
arm group label: Bathing with soap without antiseptic.
other name: Non-medicated soap
other name: Soap
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lúcia MC Franco, PhD student
role: Principal Investigator
affiliation: Federal University of Minas Gerais
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Federal University of Minas Gerais
investigator full name: Lucia Maciel de Castro Franco
investigator title: PhD
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Surgical Wound
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Povidone-Iodine
mesh term: Anti-Infective Agents, Local
mesh term: Povidone
sharing ipd: No
ipd description: The study and the information provided will be confidential and used only for purposes of this research. Disclosure of information will be anonymous and in conjunction with the responses of a group of people, never individually.