<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/NCT01700803</url>
  </required_header>
  <id_info>
    <org_study_id>Betadine CS</org_study_id>
    <nct_id>NCT01700803</nct_id>
  </id_info>
  <brief_title>Povidone Iodine and Cesarean Section Wound Infections</brief_title>
  <official_title>Povidone Iodine 10% Versus 7.5% Hand Scrub and Cesarean Section Wound Infections: A Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by&#xD;
      Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section&#xD;
      wound infections &amp; compare side effects of both agents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For centuries, hand washing with soap and water has been considered the main approach for&#xD;
      personal hygiene. In the community, hand hygiene has been known to prevent infectious&#xD;
      diseases and to decrease the burden of disease. Currently, hand hygiene is considered the&#xD;
      most important measure for preventing the spread of pathogens in health-care settings.&#xD;
&#xD;
      There are multiple agents used for surgical hand scrubbing as alcohol, chlorhexidine,&#xD;
      iodine/iodophors, para-chloro-meta-xylenol &amp; triclosan. Ideally, the optimum antiseptic used&#xD;
      for scrub should have broad spectrum of activity, persistent effect &amp; fast acting.&#xD;
      Unfortunately most studies evaluating surgical scrub antiseptics have focused on measuring&#xD;
      hand bacterial colony counts. No randomized clinical trials have evaluated the impact of&#xD;
      surgical scrub choice on surgical site infection risk &amp; proven its efficiency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">April 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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference of incidence of surgical site infection between both groups</measure>
    <time_frame>4 month</time_frame>
    <description>Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The difference in the side effects between both groups e.g. dermatitis</measure>
    <time_frame>4 month</time_frame>
    <description>Determine the difference in incidence of side effects between Povidone Iodine 10% versus 7.5% hand scrub</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3231</enrollment>
  <condition>Wound Infections</condition>
  <arm_group>
    <arm_group_label>Povidone Iodine 10%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using Povidone Iodine 10% hand scrub before caesarian section</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Povidone Iodine 7.5% hand scrub</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using Povidone Iodine 7.5% hand scrub before caesarian section</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Povidone Iodine 10% vand cesarean section wound infections</intervention_name>
    <arm_group_label>Povidone Iodine 10%</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Povidone Iodine 7.5% vand cesarean section wound infections</intervention_name>
    <arm_group_label>Povidone Iodine 7.5% hand scrub</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective caesarian section (CS)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diabetes,&#xD;
&#xD;
          -  immuno-compromised patients&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Women Health Hospital - Assiut university</name>
      <address>
        <city>Assiut</city>
        <zip>71111</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>October 3, 2012</last_update_submitted>
  <last_update_submitted_qc>October 3, 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>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Khairy Ali</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Betadine</keyword>
  <keyword>Povidine Iodine</keyword>
  <keyword>Hand scrubbing</keyword>
  <keyword>Cesarean section wound infections</keyword>
  <keyword>post cesarean section</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iodine</mesh_term>
    <mesh_term>Cadexomer iodine</mesh_term>
    <mesh_term>Povidone-Iodine</mesh_term>
    <mesh_term>Povidone</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/NCT01700803
org study id: Betadine CS
nct id: NCT01700803
lead sponsor: 
has dmc: Yes
The aim of this randomized clinical trial is to compare the efficiency of hand scrubbing by
      Povidone-Iodine solution 10% over 7.5% concentration in decreasing post-cesarean section
      wound infections & compare side effects of both agents.
For centuries, hand washing with soap and water has been considered the main approach for
      personal hygiene. In the community, hand hygiene has been known to prevent infectious
      diseases and to decrease the burden of disease. Currently, hand hygiene is considered the
      most important measure for preventing the spread of pathogens in health-care settings.

      There are multiple agents used for surgical hand scrubbing as alcohol, chlorhexidine,
      iodine/iodophors, para-chloro-meta-xylenol & triclosan. Ideally, the optimum antiseptic used
      for scrub should have broad spectrum of activity, persistent effect & fast acting.
      Unfortunately most studies evaluating surgical scrub antiseptics have focused on measuring
      hand bacterial colony counts. No randomized clinical trials have evaluated the impact of
      surgical scrub choice on surgical site infection risk & proven its efficiency.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: The difference of incidence of surgical site infection between both groups
time frame: 4 month
description: Determine the difference in incidence of surgical site infection between Povidone Iodine 10% versus 7.5% hand scrub
measure: The difference in the side effects between both groups e.g. dermatitis
time frame: 4 month
description: Determine the difference in incidence of side effects between Povidone Iodine 10% versus 7.5% hand scrub
arm group label: Povidone Iodine 10%
arm group type: Experimental
description: Using Povidone Iodine 10% hand scrub before caesarian section
arm group label: Povidone Iodine 7.5% hand scrub
arm group type: Experimental
description: Using Povidone Iodine 7.5% hand scrub before caesarian section
intervention type: Drug
intervention name: Povidone Iodine 10% vand cesarean section wound infections
arm group label: Povidone Iodine 10%
intervention type: Drug
intervention name: Povidone Iodine 7.5% vand cesarean section wound infections
arm group label: Povidone Iodine 7.5% hand scrub
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Khairy Ali
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Wound Infection
mesh term: Wounds and Injuries
mesh term: Iodine
mesh term: Cadexomer iodine
mesh term: Povidone-Iodine
mesh term: Povidone