<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/NCT03014778</url>
  </required_header>
  <id_info>
    <org_study_id>0093-15-EMC</org_study_id>
    <nct_id>NCT03014778</nct_id>
  </id_info>
  <brief_title>Efficacy of Two Vaginal Solutions in Preoperative Use</brief_title>
  <official_title>Efficacy Comparison of Two Vaginal Solutions for Preoperative Use in Candidate Women for Vaginal Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HaEmek Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>HaEmek Medical Center, Israel</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is necessary in order to provide proof the effectiveness of Chlorhexidine&#xD;
      gluconate and its safety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is well known from the literature that the use of Povidone-iodone based solution for&#xD;
      vaginal preparation before surgery is fraught with side effects and sensitivity, and often&#xD;
      does not provide sufficient eradication of colonies of pathogens from the operation field.&#xD;
&#xD;
      It is also known that Chlorhexidine gluconate in low concentration provides a better result&#xD;
      and does not cause side effects more than Povidone-iodone, but the chlorhexidine is still not&#xD;
      approved for washing the mucous membranes. This study is necessary in order to provide proof&#xD;
      of its effectiveness and safety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 1, 2017</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changing in the number of colonies that grew at every stage</measure>
    <time_frame>Before the washing, 10 minutes after washing, 30 minutes after washing.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Signs of local irritation mucosa after each bathing preparations by looking at the mucosa, at the end of the clinical assessment.</measure>
    <time_frame>30 minutes after washing.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The appearance of signs of systemic allergic reactions after each bathing by looking at the mucosa, at the end of the clinical assessment.</measure>
    <time_frame>Before the washing, 10 minutes after washing, 30 minutes after washing.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Vaginal Surgeries</condition>
  <arm_group>
    <arm_group_label>The Chlorhexidine gluconate arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>35 women undergoing surgery will be vaginally pre-op washed by 0.05% chlorhexidine gluconate, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The Povidone iodine arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>35 women undergoing surgery will be vaginally pre-op washed by 10% Povidone iodine, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>The Chlorhexidine gluconate 0.05%</intervention_name>
    <description>Washing vagina pre- operatively with Chlorhexidine gluconate 0.05%</description>
    <arm_group_label>The Chlorhexidine gluconate arm</arm_group_label>
    <other_name>Sterets unisept</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10% Povidone iodine</intervention_name>
    <description>Washing vagina pre- operatively with 10% Povidone iodine</description>
    <arm_group_label>The Povidone iodine arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients over the age of 18&#xD;
&#xD;
          2. Candidates for surgery (TOT- Trans Obturator Tape, cystoscopy, the introduction /&#xD;
             removal of the stent the ureter, ureteroscopy), local or general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A pregnant woman or post-partum.&#xD;
&#xD;
          2. A woman with known sensitivity to iodine, povidon or chlorhexidine.&#xD;
&#xD;
          3. Previous pelvic surgeries within three months from the surgery planned.&#xD;
&#xD;
          4. Patients taking antibiotics within one month from the surgery planned.&#xD;
&#xD;
          5. Immunological failure patients.&#xD;
&#xD;
          6. Patient unwilling to participate in the study.&#xD;
&#xD;
          7. Patients who require the appointment of a guardian condition&#xD;
&#xD;
          8. Women assigned to undergo a regular cystoscopy (no further action).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharon Tzemah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haemek MC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sharon Tzemah, MD</last_name>
    <phone>97252-6678244</phone>
    <email>sharon_tze1@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Gross, MD</last_name>
    <phone>97254-6676778</phone>
    <email>michael_gr1@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Haemek Medical Center</name>
      <address>
        <city>'Afula</city>
        <state>Afula</state>
        <zip>1834111</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sharon Tzemach, DR</last_name>
      <phone>972-526678244</phone>
      <email>sharon_tze1@clalit.org.il</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.</citation>
    <PMID>20054046</PMID>
  </reference>
  <reference>
    <citation>American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. 2013 Sep;122(3):718-20. doi: 10.1097/01.AOG.0000433982.36184.95.</citation>
    <PMID>23963423</PMID>
  </reference>
  <reference>
    <citation>Niedner R. Cytotoxicity and sensitization of povidone-iodine and other frequently used anti-infective agents. Dermatology. 1997;195 Suppl 2:89-92. doi: 10.1159/000246038.</citation>
    <PMID>9403263</PMID>
  </reference>
  <reference>
    <citation>Vorherr H, Vorherr UF, Mehta P, Ulrich JA, Messer RH. Vaginal absorption of povidone-iodine. JAMA. 1980 Dec 12;244(23):2628-9.</citation>
    <PMID>7431610</PMID>
  </reference>
  <reference>
    <citation>Kjolhede P, Halili S, Lofgren M. Vaginal cleansing and postoperative infectious morbidity in vaginal hysterectomy. A register study from the Swedish National Register for Gynecological Surgery. Acta Obstet Gynecol Scand. 2011 Jan;90(1):63-71. doi: 10.1111/j.1600-0412.2010.01023.x. Epub 2010 Nov 26.</citation>
    <PMID>21275917</PMID>
  </reference>
  <reference>
    <citation>Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. doi: 10.1016/j.ajog.2004.08.010.</citation>
    <PMID>15695981</PMID>
  </reference>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 9, 2017</study_first_posted>
  <last_update_submitted>February 26, 2018</last_update_submitted>
  <last_update_submitted_qc>February 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>HaEmek Medical Center, Israel</investigator_affiliation>
    <investigator_full_name>Sharon Tzemach</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <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>Povidone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03014778
org study id: 0093-15-EMC
nct id: NCT03014778
lead sponsor: 
has dmc: No
This study is necessary in order to provide proof the effectiveness of Chlorhexidine
      gluconate and its safety.
It is well known from the literature that the use of Povidone-iodone based solution for
      vaginal preparation before surgery is fraught with side effects and sensitivity, and often
      does not provide sufficient eradication of colonies of pathogens from the operation field.

      It is also known that Chlorhexidine gluconate in low concentration provides a better result
      and does not cause side effects more than Povidone-iodone, but the chlorhexidine is still not
      approved for washing the mucous membranes. This study is necessary in order to provide proof
      of its effectiveness and safety.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Changing in the number of colonies that grew at every stage
time frame: Before the washing, 10 minutes after washing, 30 minutes after washing.
measure: Signs of local irritation mucosa after each bathing preparations by looking at the mucosa, at the end of the clinical assessment.
time frame: 30 minutes after washing.
measure: The appearance of signs of systemic allergic reactions after each bathing by looking at the mucosa, at the end of the clinical assessment.
time frame: Before the washing, 10 minutes after washing, 30 minutes after washing.
arm group label: The Chlorhexidine gluconate arm
arm group type: Experimental
description: 35 women undergoing surgery will be vaginally pre-op washed by 0.05% chlorhexidine gluconate, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash.
arm group label: The Povidone iodine arm
arm group type: Active Comparator
description: 35 women undergoing surgery will be vaginally pre-op washed by 10% Povidone iodine, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash.
intervention type: Drug
intervention name: The Chlorhexidine gluconate 0.05%
description: Washing vagina pre- operatively with Chlorhexidine gluconate 0.05%
arm group label: The Chlorhexidine gluconate arm
other name: Sterets unisept
intervention type: Drug
intervention name: 10% Povidone iodine
description: Washing vagina pre- operatively with 10% Povidone iodine
arm group label: The Povidone iodine arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sharon Tzemah, MD
role: Principal Investigator
affiliation: Haemek MC
last name: Sharon Tzemah, MD
phone: 97252-6678244
email: sharon_tze1@clalit.org.il
last name: Michael Gross, MD
phone: 97254-6676778
email: michael_gr1@clalit.org.il
facility: 
status: Recruiting
contact: 
country: Israel
citation: Darouiche RO, Wall MJ Jr, Itani KM, Otterson MF, Webb AL, Carrick MM, Miller HJ, Awad SS, Crosby CT, Mosier MC, Alsharif A, Berger DH. Chlorhexidine-Alcohol versus Povidone-Iodine for Surgical-Site Antisepsis. N Engl J Med. 2010 Jan 7;362(1):18-26. doi: 10.1056/NEJMoa0810988.
PMID: 20054046
citation: American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. 2013 Sep;122(3):718-20. doi: 10.1097/01.AOG.0000433982.36184.95.
PMID: 23963423
citation: Niedner R. Cytotoxicity and sensitization of povidone-iodine and other frequently used anti-infective agents. Dermatology. 1997;195 Suppl 2:89-92. doi: 10.1159/000246038.
PMID: 9403263
citation: Vorherr H, Vorherr UF, Mehta P, Ulrich JA, Messer RH. Vaginal absorption of povidone-iodine. JAMA. 1980 Dec 12;244(23):2628-9.
PMID: 7431610
citation: Kjolhede P, Halili S, Lofgren M. Vaginal cleansing and postoperative infectious morbidity in vaginal hysterectomy. A register study from the Swedish National Register for Gynecological Surgery. Acta Obstet Gynecol Scand. 2011 Jan;90(1):63-71. doi: 10.1111/j.1600-0412.2010.01023.x. Epub 2010 Nov 26.
PMID: 21275917
citation: Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. doi: 10.1016/j.ajog.2004.08.010.
PMID: 15695981
responsible party type: Principal Investigator
investigator affiliation: HaEmek Medical Center, Israel
investigator full name: Sharon Tzemach
investigator title: Dr
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Povidone-Iodine
mesh term: Povidone
sharing ipd: No