<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/NCT04483063</url>
  </required_header>
  <id_info>
    <org_study_id>B-BR-108-052</org_study_id>
    <nct_id>NCT04483063</nct_id>
  </id_info>
  <brief_title>Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?</brief_title>
  <official_title>Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cheng-Kung University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cheng-Kung University Hospital</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 purpose of our study was to investigate whether preoperative skin cleaning on face, neck,&#xD;
      and chest with chlorhexidine could reduce suture contamination of C. acnes in arthroscopic&#xD;
      rotator cuff repair. We hypothesized that preoperative skin cleaning on face, neck and chest&#xD;
      with chlorhexidine can reduce C. acnes contamination on sutures in arthroscopic rotator cuff&#xD;
      repair.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 23, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Culture positive</measure>
    <time_frame>Within 2 weeks postoperatively</time_frame>
    <description>Culture positive for C. acnes from the suture used in the arthroscopy</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>C. Acnes</condition>
  <condition>Arthroscopic Rotator Cuff Repair</condition>
  <arm_group>
    <arm_group_label>Extended shoulder group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2% chlorhexidine gluconate skin cleanser over the not only the operative shoulder and axilla but also the chest, back, neck, and face</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Shoulder group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2% chlorhexidine gluconate skin cleanser over the operative shoulder and axilla</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Skin prepare with soap as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>2% chlorhexidine gluconate skin cleanser</intervention_name>
    <description>2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery</description>
    <arm_group_label>Extended shoulder group</arm_group_label>
    <arm_group_label>Shoulder group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary arthroscopic rotator cuff repair&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  younger than 18 years&#xD;
&#xD;
          -  having previous shoulder surgeries or shoulder infection episodes&#xD;
&#xD;
          -  having a history of allergy to chlorhexidine&#xD;
&#xD;
          -  who refused to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chih-Kai Hong, MD</last_name>
    <phone>886-6-2353535</phone>
    <phone_ext>5237</phone_ext>
    <email>yayahong@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>70428</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>National Cheng Kung U Hospital</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 21, 2020</last_update_submitted>
  <last_update_submitted_qc>July 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Cheng-Kung University Hospital</investigator_affiliation>
    <investigator_full_name>Kai-Lan Hsu</investigator_full_name>
    <investigator_title>Attending physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acne Vulgaris</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>
  </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/NCT04483063
org study id: B-BR-108-052
nct id: NCT04483063
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of our study was to investigate whether preoperative skin cleaning on face, neck,
      and chest with chlorhexidine could reduce suture contamination of C. acnes in arthroscopic
      rotator cuff repair. We hypothesized that preoperative skin cleaning on face, neck and chest
      with chlorhexidine can reduce C. acnes contamination on sutures in arthroscopic rotator cuff
      repair.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Culture positive
time frame: Within 2 weeks postoperatively
description: Culture positive for C. acnes from the suture used in the arthroscopy
arm group label: Extended shoulder group
arm group type: Experimental
description: 2% chlorhexidine gluconate skin cleanser over the not only the operative shoulder and axilla but also the chest, back, neck, and face
arm group label: Shoulder group
arm group type: Experimental
description: 2% chlorhexidine gluconate skin cleanser over the operative shoulder and axilla
arm group label: Control group
arm group type: No Intervention
description: Skin prepare with soap as usual
intervention type: Drug
intervention name: 2% chlorhexidine gluconate skin cleanser
description: 2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery
arm group label: Extended shoulder group
arm group label: Shoulder group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Chih-Kai Hong, MD
phone: 886-6-2353535
phone ext: 5237
email: yayahong@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Cheng-Kung University Hospital
investigator full name: Kai-Lan Hsu
investigator title: Attending physician
mesh term: Acne Vulgaris
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
sharing ipd: No