<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/NCT02219776</url>
  </required_header>
  <id_info>
    <org_study_id>201400113</org_study_id>
    <nct_id>NCT02219776</nct_id>
  </id_info>
  <brief_title>Decreasing Infection In Arthroscopic Shoulder Surgery</brief_title>
  <official_title>Decreasing Proprionbacterium Acne Skin Colonization Prior to Arthroscopic Shoulder Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McLaren Health Care</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McLaren Health Care</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite the use of a standard preoperative skin disinfectant prior to shoulder surgery&#xD;
      propionibacterium acne remains a leading cause of post-operative infections. The purpose of&#xD;
      this study is to evaluate effectiveness of topical benzoyl peroxide as an adjuvant to&#xD;
      chlorhexidine-impregnated skin preparation in attempting to lower the colonization&#xD;
      propionibacterium acne prior to surgery. This study will take cultures from patients who are&#xD;
      randomly assigned into groups that receive and do not receive benzoyl peroxide as additional&#xD;
      skin prep prior to elective shoulder surgery and compare quantified culture results.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With IRB approval and informed consent to participate in the study, patients scheduled for&#xD;
      elective shoulder arthroscopy will be randomly selected and placed into 1 of 2 groups. Both&#xD;
      groups will adhere to the surgeon's preoperative protocol of showering the night before with&#xD;
      instructions to scrub the operative shoulder including the axilla with a chlorhexidine scrub&#xD;
      brush. Group 1 will be treated &quot;per protocol&quot; and only be given instructions to use&#xD;
      chlorhexidine. While group 2 will be provided a chlorhexidine scrub brush and a 1.5oz bottle&#xD;
      of 10% benzoyl peroxide emollient to be applied after using the chlorhexidine scrub. The&#xD;
      benzoyl peroxide should not be washed off prior to surgery.&#xD;
&#xD;
      Thirty minutes prior to incision, intravenous antibiotics, cefazolin or clindamycin if&#xD;
      penicillin intolerant, will be administered per protocol. Dry anaerobic culturettes will be&#xD;
      taken at the location of the expected posterior portal location before and after the&#xD;
      application of the chloraprep solution. At the time of surgery both groups will undergo&#xD;
      preoperative skin preparation, in sterile fashion, with our institutions &quot;standard&quot; protocol&#xD;
      utilizing ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol; Enturia, El Paso,&#xD;
      Texas). In addition, a 3mm full thickness skin punch biopsy will be taken after, application&#xD;
      of chlorprep. Biopsies will be immediately placed, by the surgeon, in sterile receptacle with&#xD;
      sterile saline and sent to our microbiology department. The biopsy site will be incorporated&#xD;
      into the portal incision and will be closed appropriately minimizing the morbidity of&#xD;
      obtaining the biopsy.&#xD;
&#xD;
      The culture results will be recorded into a &quot;dummy&quot; account on McLaren's electronic medical&#xD;
      records program. This account ensures that the costs of the study are not charged to the&#xD;
      patient as well as blinding the patient and surgeon of the their results. The patient&#xD;
      correlating information will only be known to Dr. Fine and they will be kept in a password&#xD;
      protect computer document which will be kept in a off campus protected locked location.&#xD;
&#xD;
      The Microbiology lab will place the swab specimens in 1 ml of saline, vortex them, and&#xD;
      inoculate 0.01 mL onto an anaerobic blood agar plate. A chopped meat broth will also be&#xD;
      inoculated. The punch biopsies will be ground and then inoculated to an anaerobic blood agar&#xD;
      plate and a chopped meat broth. The anaerobic plates will be incubated in an anaerobic&#xD;
      chamber at 35°C. The plates and broth will be examined daily for the first 4 days, then on&#xD;
      days 7, 10 and 14 and any growth screened to determine if P. acnes is present. Results will&#xD;
      be reported as &quot;no P. acnes isolated&quot; or as &quot;&lt;X&gt;CFU/mL P. acnes&quot; for the swab specimens. No&#xD;
      colony count can be issued for the biopsies. These will be reported semi-quantitatively as&#xD;
      rare, few, moderate or many. All plates will be read and counted manually by a laboratory&#xD;
      technician who is not involved in the study and has been blinded from preoperative prep used.&#xD;
      If any growth is detected, the sample will be considered positive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">June 2021</completion_date>
  <primary_completion_date type="Actual">June 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial Growth</measure>
    <time_frame>14 days from culture</time_frame>
    <description>Skin swabs and biopsy will be cultured for 14 days in media specific for growing P.Acne</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Post Operative Infection Arthroscopic Shoulder Surgery</condition>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>Chlorhexidine Standard of Care Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of Chlorhexidine to cleanse pre-operative surgery site</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Benzoyl Peroxide Experimental Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of Chlorhexidine scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Benzoyl Peroxide solution Plus Chlorhexidine Scrub</intervention_name>
    <description>Subjects will be provided instructions on how to use and apply the chlorhexidine using a scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient application</description>
    <arm_group_label>Benzoyl Peroxide Experimental Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care - Chlorhexidine Scrub only</intervention_name>
    <description>Subjects will be given instructions on how to apply the Chlorhexidine using a scrub brush</description>
    <arm_group_label>Chlorhexidine Standard of Care Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Elective arthroscopic shoulder surgery&#xD;
&#xD;
          2. Ages &gt; 18&#xD;
&#xD;
          3. Male and Female&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Active Infection&#xD;
&#xD;
          2. History of ipsilateral prior shoulder surgery&#xD;
&#xD;
          3. History of prior shoulder infection&#xD;
&#xD;
          4. Current use of Antibiotics&#xD;
&#xD;
          5. History of immunosuppression&#xD;
&#xD;
          6. Open wounds&#xD;
&#xD;
          7. History of Inflammatory arthritis&#xD;
&#xD;
          8. Allergy to benzoyl peroxide&#xD;
&#xD;
          9. Allergy to chlorhexidine&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Landon R Fine, DO</last_name>
    <role>Principal Investigator</role>
    <affiliation>McLaren Greater Lansing</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McLaren Greater Lansing</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>28910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 16, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infection,</keyword>
  <keyword>Proprionbacterium Acne,</keyword>
  <keyword>Shoulder,</keyword>
  <keyword>skin preparation</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>
  </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>Benzoyl Peroxide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02219776
org study id: 201400113
nct id: NCT02219776
lead sponsor: 
has dmc: No
Despite the use of a standard preoperative skin disinfectant prior to shoulder surgery
      propionibacterium acne remains a leading cause of post-operative infections. The purpose of
      this study is to evaluate effectiveness of topical benzoyl peroxide as an adjuvant to
      chlorhexidine-impregnated skin preparation in attempting to lower the colonization
      propionibacterium acne prior to surgery. This study will take cultures from patients who are
      randomly assigned into groups that receive and do not receive benzoyl peroxide as additional
      skin prep prior to elective shoulder surgery and compare quantified culture results.
With IRB approval and informed consent to participate in the study, patients scheduled for
      elective shoulder arthroscopy will be randomly selected and placed into 1 of 2 groups. Both
      groups will adhere to the surgeon's preoperative protocol of showering the night before with
      instructions to scrub the operative shoulder including the axilla with a chlorhexidine scrub
      brush. Group 1 will be treated "per protocol" and only be given instructions to use
      chlorhexidine. While group 2 will be provided a chlorhexidine scrub brush and a 1.5oz bottle
      of 10% benzoyl peroxide emollient to be applied after using the chlorhexidine scrub. The
      benzoyl peroxide should not be washed off prior to surgery.

      Thirty minutes prior to incision, intravenous antibiotics, cefazolin or clindamycin if
      penicillin intolerant, will be administered per protocol. Dry anaerobic culturettes will be
      taken at the location of the expected posterior portal location before and after the
      application of the chloraprep solution. At the time of surgery both groups will undergo
      preoperative skin preparation, in sterile fashion, with our institutions "standard" protocol
      utilizing ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol; Enturia, El Paso,
      Texas). In addition, a 3mm full thickness skin punch biopsy will be taken after, application
      of chlorprep. Biopsies will be immediately placed, by the surgeon, in sterile receptacle with
      sterile saline and sent to our microbiology department. The biopsy site will be incorporated
      into the portal incision and will be closed appropriately minimizing the morbidity of
      obtaining the biopsy.

      The culture results will be recorded into a "dummy" account on McLaren's electronic medical
      records program. This account ensures that the costs of the study are not charged to the
      patient as well as blinding the patient and surgeon of the their results. The patient
      correlating information will only be known to Dr. Fine and they will be kept in a password
      protect computer document which will be kept in a off campus protected locked location.

      The Microbiology lab will place the swab specimens in 1 ml of saline, vortex them, and
      inoculate 0.01 mL onto an anaerobic blood agar plate. A chopped meat broth will also be
      inoculated. The punch biopsies will be ground and then inoculated to an anaerobic blood agar
      plate and a chopped meat broth. The anaerobic plates will be incubated in an anaerobic
      chamber at 35°C. The plates and broth will be examined daily for the first 4 days, then on
      days 7, 10 and 14 and any growth screened to determine if P. acnes is present. Results will
      be reported as "no P. acnes isolated" or as "<X>CFU/mL P. acnes" for the swab specimens. No
      colony count can be issued for the biopsies. These will be reported semi-quantitatively as
      rare, few, moderate or many. All plates will be read and counted manually by a laboratory
      technician who is not involved in the study and has been blinded from preoperative prep used.
      If any growth is detected, the sample will be considered positive.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Bacterial Growth
time frame: 14 days from culture
description: Skin swabs and biopsy will be cultured for 14 days in media specific for growing P.Acne
arm group label: Chlorhexidine Standard of Care Arm
arm group type: Active Comparator
description: Use of Chlorhexidine to cleanse pre-operative surgery site
arm group label: Benzoyl Peroxide Experimental Arm
arm group type: Experimental
description: Use of Chlorhexidine scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient
intervention type: Drug
intervention name: Benzoyl Peroxide solution Plus Chlorhexidine Scrub
description: Subjects will be provided instructions on how to use and apply the chlorhexidine using a scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient application
arm group label: Benzoyl Peroxide Experimental Arm
intervention type: Other
intervention name: Standard of Care - Chlorhexidine Scrub only
description: Subjects will be given instructions on how to apply the Chlorhexidine using a scrub brush
arm group label: Chlorhexidine Standard of Care Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Landon R Fine, DO
role: Principal Investigator
affiliation: McLaren Greater Lansing
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Chlorhexidine
mesh term: Chlorhexidine gluconate
mesh term: Benzoyl Peroxide
sharing ipd: Undecided