<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/NCT01676051</url>
  </required_header>
  <id_info>
    <org_study_id>PRO12080340</org_study_id>
    <nct_id>NCT01676051</nct_id>
  </id_info>
  <brief_title>Surgical Prep in Hand Surgery</brief_title>
  <official_title>Efficacy of Surgical Preparation Solutions in Hand Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purposes of this study are to identify the common bacterial flora on the hand and&#xD;
      evaluate the efficacy of readily available skin-preparation solutions in the elimination of&#xD;
      bacterial pathogens from the surgical site following skin preparation. The null hypothesis is&#xD;
      that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in&#xD;
      pre-operative skin preparation in clean, elective hand surgery cases.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of positive cultures</measure>
    <time_frame>after skin prep solution has dried</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">240</enrollment>
  <condition>Surgical Scrubbing</condition>
  <condition>Disinfection</condition>
  <arm_group>
    <arm_group_label>Chloraprep</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Duraprep</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Betadine only</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Skin culture</intervention_name>
    <description>Culture swab used to culture skin adjacent to incision</description>
    <arm_group_label>Betadine only</arm_group_label>
    <arm_group_label>Chloraprep</arm_group_label>
    <arm_group_label>Duraprep</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing clean, elective hand surgery without implants&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  the following procedures (carpal tunnel release, trigger finger release, cyst&#xD;
             excision, 1st dorsal compartment release)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prisoners&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Fowler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montefiore Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Savage JW, Weatherford BM, Sugrue PA, Nolden MT, Liu JC, Song JK, Haak MH. Efficacy of surgical preparation solutions in lumbar spine surgery. J Bone Joint Surg Am. 2012 Mar 21;94(6):490-4. doi: 10.2106/JBJS.K.00471.</citation>
    <PMID>22437997</PMID>
  </reference>
  <reference>
    <citation>Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.</citation>
    <PMID>19651954</PMID>
  </reference>
  <reference>
    <citation>Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.</citation>
    <PMID>15866959</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 23, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 30, 2012</study_first_posted>
  <last_update_submitted>October 28, 2017</last_update_submitted>
  <last_update_submitted_qc>October 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>John Fowler</investigator_full_name>
    <investigator_title>Fellow</investigator_title>
  </responsible_party>
  <!-- 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/NCT01676051
org study id: PRO12080340
nct id: NCT01676051
lead sponsor: 
has dmc: Yes
The purposes of this study are to identify the common bacterial flora on the hand and
      evaluate the efficacy of readily available skin-preparation solutions in the elimination of
      bacterial pathogens from the surgical site following skin preparation. The null hypothesis is
      that there is no difference in the efficacy of Chloraprep, Duraprep, and betadine in
      pre-operative skin preparation in clean, elective hand surgery cases.
observational model: Cohort
time perspective: Prospective
measure: Number of positive cultures
time frame: after skin prep solution has dried
arm group label: Chloraprep
arm group label: Duraprep
arm group label: Betadine only
intervention type: Other
intervention name: Skin culture
description: Culture swab used to culture skin adjacent to incision
arm group label: Betadine only
arm group label: Chloraprep
arm group label: Duraprep
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: John Fowler, MD
role: Principal Investigator
affiliation: University of Pittsburgh
facility: 
facility: 
country: United States
citation: Savage JW, Weatherford BM, Sugrue PA, Nolden MT, Liu JC, Song JK, Haak MH. Efficacy of surgical preparation solutions in lumbar spine surgery. J Bone Joint Surg Am. 2012 Mar 21;94(6):490-4. doi: 10.2106/JBJS.K.00471.
PMID: 22437997
citation: Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009 Aug;91(8):1949-53. doi: 10.2106/JBJS.H.00768.
PMID: 19651954
citation: Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005 May;87(5):980-5. doi: 10.2106/JBJS.D.01977.
PMID: 15866959
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: John Fowler
investigator title: Fellow