<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/NCT02260479</url>
  </required_header>
  <id_info>
    <org_study_id>OpPm2013</org_study_id>
    <nct_id>NCT02260479</nct_id>
  </id_info>
  <brief_title>Preheated Skin Disinfection vs Room-temperature on Bacterial Colonization During Pace Device Implantation</brief_title>
  <official_title>The Effect of Preheated Skin Disinfection in Relation to Room-temperature Skin Disinfection on Bacterial Colonization During Pace Device Implantation: a Randomized Controlled Non-inferiority Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Örebro University, Sweden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Örebro University, Sweden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim was to investigate if preheated skin disinfection with Chlorhexidine in&#xD;
      alcohol was non-inferior compared to room-temperature regarding skin colonization as well as&#xD;
      bacterial colonization in wound, skin temperature and patients experiences.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients were randomly assigned to preheated (36ᵒC, intervention) skin disinfection&#xD;
      (Chlorhexidine 5mg/ml in 70% alcohol) or room temperature (20ᵒC, control) skin disinfection&#xD;
      (Chlorhexidine 5mg/ml in 70% alcohol). Patient´s enrollment to operation was made by an&#xD;
      external controller who had no closer knowledge of present study. All patients were asked to&#xD;
      participate in that sequence they arrived to the OR department when study nurse was present.&#xD;
      Assignment took place directly after patients consent. Patients were stratified into gender&#xD;
      and thereafter randomly allocated to preheated or control group, based on a&#xD;
      computer-generated randomization list made by an independent statistician. Patients showered,&#xD;
      scrubbing their whole body and hair twice with 4% chlorhexidine soap Descutan® (Fresenius&#xD;
      Kabi AB, Uppsala, Sweden) prior to surgery. and patients were prepared after skin&#xD;
      disinfection with a microbial sealant. Most patients were elective and arrived the morning of&#xD;
      surgery to the hospital. Following standard procedures, intravenously administered antibiotic&#xD;
      prophylaxis (cloxacillin 2 g) was administrated at the ward 30 minutes before surgery. In the&#xD;
      OR the patients wore a disposable cap and were positioned on the operating table. The OR&#xD;
      temperature were 19°C with upward displacement ventilation. Sterile disposable surgical gowns&#xD;
      (Samutprakarn, Thailand/Mölnlycke Health Care AB, Göteborg, Sweden) and indicator gloves&#xD;
      (Selangor, Malaysia/Mölnlycke Health Care AB Göteborg, Sweden) were worn by the surgeon and&#xD;
      OR nurse. Other OR staff (n=2) wore cotton scrubs, short-sleeved tunic shirt with cuffs at&#xD;
      the arms, and trousers with cuffs at the ankles. They also wore disposable helmets and&#xD;
      facemasks. Both groups were given skin disinfection during 2 minutes with the same amount of&#xD;
      solution (Chlorhexidine 5mg/ml in 70% alcohol). The skin disinfection (Chlorhexidine 5mg/ml,&#xD;
      in alcohol) was stored in room-temperature and was measured to keep 20ᵒC while the preheated&#xD;
      was stored in a warming cupboard who kept 36ᵒC. The participants were disinfected from cheek&#xD;
      down over sternum according to routine procedures. Sterile material for draping and clothing&#xD;
      were for single use only. Cultures were obtained at four occasions using a nylon flocked swab&#xD;
      (Copan ESwab, Italia SpA): before skin disinfection on skin surface; after skin disinfection&#xD;
      on skin surface; directly after the incision, at completion of the incision, and finally&#xD;
      before start of closing sutures. Swab cultures were rubbed for 15 seconds slightly moist with&#xD;
      saline on skin surface (incision site). Swabs taken in the wound were rubbed along the inside&#xD;
      of the incision for 15 seconds with a dry swab. Surgery was performed by two cardiologists.&#xD;
      Cultures were kept cold until arrival at the Department of Laboratory medicine, Clinical&#xD;
      Microbiology. Cultures were taken care of and analyzed according to a specific protocol&#xD;
      designed especially for the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 2/Phase 3</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial cultures</measure>
    <time_frame>perioperative</time_frame>
    <description>Skin cultures (eSwab) taken before and after skin disinfection</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical site infections</measure>
    <time_frame>Three month after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bacterial colonization in wound</measure>
    <time_frame>perioperative</time_frame>
    <description>Cultures taken in wound at time for incision and before closing sutures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Skin temperature</measure>
    <time_frame>perioperative</time_frame>
    <description>Skin temperature was taken before and after skin disinfection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients experience of skin disinfection</measure>
    <time_frame>Perioperative</time_frame>
    <description>Numerical rating scale, 0-10 (0=pleasant-10=unpleasant)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">220</enrollment>
  <condition>Colonization</condition>
  <arm_group>
    <arm_group_label>Preheated chlorhexidine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preheated skin disinfection with 36ᵒC Chlorhexidine 5mg/ml in 70% alcohol.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Room temperature chorhexidine</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Room temperature skin disinfection with 20ᵒC Chlorhexidine 5mg/ml in 70% alcohol.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Preheated</intervention_name>
    <description>Skin disinfection solution is preheated in a warming cupboard</description>
    <arm_group_label>Preheated chlorhexidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  could read and understand Swedish&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infection in existing implanted device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>October 6, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>January 27, 2015</last_update_submitted>
  <last_update_submitted_qc>January 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Örebro University, Sweden</investigator_affiliation>
    <investigator_full_name>Camilla Wistrand</investigator_full_name>
    <investigator_title>Operating room nurse</investigator_title>
  </responsible_party>
  <keyword>skin disinfection</keyword>
  <keyword>bacterial colonization</keyword>
  <keyword>perioperative</keyword>
  <keyword>chlorehexidine</keyword>
  <!-- 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/NCT02260479
org study id: OpPm2013
nct id: NCT02260479
lead sponsor: 
has dmc: No
The primary aim was to investigate if preheated skin disinfection with Chlorhexidine in
      alcohol was non-inferior compared to room-temperature regarding skin colonization as well as
      bacterial colonization in wound, skin temperature and patients experiences.
Patients were randomly assigned to preheated (36ᵒC, intervention) skin disinfection
      (Chlorhexidine 5mg/ml in 70% alcohol) or room temperature (20ᵒC, control) skin disinfection
      (Chlorhexidine 5mg/ml in 70% alcohol). Patient´s enrollment to operation was made by an
      external controller who had no closer knowledge of present study. All patients were asked to
      participate in that sequence they arrived to the OR department when study nurse was present.
      Assignment took place directly after patients consent. Patients were stratified into gender
      and thereafter randomly allocated to preheated or control group, based on a
      computer-generated randomization list made by an independent statistician. Patients showered,
      scrubbing their whole body and hair twice with 4% chlorhexidine soap Descutan® (Fresenius
      Kabi AB, Uppsala, Sweden) prior to surgery. and patients were prepared after skin
      disinfection with a microbial sealant. Most patients were elective and arrived the morning of
      surgery to the hospital. Following standard procedures, intravenously administered antibiotic
      prophylaxis (cloxacillin 2 g) was administrated at the ward 30 minutes before surgery. In the
      OR the patients wore a disposable cap and were positioned on the operating table. The OR
      temperature were 19°C with upward displacement ventilation. Sterile disposable surgical gowns
      (Samutprakarn, Thailand/Mölnlycke Health Care AB, Göteborg, Sweden) and indicator gloves
      (Selangor, Malaysia/Mölnlycke Health Care AB Göteborg, Sweden) were worn by the surgeon and
      OR nurse. Other OR staff (n=2) wore cotton scrubs, short-sleeved tunic shirt with cuffs at
      the arms, and trousers with cuffs at the ankles. They also wore disposable helmets and
      facemasks. Both groups were given skin disinfection during 2 minutes with the same amount of
      solution (Chlorhexidine 5mg/ml in 70% alcohol). The skin disinfection (Chlorhexidine 5mg/ml,
      in alcohol) was stored in room-temperature and was measured to keep 20ᵒC while the preheated
      was stored in a warming cupboard who kept 36ᵒC. The participants were disinfected from cheek
      down over sternum according to routine procedures. Sterile material for draping and clothing
      were for single use only. Cultures were obtained at four occasions using a nylon flocked swab
      (Copan ESwab, Italia SpA): before skin disinfection on skin surface; after skin disinfection
      on skin surface; directly after the incision, at completion of the incision, and finally
      before start of closing sutures. Swab cultures were rubbed for 15 seconds slightly moist with
      saline on skin surface (incision site). Swabs taken in the wound were rubbed along the inside
      of the incision for 15 seconds with a dry swab. Surgery was performed by two cardiologists.
      Cultures were kept cold until arrival at the Department of Laboratory medicine, Clinical
      Microbiology. Cultures were taken care of and analyzed according to a specific protocol
      designed especially for the study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Bacterial cultures
time frame: perioperative
description: Skin cultures (eSwab) taken before and after skin disinfection
measure: Surgical site infections
time frame: Three month after surgery
measure: bacterial colonization in wound
time frame: perioperative
description: Cultures taken in wound at time for incision and before closing sutures
measure: Skin temperature
time frame: perioperative
description: Skin temperature was taken before and after skin disinfection
measure: Patients experience of skin disinfection
time frame: Perioperative
description: Numerical rating scale, 0-10 (0=pleasant-10=unpleasant)
arm group label: Preheated chlorhexidine
arm group type: Active Comparator
description: Preheated skin disinfection with 36ᵒC Chlorhexidine 5mg/ml in 70% alcohol.
arm group label: Room temperature chorhexidine
arm group type: No Intervention
description: Room temperature skin disinfection with 20ᵒC Chlorhexidine 5mg/ml in 70% alcohol.
intervention type: Procedure
intervention name: Preheated
description: Skin disinfection solution is preheated in a warming cupboard
arm group label: Preheated chlorhexidine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Örebro University, Sweden
investigator full name: Camilla Wistrand
investigator title: Operating room nurse