<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/NCT02253069</url>
  </required_header>
  <id_info>
    <org_study_id>Regionskane</org_study_id>
    <nct_id>NCT02253069</nct_id>
  </id_info>
  <brief_title>PHMB-based Antiseptic Use in Full-thickness Surgical Wounds</brief_title>
  <official_title>A Study of Polyhexanide-based Antiseptic in Full-thickness Surgical Wounds in Dermatologic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Vinnova</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the effect of applying a PHMB-based antiseptic solution to tie-over dressings in&#xD;
      full-thickness surgical wounds in dermatologic surgery in order to minimise the development&#xD;
      of surgical site infections. The bacterial dynamics in wounds pre-,intra-, and&#xD;
      postoperatively will be examined in order to understand the pathogenesis of surgical site&#xD;
      infections better.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      40 patients with suspected skin cancer in the face planned for full-thickness surgery will be&#xD;
      randomised into two groups: One will receive a traditional tie-over dressing saturated with&#xD;
      NaCl and the other group will receive a tie-over dressing saturated with a PHMB-based&#xD;
      antiseptic. A quantitative and qualitative bacterial analysis of wounds by using a modified&#xD;
      Levine's swabbing technique will be carried out pre-,intra-,and postoperatively. The effect&#xD;
      of nasal colonisation with S.aureus on the development of surgical site infections will be&#xD;
      investigated. All wounds will be followed a week after surgery to assess development of&#xD;
      infections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measuring colony forming units in swabs collected from wounds pre-,intra- and postoperatively (7 days after surgery1). Change in bacterial load will be attributed to the effect of applying an antiseptic solution to wound dressings.</measure>
    <time_frame>7 days</time_frame>
    <description>Wounds will be swabbed at end of surgery and then 7 days after surgery. Number and type of bacteria present will be analysed. Our hypothesis is that applying the antiseptic solution to the tie-over dressings will show a suppressed growth of bacteria when measured 7 days after surgery.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Surgical Site Infections</condition>
  <arm_group>
    <arm_group_label>PHMB-based antiseptic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Applying Prontosan antiseptic solution to tie-over dressings</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Applying water to tie-over dressings</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Applying Prontosan antiseptic solution to tie-over dressings</intervention_name>
    <description>Applying a PHMB-based antiseptic to tie-over dressings</description>
    <arm_group_label>PHMB-based antiseptic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Applying Placebo to tie-over dressings</intervention_name>
    <description>Placebo control</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients planned for full-thickness skin grafting in the face&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with no diabetes&#xD;
&#xD;
          -  Patients with no current/previous/recent antibiotic therapy&#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>Karim Saleh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Dermatology, Skåne University Hospital, Lund</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of dermatology, Skåne university hospital</name>
      <address>
        <city>Lund</city>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Saleh K, Sonesson A, Persson B, Riesbeck K, Schmidtchen A. A descriptive study of bacterial load of full-thickness surgical wounds in dermatologic surgery. Dermatol Surg. 2011 Jul;37(7):1014-22. doi: 10.1111/j.1524-4725.2011.02040.x. Epub 2011 May 25.</citation>
    <PMID>21615603</PMID>
  </reference>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>December 8, 2015</last_update_submitted>
  <last_update_submitted_qc>December 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Skane</investigator_affiliation>
    <investigator_full_name>Karim Saleh</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Infective Agents, Local</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02253069
org study id: Regionskane
nct id: NCT02253069
lead sponsor: 
collaborator: 
has dmc: Yes
To study the effect of applying a PHMB-based antiseptic solution to tie-over dressings in
      full-thickness surgical wounds in dermatologic surgery in order to minimise the development
      of surgical site infections. The bacterial dynamics in wounds pre-,intra-, and
      postoperatively will be examined in order to understand the pathogenesis of surgical site
      infections better.
40 patients with suspected skin cancer in the face planned for full-thickness surgery will be
      randomised into two groups: One will receive a traditional tie-over dressing saturated with
      NaCl and the other group will receive a tie-over dressing saturated with a PHMB-based
      antiseptic. A quantitative and qualitative bacterial analysis of wounds by using a modified
      Levine's swabbing technique will be carried out pre-,intra-,and postoperatively. The effect
      of nasal colonisation with S.aureus on the development of surgical site infections will be
      investigated. All wounds will be followed a week after surgery to assess development of
      infections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Measuring colony forming units in swabs collected from wounds pre-,intra- and postoperatively (7 days after surgery1). Change in bacterial load will be attributed to the effect of applying an antiseptic solution to wound dressings.
time frame: 7 days
description: Wounds will be swabbed at end of surgery and then 7 days after surgery. Number and type of bacteria present will be analysed. Our hypothesis is that applying the antiseptic solution to the tie-over dressings will show a suppressed growth of bacteria when measured 7 days after surgery.
arm group label: PHMB-based antiseptic
arm group type: Experimental
description: Applying Prontosan antiseptic solution to tie-over dressings
arm group label: Control
arm group type: Placebo Comparator
description: Applying water to tie-over dressings
intervention type: Device
intervention name: Applying Prontosan antiseptic solution to tie-over dressings
description: Applying a PHMB-based antiseptic to tie-over dressings
arm group label: PHMB-based antiseptic
intervention type: Device
intervention name: Applying Placebo to tie-over dressings
description: Placebo control
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Karim Saleh, MD
role: Principal Investigator
affiliation: Department of Dermatology, Skåne University Hospital, Lund
facility: 
country: Sweden
citation: Saleh K, Sonesson A, Persson B, Riesbeck K, Schmidtchen A. A descriptive study of bacterial load of full-thickness surgical wounds in dermatologic surgery. Dermatol Surg. 2011 Jul;37(7):1014-22. doi: 10.1111/j.1524-4725.2011.02040.x. Epub 2011 May 25.
PMID: 21615603
responsible party type: Principal Investigator
investigator affiliation: Region Skane
investigator full name: Karim Saleh
investigator title: Dr.
mesh term: Surgical Wound Infection
mesh term: Surgical Wound
mesh term: Anti-Infective Agents, Local