<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/NCT01680367</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-06043</org_study_id>
    <secondary_id>NCI-2012-00985</secondary_id>
    <nct_id>NCT01680367</nct_id>
  </id_info>
  <brief_title>Wound Dressings For Split-Thickness Skin Graft Donor Sites in Patients Undergoing Surgery</brief_title>
  <official_title>A Comparative Study of Dressings for Split-Thickness Skin Graft Donor Sites.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is to determine what dressing would work best to heal and keep from hurting, the&#xD;
      split-thickness skin graft donor site which will be done as part of the patient's surgical&#xD;
      procedure. Currently there is a dressing that is transparent and it is placed on the wound&#xD;
      after surgery and wrapped with gauze and an elastic bandage. Two days after the surgery the&#xD;
      gauze and elastic bandages are removed and the area is left with the transparent dressing.&#xD;
      Sometimes the dressing needs to be changed because it leaks. On the fifth day this dressing&#xD;
      is removed and the wound is left open to air. The dressing researchers are studying is a&#xD;
      dressing that has been used for different types of wounds, as well as this type of wound. It&#xD;
      is applied in the same manner; however, it is left in place until it falls off independently,&#xD;
      usually around post-operative (post-op) day 10.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Which dressing type and technique is most effective in minimizing pain and inflammation&#xD;
      and promoting epithelialization in patients who have had surgery which requires the use of an&#xD;
      anterior thigh split-thickness skin graft?&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive transparent film dressing (otolaryngology service) or Xeroform&#xD;
      petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.&#xD;
&#xD;
      ARM II: Patients receive native collagen wound dressing after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2008</start_date>
  <completion_date type="Actual">July 2010</completion_date>
  <primary_completion_date type="Actual">July 2010</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score ranging in value from 0 to 10</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Initial analyses will include two sample t-tests (or a nonparametric equivalent, if more appropriate) for each day to compare the mean pain scores for each treatment group. The pain score will be evaluated using multiple linear regression, while multiple logistic or polytomous regression will be used for the categorical outcomes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Distress checklist score</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>The specific modeling approach for the distress score will depend on the range of values obtained. Standard model building techniques will be employed and clinically important interactions between covariates and the groups will be explored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation as measured by the Wound Assessment Inventory (WAI)</measure>
    <time_frame>Up to 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Categorical epithelialization assessment</measure>
    <time_frame>Up to 14 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Pain</condition>
  <condition>Perioperative/Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Arm I (control)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (native collagen wound dressing)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive native collagen wound dressing after surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>wound care management</intervention_name>
    <description>Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing</description>
    <arm_group_label>Arm I (control)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>wound care management</intervention_name>
    <description>Receive native collagen wound dressing</description>
    <arm_group_label>Arm II (native collagen wound dressing)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (control)</arm_group_label>
    <arm_group_label>Arm II (native collagen wound dressing)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Population of otolaryngological or surgical oncology patients experiencing an&#xD;
             autologous split-thickness skin graft as part of their surgical procedure&#xD;
&#xD;
          -  Patients will have a Glasgow Coma score of 15 (or 10 with a tracheostomy)&#xD;
&#xD;
          -  Patient donor sites will be limited to the anterior thigh&#xD;
&#xD;
          -  Patients will be free of documented circulatory deficits, neuropathy, or mental&#xD;
             illness which prohibits their ability to independently consent or respond to questions&#xD;
             regarding pain&#xD;
&#xD;
          -  Patients will be able to give consent independently&#xD;
&#xD;
          -  Patients will be able to read and write in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to give independent consent for any reason&#xD;
&#xD;
          -  Skin graft donor sites other than the anterior thigh&#xD;
&#xD;
          -  Patients with a concurrent diagnosis of diabetes, peripheral vascular disease, and/or&#xD;
             paresthesias or paralysis of the lower extremities&#xD;
&#xD;
          -  Patients who are unable to complete a self-report pain scale&#xD;
&#xD;
          -  Patients who are prisoners&#xD;
&#xD;
          -  Patients who are known active alcoholics&#xD;
&#xD;
          -  Patients on steroids or other medications known to affect healing&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Hofacre</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>The Jamesline</description>
  </link>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>March 16, 2016</last_update_submitted>
  <last_update_submitted_qc>March 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_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/NCT01680367
org study id: OSU-06043
secondary id: NCI-2012-00985
nct id: NCT01680367
lead sponsor: 
has dmc: Yes
This study is to determine what dressing would work best to heal and keep from hurting, the
      split-thickness skin graft donor site which will be done as part of the patient's surgical
      procedure. Currently there is a dressing that is transparent and it is placed on the wound
      after surgery and wrapped with gauze and an elastic bandage. Two days after the surgery the
      gauze and elastic bandages are removed and the area is left with the transparent dressing.
      Sometimes the dressing needs to be changed because it leaks. On the fifth day this dressing
      is removed and the wound is left open to air. The dressing researchers are studying is a
      dressing that has been used for different types of wounds, as well as this type of wound. It
      is applied in the same manner; however, it is left in place until it falls off independently,
      usually around post-operative (post-op) day 10.
PRIMARY OBJECTIVES:

      I. Which dressing type and technique is most effective in minimizing pain and inflammation
      and promoting epithelialization in patients who have had surgery which requires the use of an
      anterior thigh split-thickness skin graft?

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive transparent film dressing (otolaryngology service) or Xeroform
      petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.

      ARM II: Patients receive native collagen wound dressing after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain score ranging in value from 0 to 10
time frame: Up to 14 days
description: Initial analyses will include two sample t-tests (or a nonparametric equivalent, if more appropriate) for each day to compare the mean pain scores for each treatment group. The pain score will be evaluated using multiple linear regression, while multiple logistic or polytomous regression will be used for the categorical outcomes.
measure: Distress checklist score
time frame: Up to 14 days
description: The specific modeling approach for the distress score will depend on the range of values obtained. Standard model building techniques will be employed and clinically important interactions between covariates and the groups will be explored.
measure: Inflammation as measured by the Wound Assessment Inventory (WAI)
time frame: Up to 14 days
measure: Categorical epithelialization assessment
time frame: Up to 14 days
arm group label: Arm I (control)
arm group type: Experimental
description: Patients receive transparent film dressing (otolaryngology service) or Xeroform petroleum gel impregnated gauze dressing (surgical oncology service) after surgery.
arm group label: Arm II (native collagen wound dressing)
arm group type: Experimental
description: Patients receive native collagen wound dressing after surgery.
intervention type: Procedure
intervention name: wound care management
description: Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing
arm group label: Arm I (control)
intervention type: Procedure
intervention name: wound care management
description: Receive native collagen wound dressing
arm group label: Arm II (native collagen wound dressing)
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Arm I (control)
arm group label: Arm II (native collagen wound dressing)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert Hofacre
role: Principal Investigator
affiliation: Ohio State University
facility: 
country: United States
url: http://cancer.osu.edu
description: The Jamesline
responsible party type: Sponsor
mesh term: Postoperative Complications