<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/NCT02198066</url>
  </required_header>
  <id_info>
    <org_study_id>CC-2014-1</org_study_id>
    <nct_id>NCT02198066</nct_id>
  </id_info>
  <brief_title>A Comparison of Post-Sternotomy Dressings</brief_title>
  <official_title>A Comparison of Post-Sternotomy Dressings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Carilion Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DeRoyal Industries, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Smith &amp; Nephew, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Carilion Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to determine which of three types of dressings, a dry sterile&#xD;
      dressing, a metallic silver dressing or an ionic silver dressing provided better patient&#xD;
      outcomes for the post-sternotomy cardiac surgery patient population. In this prospective,&#xD;
      randomized controlled trial, the hypothesis was that subjects who received either of the&#xD;
      silver impregnated dressings would have better outcomes (better wound healing, less&#xD;
      discomfort, and less incidence of infection). Investigators also evaluated dressing factors&#xD;
      such as adherence, time for application and ease of use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      No other information included.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">August 2012</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>Wound Healing</measure>
    <time_frame>5 days postoperatively or day of discharge, whichever came first</time_frame>
    <description>The primary outcome measure in this study was wound healing, defined as the degree of wound approximation, skin integrity, exudate, and presence/absence of necrotic tissue, assessed at postoperative day 5 or day of discharge. Wound approximation was assessed as total, partial (less than 2 centimeters of superficial separation), moderate (greater than 2 centimeters of superficial separation), or dehisced (complete separation of layers). Skin integrity was evaluated as normal (pink, no redness), inflamed, (heat, redness, swelling), or macerated within a 2.5 centimeter border of the incision. Exudate quality was assessed as purulent, blood, serosanguinous, or serous. Presence or absence of necrotic tissue was noted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Comfort</measure>
    <time_frame>5 days postoperatively or day of hospital discharge, whichever came first</time_frame>
    <description>The secondary outcome measure in this study was patient comfort with the dressing in place and upon removal. Comfort was measured using a 0-10 scale, with 0 signifying no pain and 10 signifying maximum pain.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Dressing Factors</measure>
    <time_frame>5 days postoperatively or at day of discharge, whichever came first</time_frame>
    <description>Dressing factors of ease of application, removal, and incision assessment were measured on a 5-point Likert-type scale (1=very easy, 2=moderately easy, 3=neither easy nor hard, 4=moderately hard, and 5=very hard). Dressing integrity was assessed as suture line exposed, poorly sealed (imperfect covering of the suture line with the potential for organism entry), or well-sealed.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sternal Wound Infection</measure>
    <time_frame>30 days postoperatively</time_frame>
    <description>Investigators evaluated sternal wound infection presence and type (superficial or deep) using Centers for Disease Control/National Healthcare Safety Network surveillance definitions.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">351</enrollment>
  <condition>Impaired Wound Healing</condition>
  <condition>Postoperative Wound Infection-deep</condition>
  <arm_group>
    <arm_group_label>Dry Sterile Dressing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects in this study arm received a dry sterile dressing (Primapore®, Smith &amp; Nephew), a one-piece, peel-and-stick, non-transparent dressing. This dressing is the standard of care at the study facility for this population and was left in place for either 24 to 48 hours.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metallic Silver Dressing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this arm received a metallic silver dressing (Acticoat Post-Op®, Smith &amp; Nephew), a one-piece, peel-and-stick and non-transparent dressing. This dressing is an absorbent postoperative dressing consisting of a nanocrystalline silver-coated polyurethane layer, a white polyurethane foam and an adhesive coated waterproof polyurethane film layer. Acticoat Post-Op may be left in place over a wound for up to 7 days. The manufacturers note that the product should not be used in patients with known silver allergies and that it may cause transient discoloration of the skin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ionic Silver Dressing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this arm received an ionic silver dressing (Dermanet Ag®, DeRoyal), a semi-transparent dressing that includes silver, alginate, and maltodextrin. The dressing was cut to fit the incision and then covered with a transparent dressing (Transseal®, DeRoyal). This dressing should not be used on patients with known sensitivity to alginates (a seaweed based component).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dry Sterile Dressing</intervention_name>
    <description>Described in Arm Description.</description>
    <arm_group_label>Dry Sterile Dressing</arm_group_label>
    <other_name>Primapore (Smith &amp; Nephew)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Metallic Silver Dressing</intervention_name>
    <description>Described in Arm Description.</description>
    <arm_group_label>Metallic Silver Dressing</arm_group_label>
    <other_name>Acticoat Post-Op (Smith &amp; Nephew)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ionic Silver Dressing</intervention_name>
    <description>Described in Arm Description.</description>
    <arm_group_label>Ionic Silver Dressing</arm_group_label>
    <other_name>Dermanet (DeRoyal)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult (at least 21 years of age) inpatients awaiting cardiac surgery or outpatients&#xD;
             seen in the pre-surgical testing area prior to admission for surgery&#xD;
&#xD;
          -  Having surgery at the study setting&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  Able to understand and give consent&#xD;
&#xD;
          -  Had the approval of their cardiothoracic surgeon to participate&#xD;
&#xD;
          -  Had no known sensitivity to silver&#xD;
&#xD;
          -  Had no known sensitivity to alginates&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known sensitivity to silver&#xD;
&#xD;
          -  Known sensitivity to alginates&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cathy D. Jennings, DNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Carilion Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Carilion Roanoke Memorial Hospital</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>March 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sternotomy incision</keyword>
  <keyword>Silver dressing</keyword>
  <keyword>Sternal wound infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wound Infection</mesh_term>
    <mesh_term>Surgical Wound Infection</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT02198066
org study id: CC-2014-1
nct id: NCT02198066
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study was to determine which of three types of dressings, a dry sterile
      dressing, a metallic silver dressing or an ionic silver dressing provided better patient
      outcomes for the post-sternotomy cardiac surgery patient population. In this prospective,
      randomized controlled trial, the hypothesis was that subjects who received either of the
      silver impregnated dressings would have better outcomes (better wound healing, less
      discomfort, and less incidence of infection). Investigators also evaluated dressing factors
      such as adherence, time for application and ease of use.
No other information included.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Wound Healing
time frame: 5 days postoperatively or day of discharge, whichever came first
description: The primary outcome measure in this study was wound healing, defined as the degree of wound approximation, skin integrity, exudate, and presence/absence of necrotic tissue, assessed at postoperative day 5 or day of discharge. Wound approximation was assessed as total, partial (less than 2 centimeters of superficial separation), moderate (greater than 2 centimeters of superficial separation), or dehisced (complete separation of layers). Skin integrity was evaluated as normal (pink, no redness), inflamed, (heat, redness, swelling), or macerated within a 2.5 centimeter border of the incision. Exudate quality was assessed as purulent, blood, serosanguinous, or serous. Presence or absence of necrotic tissue was noted.
measure: Patient Comfort
time frame: 5 days postoperatively or day of hospital discharge, whichever came first
description: The secondary outcome measure in this study was patient comfort with the dressing in place and upon removal. Comfort was measured using a 0-10 scale, with 0 signifying no pain and 10 signifying maximum pain.
measure: Dressing Factors
time frame: 5 days postoperatively or at day of discharge, whichever came first
description: Dressing factors of ease of application, removal, and incision assessment were measured on a 5-point Likert-type scale (1=very easy, 2=moderately easy, 3=neither easy nor hard, 4=moderately hard, and 5=very hard). Dressing integrity was assessed as suture line exposed, poorly sealed (imperfect covering of the suture line with the potential for organism entry), or well-sealed.
measure: Sternal Wound Infection
time frame: 30 days postoperatively
description: Investigators evaluated sternal wound infection presence and type (superficial or deep) using Centers for Disease Control/National Healthcare Safety Network surveillance definitions.
arm group label: Dry Sterile Dressing
arm group type: Other
description: Subjects in this study arm received a dry sterile dressing (Primapore®, Smith & Nephew), a one-piece, peel-and-stick, non-transparent dressing. This dressing is the standard of care at the study facility for this population and was left in place for either 24 to 48 hours.
arm group label: Metallic Silver Dressing
arm group type: Active Comparator
description: Subjects in this arm received a metallic silver dressing (Acticoat Post-Op®, Smith & Nephew), a one-piece, peel-and-stick and non-transparent dressing. This dressing is an absorbent postoperative dressing consisting of a nanocrystalline silver-coated polyurethane layer, a white polyurethane foam and an adhesive coated waterproof polyurethane film layer. Acticoat Post-Op may be left in place over a wound for up to 7 days. The manufacturers note that the product should not be used in patients with known silver allergies and that it may cause transient discoloration of the skin.
arm group label: Ionic Silver Dressing
arm group type: Active Comparator
description: Subjects in this arm received an ionic silver dressing (Dermanet Ag®, DeRoyal), a semi-transparent dressing that includes silver, alginate, and maltodextrin. The dressing was cut to fit the incision and then covered with a transparent dressing (Transseal®, DeRoyal). This dressing should not be used on patients with known sensitivity to alginates (a seaweed based component).
intervention type: Other
intervention name: Dry Sterile Dressing
description: Described in Arm Description.
arm group label: Dry Sterile Dressing
other name: Primapore (Smith & Nephew)
intervention type: Other
intervention name: Metallic Silver Dressing
description: Described in Arm Description.
arm group label: Metallic Silver Dressing
other name: Acticoat Post-Op (Smith & Nephew)
intervention type: Other
intervention name: Ionic Silver Dressing
description: Described in Arm Description.
arm group label: Ionic Silver Dressing
other name: Dermanet (DeRoyal)
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Cathy D. Jennings, DNP
role: Principal Investigator
affiliation: Carilion Clinic
facility: 
country: United States
responsible party type: Sponsor
mesh term: Wound Infection
mesh term: Surgical Wound Infection
mesh term: Wounds and Injuries