<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/NCT03250442</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0599</org_study_id>
    <nct_id>NCT03250442</nct_id>
  </id_info>
  <brief_title>Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Amputations</brief_title>
  <official_title>A Randomized Controlled Trial Evaluating the Outcomes for Incisional Application of Negative Pressure for Nontraumatic Lower Extremity Amputations: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Georgetown University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Georgetown University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate how well subjects heal after surgery who receive&#xD;
      standard dressings or incisional negative pressure wound therapy for non-traumatic amputation&#xD;
      sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Incisional negative pressure wound therapy is an approved device used for wound healing of&#xD;
      closed surgical incisions. This research is being done because incisional negative pressure&#xD;
      wound therapy is a new application of negative pressure wound therapy that is applied over a&#xD;
      closed incision area instead of an open wound. Negative pressure wound therapy is commonly&#xD;
      used to help heal open wounds. It involves the use of a piece of foam, an adhesive drape, and&#xD;
      a battery-powered device that places negative pressure on the wound. Currently, there are no&#xD;
      trials utilizing incisional negative pressure wound therapy of closed wounds after below knee&#xD;
      amputations (BKA), transmetatarsal amputations (TMA), Knee Disarticulations (KD), and Above&#xD;
      Knee Amputations (AKA). This is a pilot study that compares incisional negative pressure&#xD;
      wound therapy and standard dressings in patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of postoperative incision complications between the 2 arms</measure>
    <time_frame>95 days</time_frame>
    <description>The proportion of issues that arise between the two groups after closure surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>5 days</time_frame>
    <description>The amount of time the patients must stay after closure surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of surgically related wound readmissions</measure>
    <time_frame>95 days</time_frame>
    <description>The number of times patients are readmitted to the hospital for their surgical wound post-discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical Outcomes Study 12 Short Form Health Survey (SF-12)</measure>
    <time_frame>95 days</time_frame>
    <description>Change in quality of life from the start of the study to the end.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge</measure>
    <time_frame>At 1, 2, and 3 months post-hospital discharge</time_frame>
    <description>The percentage of closed surgical wounds that remain closed after 1, 2 and 3 months after their closure surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">112</enrollment>
  <condition>Surgical Wound</condition>
  <condition>Wound Heal</condition>
  <condition>Amputation</condition>
  <arm_group>
    <arm_group_label>Group A: Standard Dry Dressing</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Foam, Drape, and PrevenaTM</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PrevenaTM Device</intervention_name>
    <description>The PrevenaTM Incision Management System covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.</description>
    <arm_group_label>Group B: Foam, Drape, and PrevenaTM</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Dry Dressing</intervention_name>
    <description>These are customary dry dressings.</description>
    <arm_group_label>Group A: Standard Dry Dressing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Must be at least 18 years or older to participate.&#xD;
&#xD;
          2. Requires closure of a nontrauamtic Transmetatarsal Amputation (TMA), Below Knee&#xD;
             Amputation (BKA), Knee Disarticulation (KD), or Above Knee Amputation (AKA).&#xD;
&#xD;
          3. Has at least one artery that feeds the closure site.&#xD;
&#xD;
          4. Able to comply with clinical trial procedures and schedule.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients not receiving an amputation.&#xD;
&#xD;
          2. The investigator/provider determines that the patient has an indication against&#xD;
             incisional negative pressure wound therapy that would prevent them from participating.&#xD;
&#xD;
          3. Surgical incision that is not completely closed.&#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>Christopher Attinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MedStar Georgetown University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christopher Attinger, MD</last_name>
    <phone>202-444-8780</phone>
    <email>christopher.attinger@medstar.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medstar Georgetown University Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paul Kim, DPM</last_name>
      <phone>202-444-3059</phone>
    </contact>
    <investigator>
      <last_name>Paul Kim, DPM</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>August 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Georgetown University</investigator_affiliation>
    <investigator_full_name>Christopher Attinger, M.D.</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03250442
org study id: 2017-0599
nct id: NCT03250442
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
The purpose of this study is to evaluate how well subjects heal after surgery who receive
      standard dressings or incisional negative pressure wound therapy for non-traumatic amputation
      sites.
Incisional negative pressure wound therapy is an approved device used for wound healing of
      closed surgical incisions. This research is being done because incisional negative pressure
      wound therapy is a new application of negative pressure wound therapy that is applied over a
      closed incision area instead of an open wound. Negative pressure wound therapy is commonly
      used to help heal open wounds. It involves the use of a piece of foam, an adhesive drape, and
      a battery-powered device that places negative pressure on the wound. Currently, there are no
      trials utilizing incisional negative pressure wound therapy of closed wounds after below knee
      amputations (BKA), transmetatarsal amputations (TMA), Knee Disarticulations (KD), and Above
      Knee Amputations (AKA). This is a pilot study that compares incisional negative pressure
      wound therapy and standard dressings in patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of postoperative incision complications between the 2 arms
time frame: 95 days
description: The proportion of issues that arise between the two groups after closure surgery.
measure: Length of hospital stay
time frame: 5 days
description: The amount of time the patients must stay after closure surgery.
measure: Number of surgically related wound readmissions
time frame: 95 days
description: The number of times patients are readmitted to the hospital for their surgical wound post-discharge.
measure: Medical Outcomes Study 12 Short Form Health Survey (SF-12)
time frame: 95 days
description: Change in quality of life from the start of the study to the end.
measure: Percentage of closed incisions remained closed at 1, 2 and 3 months post-hospital discharge
time frame: At 1, 2, and 3 months post-hospital discharge
description: The percentage of closed surgical wounds that remain closed after 1, 2 and 3 months after their closure surgery.
arm group label: Group A: Standard Dry Dressing
arm group type: Other
description: The standard dry dressing is comprised of nonadherent dressing, dry gauze, cotton undercast padding, compression, and immobilization.
arm group label: Group B: Foam, Drape, and PrevenaTM
arm group type: Active Comparator
description: This arm is comprised of foam, drape, the PrevenaTM Device, compression, and immobilization.
intervention type: Device
intervention name: PrevenaTM Device
description: The PrevenaTM Incision Management System covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.
arm group label: Group B: Foam, Drape, and PrevenaTM
intervention type: Other
intervention name: Standard Dry Dressing
description: These are customary dry dressings.
arm group label: Group A: Standard Dry Dressing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christopher Attinger, MD
role: Principal Investigator
affiliation: MedStar Georgetown University Hospital
last name: Christopher Attinger, MD
phone: 202-444-8780
email: christopher.attinger@medstar.net
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Georgetown University
investigator full name: Christopher Attinger, M.D.
investigator title: Associate Professor
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: No