<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/NCT04462861</url>
  </required_header>
  <id_info>
    <org_study_id>20-1592</org_study_id>
    <nct_id>NCT04462861</nct_id>
  </id_info>
  <brief_title>A New Securement Method for External Tunneled Central Venous Access Devices (CVAD)</brief_title>
  <official_title>A New Securement Method for External Tunneled Central Venous Access Devices (CVAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital Colorado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      An external tunneled central venous access device (CVAD) is a small plastic tube that is&#xD;
      tunneled under the skin into a major vein for long-term use (Figure 1). Patients who require&#xD;
      a tunneled CVAD are some of the sickest patients we encounter and include oncology,&#xD;
      hematology, and gastrointestinal (intestinal failure) patients. These patients are heavily&#xD;
      reliant on their tunneled CVAD, which can be a lifeline for long-term administration of&#xD;
      chemotherapeutics, IV medications, blood product transfusions, antibiotics, enteral&#xD;
      nutrition, blood draws and fluids. Unfortunately, nearly 30% of pediatric external tunneled&#xD;
      CVADs fail prior to the completion of treatment. External tunneled CVAD failures lead to&#xD;
      unnecessary morbidity and mortality, interruption of medical therapy, and the added costs and&#xD;
      risks associated with additional procedural complications. It is hypothesized that a newly&#xD;
      designed securement method for external tunneled central venous access devices (CVAD) will&#xD;
      reduce catheter-related complications and increase patient, parent and provider satisfaction,&#xD;
      compared to the current standard of care, which is a clear transparent film dressing over the&#xD;
      catheter exit site. A 20 patient, prospective clinical trial is proposed to address the&#xD;
      following specific aims, which will determine if the securement device:&#xD;
&#xD;
        1. Is rated by patients, parents and providers as easy to apply and comfortable for users&#xD;
&#xD;
        2. Reduces CVAD-related complications, such as delayed healing of the tract,&#xD;
           catheter-related infections, and episodes of catheter dislodgement&#xD;
&#xD;
        3. Improves the quality of life for patients and their parents&#xD;
&#xD;
        4. Is preferred over the standard, clear transparent dressing alone&#xD;
&#xD;
        5. Requires any design modifications to improve performance and/or comfort of the device&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective pilot trial to examine the feasibility for a new CVAD securement device&#xD;
      prototype (see appendix for computer-aided design drawings). Eligible patients will be&#xD;
      identified by either mid-level providers, consulting services, or attending surgeons.&#xD;
      Researchers will obtain consent from the patient or their parent/legal guardian. Caregivers&#xD;
      will be educated on how to apply the securement device and will be given a number to call&#xD;
      should they have any questions or concerns. Once the patient is enrolled and provided with&#xD;
      the device, the investigators will perform follow up telephone interviews at one and three&#xD;
      weeks to evaluate their experience and ensure they did not experience any adverse events.&#xD;
&#xD;
      The investigators will prospectively record the primary and secondary outcomes regarding use&#xD;
      of the securement device, including: comfort, quality of materials, adhesive, ease of use,&#xD;
      skin problems, infections, dislodgement episodes, catheter breakage, types and numbers of&#xD;
      interactions with healthcare providers (phone calls, emergency department and clinic visits),&#xD;
      perceived safety, and overall impressions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 19, 2020</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comfort</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of materials</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of Adhesive</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ease of use</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of satisfaction</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin irritation</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of complication, if applicable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Infection</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of complication, if applicable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>dislodgement</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of complication, if applicable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>catheter breakage</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of complication, if applicable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>types and numbers of interactions with healthcare providers</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of interaction, if applicable</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived safety</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of perceived device safety</description>
  </primary_outcome>
  <primary_outcome>
    <measure>overall impression</measure>
    <time_frame>3 weeks</time_frame>
    <description>Survey question asking for qualitative description of overall impression of device</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Central Venous Catheter Exit Site Infection</condition>
  <condition>Central Venous Catheter Related Bloodstream Infection</condition>
  <arm_group>
    <arm_group_label>CVAD securement device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with a pre-existing CVAD who will trial the new securement dressing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Central venous access device (CVAD) Snuggie Securement Device</intervention_name>
    <description>Participants will be given a prototype of a CVAD securement device for a three week trial. Descriptive data relating to user satisfaction will be collected at 1 and 3 weeks</description>
    <arm_group_label>CVAD securement device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 31 days to 18 years old, who will undergo surgical placement of a&#xD;
             tunneled CVAD&#xD;
&#xD;
          -  Any patient with a pre-existing CVAD, who presents to the surgery clinic, emergency&#xD;
             department, or is seen as an inpatient consult relating to complications associated&#xD;
             with their CVAD&#xD;
&#xD;
          -  Patients admitted to the hospital with a pre-existing CVAD for reasons unrelated to&#xD;
             the CVAD will be eligible for the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any assenting child or consenting parent/guardian can at any time refuse to&#xD;
             participate in the study and will be removed&#xD;
&#xD;
          -  Any patient whose parents or legal guardians cannot be reached in person or by&#xD;
             telephone to provide consent&#xD;
&#xD;
          -  Any prisoners, pregnant women, or person with impaired decision-making capacity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>31 Days</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven L Moulton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Colorado</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jenny Stevens, MD</last_name>
    <phone>2515899950</phone>
    <email>jenny.stevens@childrenscolorado.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marina Reppucci, MD</last_name>
    <phone>2037314914</phone>
    <email>marina.reppucci@childrenscolorado.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>54008</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Reppucci, MD</last_name>
      <phone>203-731-4914</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.</citation>
    <PMID>26459655</PMID>
  </reference>
  <reference>
    <citation>Ullman AJ, Cooke M, Rickard C. Examining the role of securement and dressing products to prevent central venous access device failure: a narrative review J Assoc Vasc Access 2015; 20:99-110</citation>
  </reference>
  <reference>
    <citation>Frey AM, Schears GJ. Why are we stuck on tape and suture? A review of catheter securement devices. J Infus Nurs. 2006 Jan-Feb;29(1):34-8. doi: 10.1097/00129804-200601000-00007.</citation>
    <PMID>16428999</PMID>
  </reference>
  <reference>
    <citation>Orgel E, Ji L, Pastor W, Schore RJ. Infectious morbidity by catheter type in neutropenic children with cancer. Pediatr Infect Dis J. 2014 Mar;33(3):263-6. doi: 10.1097/INF.0000000000000060.</citation>
    <PMID>24263218</PMID>
  </reference>
  <reference>
    <citation>Brandt B, DePalma J, Irwin M, Shogan J, Lucke JF. Comparison of central venous catheter dressings in bone marrow transplant recipients. Oncol Nurs Forum. 1996 Jun;23(5):829-36.</citation>
    <PMID>8792352</PMID>
  </reference>
  <reference>
    <citation>Shivnan JC, McGuire D, Freedman S, Sharkazy E, Bosserman G, Larson E, Grouleff P. A comparison of transparent adherent and dry sterile gauze dressings for long-term central catheters in patients undergoing bone marrow transplant. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1349-56.</citation>
    <PMID>1762975</PMID>
  </reference>
  <reference>
    <citation>Chambers ST, Sanders J, Patton WN, Ganly P, Birch M, Crump JA, Spearing RL. Reduction of exit-site infections of tunnelled intravascular catheters among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial. J Hosp Infect. 2005 Sep;61(1):53-61. doi: 10.1016/j.jhin.2005.01.023.</citation>
    <PMID>16002181</PMID>
  </reference>
  <reference>
    <citation>Ruschulte H, Franke M, Gastmeier P, Zenz S, Mahr KH, Buchholz S, Hertenstein B, Hecker H, Piepenbrock S. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009 Mar;88(3):267-72. doi: 10.1007/s00277-008-0568-7. Epub 2008 Aug 5.</citation>
    <PMID>18679683</PMID>
  </reference>
  <reference>
    <citation>Ullman AJ, Kleidon T, Gibson V, McBride CA, Mihala G, Cooke M, Rickard CM. Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial. BMC Cancer. 2017 Aug 30;17(1):595. doi: 10.1186/s12885-017-3606-9.</citation>
    <PMID>28854967</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>June 13, 2023</last_update_submitted>
  <last_update_submitted_qc>June 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>central venous access device, CVAD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Sepsis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available to other researchers</ipd_description>
  </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/NCT04462861
org study id: 20-1592
nct id: NCT04462861
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
An external tunneled central venous access device (CVAD) is a small plastic tube that is
      tunneled under the skin into a major vein for long-term use (Figure 1). Patients who require
      a tunneled CVAD are some of the sickest patients we encounter and include oncology,
      hematology, and gastrointestinal (intestinal failure) patients. These patients are heavily
      reliant on their tunneled CVAD, which can be a lifeline for long-term administration of
      chemotherapeutics, IV medications, blood product transfusions, antibiotics, enteral
      nutrition, blood draws and fluids. Unfortunately, nearly 30% of pediatric external tunneled
      CVADs fail prior to the completion of treatment. External tunneled CVAD failures lead to
      unnecessary morbidity and mortality, interruption of medical therapy, and the added costs and
      risks associated with additional procedural complications. It is hypothesized that a newly
      designed securement method for external tunneled central venous access devices (CVAD) will
      reduce catheter-related complications and increase patient, parent and provider satisfaction,
      compared to the current standard of care, which is a clear transparent film dressing over the
      catheter exit site. A 20 patient, prospective clinical trial is proposed to address the
      following specific aims, which will determine if the securement device:

        1. Is rated by patients, parents and providers as easy to apply and comfortable for users

        2. Reduces CVAD-related complications, such as delayed healing of the tract,
           catheter-related infections, and episodes of catheter dislodgement

        3. Improves the quality of life for patients and their parents

        4. Is preferred over the standard, clear transparent dressing alone

        5. Requires any design modifications to improve performance and/or comfort of the device
A prospective pilot trial to examine the feasibility for a new CVAD securement device
      prototype (see appendix for computer-aided design drawings). Eligible patients will be
      identified by either mid-level providers, consulting services, or attending surgeons.
      Researchers will obtain consent from the patient or their parent/legal guardian. Caregivers
      will be educated on how to apply the securement device and will be given a number to call
      should they have any questions or concerns. Once the patient is enrolled and provided with
      the device, the investigators will perform follow up telephone interviews at one and three
      weeks to evaluate their experience and ensure they did not experience any adverse events.

      The investigators will prospectively record the primary and secondary outcomes regarding use
      of the securement device, including: comfort, quality of materials, adhesive, ease of use,
      skin problems, infections, dislodgement episodes, catheter breakage, types and numbers of
      interactions with healthcare providers (phone calls, emergency department and clinic visits),
      perceived safety, and overall impressions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Comfort
time frame: 3 weeks
description: Survey question asking for qualitative description of satisfaction
measure: quality of materials
time frame: 3 weeks
description: Survey question asking for qualitative description of satisfaction
measure: Quality of Adhesive
time frame: 3 weeks
description: Survey question asking for qualitative description of satisfaction
measure: Ease of use
time frame: 3 weeks
description: Survey question asking for qualitative description of satisfaction
measure: Skin irritation
time frame: 3 weeks
description: Survey question asking for qualitative description of complication, if applicable
measure: Infection
time frame: 3 weeks
description: Survey question asking for qualitative description of complication, if applicable
measure: dislodgement
time frame: 3 weeks
description: Survey question asking for qualitative description of complication, if applicable
measure: catheter breakage
time frame: 3 weeks
description: Survey question asking for qualitative description of complication, if applicable
measure: types and numbers of interactions with healthcare providers
time frame: 3 weeks
description: Survey question asking for qualitative description of interaction, if applicable
measure: Perceived safety
time frame: 3 weeks
description: Survey question asking for qualitative description of perceived device safety
measure: overall impression
time frame: 3 weeks
description: Survey question asking for qualitative description of overall impression of device
arm group label: CVAD securement device
arm group type: Experimental
description: Patients with a pre-existing CVAD who will trial the new securement dressing
intervention type: Device
intervention name: Central venous access device (CVAD) Snuggie Securement Device
description: Participants will be given a prototype of a CVAD securement device for a three week trial. Descriptive data relating to user satisfaction will be collected at 1 and 3 weeks
arm group label: CVAD securement device
criteria: 
gender: All
minimum age: 31 Days
maximum age: 18 Years
healthy volunteers: No
last name: Steven L Moulton, MD
role: Principal Investigator
affiliation: Children's Hospital Colorado
last name: Jenny Stevens, MD
phone: 2515899950
email: jenny.stevens@childrenscolorado.org
last name: Marina Reppucci, MD
phone: 2037314914
email: marina.reppucci@childrenscolorado.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.
PMID: 26459655
citation: Ullman AJ, Cooke M, Rickard C. Examining the role of securement and dressing products to prevent central venous access device failure: a narrative review J Assoc Vasc Access 2015; 20:99-110
citation: Frey AM, Schears GJ. Why are we stuck on tape and suture? A review of catheter securement devices. J Infus Nurs. 2006 Jan-Feb;29(1):34-8. doi: 10.1097/00129804-200601000-00007.
PMID: 16428999
citation: Orgel E, Ji L, Pastor W, Schore RJ. Infectious morbidity by catheter type in neutropenic children with cancer. Pediatr Infect Dis J. 2014 Mar;33(3):263-6. doi: 10.1097/INF.0000000000000060.
PMID: 24263218
citation: Brandt B, DePalma J, Irwin M, Shogan J, Lucke JF. Comparison of central venous catheter dressings in bone marrow transplant recipients. Oncol Nurs Forum. 1996 Jun;23(5):829-36.
PMID: 8792352
citation: Shivnan JC, McGuire D, Freedman S, Sharkazy E, Bosserman G, Larson E, Grouleff P. A comparison of transparent adherent and dry sterile gauze dressings for long-term central catheters in patients undergoing bone marrow transplant. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1349-56.
PMID: 1762975
citation: Chambers ST, Sanders J, Patton WN, Ganly P, Birch M, Crump JA, Spearing RL. Reduction of exit-site infections of tunnelled intravascular catheters among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial. J Hosp Infect. 2005 Sep;61(1):53-61. doi: 10.1016/j.jhin.2005.01.023.
PMID: 16002181
citation: Ruschulte H, Franke M, Gastmeier P, Zenz S, Mahr KH, Buchholz S, Hertenstein B, Hecker H, Piepenbrock S. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009 Mar;88(3):267-72. doi: 10.1007/s00277-008-0568-7. Epub 2008 Aug 5.
PMID: 18679683
citation: Ullman AJ, Kleidon T, Gibson V, McBride CA, Mihala G, Cooke M, Rickard CM. Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial. BMC Cancer. 2017 Aug 30;17(1):595. doi: 10.1186/s12885-017-3606-9.
PMID: 28854967
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Sepsis
sharing ipd: No
ipd description: There is no plan to make individual participant data available to other researchers