<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/NCT03801811</url>
  </required_header>
  <id_info>
    <org_study_id>382/2018/DISP/AOUPR</org_study_id>
    <nct_id>NCT03801811</nct_id>
  </id_info>
  <brief_title>Use of the Skin Glue in the Placement of Central Venous Catheters Port a Catch</brief_title>
  <acronym>Port glue cvc</acronym>
  <official_title>Prospective Observational Study on the Safety and Efficacy of Cyanoacrylate Skin Glues to Reduce the Risk of Complications After Insertion of Totally Implantable Central Venous Catheters Port-a-Cath</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Parma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Parma</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>
      The use of glue as a device in the implantation of central venous catheters has recently been&#xD;
      introduced into European clinical practice, initially with the aim of blocking bleeding at&#xD;
      the point of exit of the PICCs, but at the same time also to close the cutaneous incision&#xD;
      practiced to create the PORT positioning pocket.&#xD;
&#xD;
      It is possible that the surgical incision created for the insertion of the PORT may undergo&#xD;
      complications such as: local bleeding, infections or wounds of the surgical wound.&#xD;
&#xD;
      A solution to this problem could be the application of the cyanoacrylate dermal glue on the&#xD;
      edges of the surgical wound, after intradermal suture. The glue would have the purpose of&#xD;
      sealing the surgical wound so as to immediately seal the skin incision with hemostatic effect&#xD;
      and create a potential barrier against infections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient's informed consent signature for adhesion at the study will be initially requested.&#xD;
      With their acceptance, parameters will be recorded anonymously in the Case Report Form,&#xD;
      identified by a numeric code, until hospital discharge.&#xD;
&#xD;
      The parameters analized will be related to:&#xD;
&#xD;
        -  essential patient data (identification number, gender, age, height weight)&#xD;
&#xD;
        -  basic diseases&#xD;
&#xD;
        -  associated diseases and risk factors&#xD;
&#xD;
        -  origin of the patient (department or home)&#xD;
&#xD;
        -  reason for positioning&#xD;
&#xD;
        -  hemorrhagic complications detected in the first 24 hours&#xD;
&#xD;
        -  hemorrhagic complications detected in the first 7 days&#xD;
&#xD;
        -  non-bleeding complications detected at 7 days (local and systemic infections, wound&#xD;
           delescence)&#xD;
&#xD;
      The data wil be transferred to an Excel worksheet, in order to conduct a descriptive analysis&#xD;
      related to every variable&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 5, 2018</start_date>
  <completion_date type="Anticipated">April 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>visible presence of blood around the emergency site</measure>
    <time_frame>24 hours</time_frame>
    <description>Evaluate the effectiveness of cyanoacrylate glue in reducing / eliminating bleeding local from the insertion site after PORT implantation (evaluated as visible presence of blood around the emergency site.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early infection of the emergency site;</measure>
    <time_frame>7 days</time_frame>
    <description>Rate of early infection of the emergency site; Early infection of the emergency site is assessed by observing skin changes as the presence of: pain, hot skin and reddened skin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Deischence of the surgical wound</measure>
    <time_frame>15 days</time_frame>
    <description>Rate of dehiscence of the surgical wound. This will be assessed by looking for signs of bleeding, pain, fever and inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic infection</measure>
    <time_frame>15 days</time_frame>
    <description>Rate of systemic infections will be evaluated by evaluating the presence of fever</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Central Venous Catheter</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Study of the efficacy of using skin glue in the application of Port a cath</intervention_name>
    <description>The use of glue as a device in the implantation of central venous catheters has recently been introduced into European clinical practice. It is possible that the surgical incision created for the insertion of the PORT may be subject to complications such as: local bleeding, which if not properly treated may last even a few days, infections or surgical wound outbreaks. This possibility of bleeding occurs more easily in patients suffering from coagulation problems or when appropriate preventive measures have not been taken at the time of implantation of the device. A solution to this problem could be the application of the cyanoacrylate dermal glue on the edges of the surgical wound, after intradermal suture. The glue would have the purpose of sealing the surgical wound so as to immediately seal the skin incision with hemostatic effect and create a potential barrier against bacterial infections.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        critical ill patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed consent signature&#xD;
&#xD;
          -  age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 90 years&#xD;
&#xD;
          -  Cianoacrilate allergy&#xD;
&#xD;
          -  Presence of bacteraemia&#xD;
&#xD;
          -  Informed consent refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elena Giovanna Bignami, MD</last_name>
    <phone>+39 0525033609</phone>
    <email>elenagiovanna.bignami@unipr.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria di Parma</name>
      <address>
        <city>Parma</city>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elena Giovanna Bignami, MD</last_name>
    </contact>
    <investigator>
      <last_name>Giada Maspero, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giuseppina Palumbo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Selene Ranocchia, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Andrea Rossi, Nurse</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nicolò Gallina, MD Student</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Parma</investigator_affiliation>
    <investigator_full_name>Elena Giovanna Bignami</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Port</keyword>
  <keyword>Glue</keyword>
  <keyword>CVC</keyword>
  <!-- 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/NCT03801811
org study id: 382/2018/DISP/AOUPR
nct id: NCT03801811
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The use of glue as a device in the implantation of central venous catheters has recently been
      introduced into European clinical practice, initially with the aim of blocking bleeding at
      the point of exit of the PICCs, but at the same time also to close the cutaneous incision
      practiced to create the PORT positioning pocket.

      It is possible that the surgical incision created for the insertion of the PORT may undergo
      complications such as: local bleeding, infections or wounds of the surgical wound.

      A solution to this problem could be the application of the cyanoacrylate dermal glue on the
      edges of the surgical wound, after intradermal suture. The glue would have the purpose of
      sealing the surgical wound so as to immediately seal the skin incision with hemostatic effect
      and create a potential barrier against infections.
Patient's informed consent signature for adhesion at the study will be initially requested.
      With their acceptance, parameters will be recorded anonymously in the Case Report Form,
      identified by a numeric code, until hospital discharge.

      The parameters analized will be related to:

        -  essential patient data (identification number, gender, age, height weight)

        -  basic diseases

        -  associated diseases and risk factors

        -  origin of the patient (department or home)

        -  reason for positioning

        -  hemorrhagic complications detected in the first 24 hours

        -  hemorrhagic complications detected in the first 7 days

        -  non-bleeding complications detected at 7 days (local and systemic infections, wound
           delescence)

      The data wil be transferred to an Excel worksheet, in order to conduct a descriptive analysis
      related to every variable
observational model: Cohort
time perspective: Prospective
measure: visible presence of blood around the emergency site
time frame: 24 hours
description: Evaluate the effectiveness of cyanoacrylate glue in reducing / eliminating bleeding local from the insertion site after PORT implantation (evaluated as visible presence of blood around the emergency site.
measure: Early infection of the emergency site;
time frame: 7 days
description: Rate of early infection of the emergency site; Early infection of the emergency site is assessed by observing skin changes as the presence of: pain, hot skin and reddened skin
measure: Deischence of the surgical wound
time frame: 15 days
description: Rate of dehiscence of the surgical wound. This will be assessed by looking for signs of bleeding, pain, fever and inflammation
measure: Systemic infection
time frame: 15 days
description: Rate of systemic infections will be evaluated by evaluating the presence of fever
intervention type: Procedure
intervention name: Study of the efficacy of using skin glue in the application of Port a cath
description: The use of glue as a device in the implantation of central venous catheters has recently been introduced into European clinical practice. It is possible that the surgical incision created for the insertion of the PORT may be subject to complications such as: local bleeding, which if not properly treated may last even a few days, infections or surgical wound outbreaks. This possibility of bleeding occurs more easily in patients suffering from coagulation problems or when appropriate preventive measures have not been taken at the time of implantation of the device. A solution to this problem could be the application of the cyanoacrylate dermal glue on the edges of the surgical wound, after intradermal suture. The glue would have the purpose of sealing the surgical wound so as to immediately seal the skin incision with hemostatic effect and create a potential barrier against bacterial infections.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Elena Giovanna Bignami, MD
phone: +39 0525033609
email: elenagiovanna.bignami@unipr.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Parma
investigator full name: Elena Giovanna Bignami
investigator title: Professor