xml: <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/NCT05986201</url>
    </required_header>
    <id_info>
      <org_study_id>IDC-003</org_study_id>
      <nct_id>NCT05986201</nct_id>
    </id_info>
    <brief_title>Assessment of Long-term Effects of Tachosil</brief_title>
    <official_title>Assessment of Long-term Effects of Intraoperative Use of a Carrier-bound Fibrin Sealant (TachoSil®). We Had to Continue to Use it?</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Catania</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Catania</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study aimed to analyse the long-term effects of a carrier-bound fibrin sealant (CBFS)&#xD;
        after abdominal surgery by following up patients years after application.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2016</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">May 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>fibrotic reaction</measure>
      <time_frame>10 years</time_frame>
      <description>The evaluation focused on individuation of the area treated with CBFS, comprehensive analysis of the dimensions of the area treated if visible, and evolution, focusing on the presence of fibrosis, sclerosis, collections, cysts, or pseudocysts. The formation of a fibrotic reaction was related to the presence of residual tissue on CT during follow-up.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Actual">40</enrollment>
    <condition>Fibrin Sealant</condition>
    <condition>Haemostasis</condition>
    <arm_group>
      <arm_group_label>40 patients</arm_group_label>
      <description>There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>TachoSil®</intervention_name>
      <description>TachoSil®, a carrier-bound fibrin sealant (CBFS), is a haemostatic tissue sealant composed of a collagen sponge, made from horse tendons, coated on one side with dried human fibrinogen and human thrombin.</description>
      <arm_group_label>40 patients</arm_group_label>
      <other_name>haemostatic tissue sealant</other_name>
      <other_name>carrier-bound fibrin sealant</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8&#xD;
          years.&#xD;
  &#xD;
          The indications for surgery were hepatocellular carcinoma 23 (57.5%), hydatid cyst 3&#xD;
          (7.5%), hepatic adenoma 1 (2.5%), hepatic trauma 2 (5.0%), cholecystitis 2 (5.0%), 3&#xD;
          (7.5%), splenic rupture or bleeding for trauma 1 (2.5%), neuroendocrine tumour and trauma&#xD;
          of the pancreas 1 (2.5%), peptic gastric ulcer 3 (7.5%), and colon cancer 1 (2.5%).&#xD;
  &#xD;
          There were 29 hepatic surgical procedures: 4 left lobectomies, 2 right hepatectomies, 9&#xD;
          segmentectomies, 2 bi-segmentectomies, 8 limited resections, and 1 enucleation following&#xD;
          the Couinaud classification (23); 2 partial cystopericistectomies, 1 simple suture of the&#xD;
          traumatic lobe of the liver after biliary check; 2 cholecystectomies, 3 total&#xD;
          splenectomies, 1 enucleation of tumour of the tail of the pancreas, 1 haemostasis of the&#xD;
          traumatic tail of the pancreas, 3 sutures of ulcer of the stomach, and 1 colon cancer&#xD;
          resection.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  type of surgery, indication for surgery, type of disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  dead patients, not available on call.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>32 Years</minimum_age>
      <maximum_age>87 Years</maximum_age>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Catania</investigator_affiliation>
      <investigator_full_name>Isidoro Di Carlo, MD, PhD, FACS</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Fibrin Tissue Adhesive</mesh_term>
      <mesh_term>Hemostatics</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05986201
  org study id: IDC-003
  nct id: NCT05986201
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  This study aimed to analyse the long-term effects of a carrier-bound fibrin sealant (CBFS)
        after abdominal surgery by following up patients years after application.
  observational model: Case-Control
  time perspective: Retrospective
  measure: fibrotic reaction
  time frame: 10 years
  description: The evaluation focused on individuation of the area treated with CBFS, comprehensive analysis of the dimensions of the area treated if visible, and evolution, focusing on the presence of fibrosis, sclerosis, collections, cysts, or pseudocysts. The formation of a fibrotic reaction was related to the presence of residual tissue on CT during follow-up.
  arm group label: 40 patients
  description: There were 33 (82.5%) males and 7 (17.5%) females aged 32-87 years, with a mean age of 67.8 years.
  intervention type: Device
  intervention name: TachoSil®
  description: TachoSil®, a carrier-bound fibrin sealant (CBFS), is a haemostatic tissue sealant composed of a collagen sponge, made from horse tendons, coated on one side with dried human fibrinogen and human thrombin.
  arm group label: 40 patients
  other name: haemostatic tissue sealant
  other name: carrier-bound fibrin sealant
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 32 Years
  maximum age: 87 Years
  responsible party type: Principal Investigator
  investigator affiliation: University of Catania
  investigator full name: Isidoro Di Carlo, MD, PhD, FACS
  investigator title: Professor
  mesh term: Fibrin Tissue Adhesive
  mesh term: Hemostatics