<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/NCT03762200</url>
  </required_header>
  <id_info>
    <org_study_id>BIOS-2017-01</org_study_id>
    <nct_id>NCT03762200</nct_id>
  </id_info>
  <brief_title>SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects</brief_title>
  <official_title>A Prospective, Clinical Study Evaluating the Safety and Haemostatic Effectiveness of SURGICEL® Powder, in Mild or Moderate Parenchymal or Soft Tissue Bleeding During General, Gynaecological, Urological, and Cardiothoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ethicon, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ethicon, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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 is a prospective, single arm, multicentre, multispecialty, post market, clinical study&#xD;
      evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when&#xD;
      conventional methods of control are impractical or ineffective during surgery (open,&#xD;
      laparoscopic or thoracoscopic) in adult subjects (18 years or older).&#xD;
&#xD;
      After application of SURGICEL Powder, the Target Bleeding Site (TBS) will be assessed for&#xD;
      haemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to&#xD;
      initiation of closure.&#xD;
&#xD;
      All enrolled subjects will be followed post-operatively through discharge and again at 30&#xD;
      days and 6 months post-surgery via phone call or office visit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, prospective, single arm, multicentre, multispecialty, post-marketing&#xD;
      clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis in the control&#xD;
      of capillary, venous, and small arterial haemorrhage when ligation or other conventional&#xD;
      methods of control are impractical or ineffective during surgery (open, laparoscopic or&#xD;
      thoracoscopic) in adult subjects (18 years or older). Prospective subjects will be informed&#xD;
      about the nature of the research, given the informed consent form (ICF) to read, and, if&#xD;
      he/she understands the content, will be asked to provide consent by signing the ICF.&#xD;
&#xD;
      Screening and enrolment will continue until at least 100 evaluable subjects from&#xD;
      approximately eight (8) investigational sites, with an appropriate mild or moderate Target&#xD;
      Bleeding Site (TBS) are included into the study. The TBS will be the only region evaluated&#xD;
      for the primary endpoint and all secondary effectiveness endpoints.&#xD;
&#xD;
      All enrolled subjects will be followed post-operatively through discharge, and via phone call&#xD;
      or office visit at 30 days (+14 days) post-surgery. In addition, all enrolled subjects will&#xD;
      receive a 6-month (+/-30 days) follow-up phone call or office visit to assess the occurrence&#xD;
      of any serious adverse event (SAE) requiring surgical intervention and assessed as possibly&#xD;
      related or related to the study treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2018</start_date>
  <completion_date type="Actual">June 3, 2020</completion_date>
  <primary_completion_date type="Actual">December 2, 2019</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>Haemostatic Success at 5 Minutes</measure>
    <time_frame>From application of SURGICEL Powder to 5 minutes after application</time_frame>
    <description>Proportion of subjects achieving haemostatic success at 5 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Haemostatic Success at 3 Minutes</measure>
    <time_frame>From application of SURGICEL Powder to 3 minutes after application</time_frame>
    <description>Proportion of subjects achieving haemostatic success at 3 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Haemostatic Success at 10 Minutes</measure>
    <time_frame>From application of SURGICEL Powder to 10 minutes after application</time_frame>
    <description>Proportion of subjects achieving haemostatic success at 10 minutes following the application of SURGICEL Powder with no rebleeding that requires additional treatment at the TBS any time prior to initiation of final fascial closure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants Experiencing a Thromboembolic Event</measure>
    <time_frame>From application of SURGICEL Powder to 30 day follow-up visit</time_frame>
    <description>Number of participants experiencing a thromboembolic event that was assessed as having either an unlikely, possible, probable or causal relationship to the study treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Post-operative Re-bleeding</measure>
    <time_frame>From initiation of final fascial closure to the 30-day follow up visit</time_frame>
    <description>Number of participants of post-operative re-bleeding that was assessed as having either an unlikely, possible, probable or causal relationship to the TBS and requiring medical/surgical intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Experiencing a Serious Adverse Events Requiring Surgical Intervention and Related to SURGICEL Powder</measure>
    <time_frame>From time of SURGICEL Powder application to 6-month follow up visit</time_frame>
    <description>Number of participants experiencing a serious adverse event requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Hemorrhage</condition>
  <arm_group>
    <arm_group_label>SURGICEL Powder - Single arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Single arm clinical trial where all qualified subjects will be treated SURGICEL Powder</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SURGICEL Powder</intervention_name>
    <description>SURGICEL Powder is a topical absorbable hemostatic treatment made of oxidized regenerated cellulose (ORC) - plant material</description>
    <arm_group_label>SURGICEL Powder - Single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Pre-operative:&#xD;
&#xD;
          1. Adult subjects ≥ 18 years requiring elective/non-emergent open or laparoscopic&#xD;
             general, gynaecological, cardiothoracic, or urological surgical procedures;&#xD;
&#xD;
          2. Subject or authorised representative has signed the approved Informed Consent;&#xD;
&#xD;
          3. Subject(s) whose International Normalised Ratio is &lt;1.5 within 24 hours of surgery.&#xD;
&#xD;
             Intra-operative:&#xD;
&#xD;
          4. Presence of an appropriate TBS identified intra-operatively by the surgeon;&#xD;
&#xD;
          5. Subject(s) undergoing cardiothoracic surgery with anticoagulation must have&#xD;
             anticoagulation reversed prior to TBS identification and treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pre-operative:&#xD;
&#xD;
          1. Female subjects who are pregnant or nursing;&#xD;
&#xD;
          2. Subject on anticoagulation medication (with exception of aspirin) prior to surgery.&#xD;
             Washout periods for respective medications must be observed.&#xD;
&#xD;
             If information is not readily available within the Instructions for Use (IFU), a&#xD;
             conservative approach should be taken and intravenous heparin stopped 12 hours prior&#xD;
             to surgery and 2 days prior for oral medication;&#xD;
&#xD;
          3. Subject on antiplatelet/P2Y12 inhibitors medication prior to surgery. Platelet&#xD;
             recovery times for respective medication must be observed. If information is not&#xD;
             readily available within the IFU, a conservative approach should be taken and&#xD;
             medication stopped 5 days prior to surgery.&#xD;
&#xD;
          4. Subject is currently participating or plans to participate in any other&#xD;
             investigational device or drug without prior approval from the Sponsor;&#xD;
&#xD;
          5. Subjects who are known, current alcohol and/or drug abusers;&#xD;
&#xD;
          6. Subjects with any pre-operative findings identified by the surgeon that may preclude&#xD;
             conduct of the study procedure.&#xD;
&#xD;
             Intra-operative:&#xD;
&#xD;
          7. Subjects with any intra-operative findings identified by the surgeon that may preclude&#xD;
             the use of study product;&#xD;
&#xD;
          8. Subject with TBS in an actively infected field [Class III Contaminated or Class IV&#xD;
             Dirty or Infected (see Appendix 2 in in Section 15.2)];&#xD;
&#xD;
          9. TBS is on arteries or veins where application of SURGICEL Powder would present a risk&#xD;
             of introducing the study product into an open blood vessel;&#xD;
&#xD;
         10. Major arterial or venous bleeding or major defects in arteries and veins;&#xD;
&#xD;
         11. TBS where silver nitrate or any other escharotic chemicals have been applied;&#xD;
&#xD;
         12. TBS is in, around, or in proximity to foramina in bone, or areas of bony confine, the&#xD;
             spinal cord, or optic nerve and chiasm;&#xD;
&#xD;
         13. TBS in urological procedures where plugging (blocking) of the urethra, ureter or a&#xD;
             catheter is possible by the study product.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ziekenhuis Oost Limburg</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NHS Lothian (Western General Hospital)</name>
      <address>
        <city>Edinburgh</city>
        <state>Lothian</state>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cambridge University Hospitals NHS Trust (Addenbrooke's Hospital)</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0QQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Golden Jubilee National Hospital</name>
      <address>
        <city>Clydebank</city>
        <zip>G81 4DY, GB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds Teaching Hospitals NHS Trust (St James's University Hospital)</name>
      <address>
        <city>Leeds</city>
        <zip>LS9 7TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newcastle upon Tyne NHS Foundation Trust (Freeman Hospital)</name>
      <address>
        <city>Newcastle upon Tyne</city>
        <zip>NE7 7DN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 3, 2018</study_first_posted>
  <results_first_submitted>December 1, 2020</results_first_submitted>
  <results_first_submitted_qc>December 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 22, 2020</results_first_posted>
  <last_update_submitted>July 23, 2021</last_update_submitted>
  <last_update_submitted_qc>July 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>bleeding</keyword>
  <keyword>broad area oozing bleeding</keyword>
  <keyword>hemostat</keyword>
  <keyword>topical hemostatic agents</keyword>
  <keyword>adjunctive hemostats</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 16, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03762200/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 4, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/00/NCT03762200/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were screened up to 21 days prior to surgery and attended a baseline visit within 24 hours of surgery. Both visits took place at a clinic within the hospital where surgery also took place. Subjects were followed until hospital discharge and requested to attend a visit at 30 (+14) days post surgery and at 6 months (+/- 30 days) either at the hospital or via telephone.</recruitment_details>
      <pre_assignment_details>Subjects required to meet pre-defined inclusion/exclusion criteria prior to receiving study product. Subjects required to have an appropriate mild or moderate target bleeding site (TBS) identified intra-operatively. Subjects excluded if the TBS was where silver nitrate or any other escharotic chemicals were applied, was in, around, or in proximity to foramina in bone, areas of bony confine or where plugging of the urethra, ureter or a catheter was possible by study product.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SURGICEL Powder</title>
          <description>Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="103"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>SURGICEL Powder</title>
          <description>Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="103"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <title>Age at Consent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64.0" lower_limit="33.0" upper_limit="88.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Race : White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Race : Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Race : Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Haemostatic Success at 5 Minutes</title>
        <description>Proportion of subjects achieving haemostatic success at 5 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure</description>
        <time_frame>From application of SURGICEL Powder to 5 minutes after application</time_frame>
        <population>Intent to Treat (All subjects for whom TBS was identified)</population>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Haemostatic Success at 5 Minutes</title>
          <description>Proportion of subjects achieving haemostatic success at 5 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure</description>
          <population>Intent to Treat (All subjects for whom TBS was identified)</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Confidence Interval</non_inferiority_desc>
            <param_type>percentage of sucesses</param_type>
            <param_value>87.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>79.4</ci_lower_limit>
            <ci_upper_limit>93.1</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Haemostatic Success at 3 Minutes</title>
        <description>Proportion of subjects achieving haemostatic success at 3 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure</description>
        <time_frame>From application of SURGICEL Powder to 3 minutes after application</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Haemostatic Success at 3 Minutes</title>
          <description>Proportion of subjects achieving haemostatic success at 3 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Confidence Interval</non_inferiority_desc>
            <param_type>Percentage of Successes</param_type>
            <param_value>77.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>68.4</ci_lower_limit>
            <ci_upper_limit>85.3</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Haemostatic Success at 10 Minutes</title>
        <description>Proportion of subjects achieving haemostatic success at 10 minutes following the application of SURGICEL Powder with no rebleeding that requires additional treatment at the TBS any time prior to initiation of final fascial closure</description>
        <time_frame>From application of SURGICEL Powder to 10 minutes after application</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Haemostatic Success at 10 Minutes</title>
          <description>Proportion of subjects achieving haemostatic success at 10 minutes following the application of SURGICEL Powder with no rebleeding that requires additional treatment at the TBS any time prior to initiation of final fascial closure</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <non_inferiority_desc>Confidence Interval</non_inferiority_desc>
            <param_type>Percentage of Successes</param_type>
            <param_value>92.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>85.3</ci_lower_limit>
            <ci_upper_limit>96.6</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Experiencing a Thromboembolic Event</title>
        <description>Number of participants experiencing a thromboembolic event that was assessed as having either an unlikely, possible, probable or causal relationship to the study treatment</description>
        <time_frame>From application of SURGICEL Powder to 30 day follow-up visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing a Thromboembolic Event</title>
          <description>Number of participants experiencing a thromboembolic event that was assessed as having either an unlikely, possible, probable or causal relationship to the study treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Post-operative Re-bleeding</title>
        <description>Number of participants of post-operative re-bleeding that was assessed as having either an unlikely, possible, probable or causal relationship to the TBS and requiring medical/surgical intervention</description>
        <time_frame>From initiation of final fascial closure to the 30-day follow up visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Post-operative Re-bleeding</title>
          <description>Number of participants of post-operative re-bleeding that was assessed as having either an unlikely, possible, probable or causal relationship to the TBS and requiring medical/surgical intervention</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Experiencing a Serious Adverse Events Requiring Surgical Intervention and Related to SURGICEL Powder</title>
        <description>Number of participants experiencing a serious adverse event requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment</description>
        <time_frame>From time of SURGICEL Powder application to 6-month follow up visit</time_frame>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing a Serious Adverse Events Requiring Surgical Intervention and Related to SURGICEL Powder</title>
          <description>Number of participants experiencing a serious adverse event requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="103"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from time product applied to TBS and up to 30 (+14) day follow-up visit. From initiation of final fascial closure to 6-month follow-up visit, SAEs requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment were recorded.</time_frame>
      <desc>For this study, an AE is an untoward medical occurrence (sign, symptom or disease) in a subject and which does not necessarily have a causal relationship with the study medical device. An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition.</desc>
      <group_list>
        <group group_id="E1">
          <title>SURGICEL Powder</title>
          <description>Absorbable Haemostatic Powder (Oxidized Regenerated Cellulose)</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Gastroduodenal haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pancreatic fistula</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Device related sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Urosepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural bile leak</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Heart rate irregular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Metastases to lung</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pancreatic carcinoma metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pleuritic pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Haemodynamic instability</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Iron Deficiency anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Thromobocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal distension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Impaired gastric emptying</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Intra-abdominal fluid collection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Intra-abdominal haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="23" subjects_affected="22" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Obstruction gastric</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Steatorrhoea</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hypothermia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Ischaemic hepatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Abdominal infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Bacterial infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Biliary tract infection bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Escherichia infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Febrile infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Lower respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Oral candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Postoperative wound infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Gastroparesis postoperative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Wound secretion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Bile culture positive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Blood lactic acid increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Blood magnesium decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Blood potassium decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Body temperature increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Haematocrit decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Haemoglobin decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Liver function test abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Prothrombin time prolonged</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Red blood cell count decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Urine output decreased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Electrolyte imbalance</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Metabolic acidosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia nervosa</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Delirium</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hallucination</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Oliguria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Urinary retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Testicular pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Vaginal haemorrhage</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Lung consolidation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Wheezing</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pityriasis rubra pilaris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Rash pruritic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="103"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="103"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Publication based on results shall not be made before the first multi-centre publication.&#xD;
Trust and/or Investigator may prepare data derived from the Clinical Investigation for publication. Sponsor to be given at least 60 days for review. During review period, Sponsor is entitled to request publication be delayed for up to 6 months from date of first submission to Sponsor to enable Sponsor to take steps to protect its proprietary information and/or Intellectual Property Rights and Know How.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Patricia Schleckser</name_or_title>
      <organization>ETHICON, Inc</organization>
      <phone>01 908 218 2244</phone>
      <email>PSchleck@its.jnj.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03762200
org study id: BIOS-2017-01
nct id: NCT03762200
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This is a prospective, single arm, multicentre, multispecialty, post market, clinical study
      evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when
      conventional methods of control are impractical or ineffective during surgery (open,
      laparoscopic or thoracoscopic) in adult subjects (18 years or older).

      After application of SURGICEL Powder, the Target Bleeding Site (TBS) will be assessed for
      haemostasis (no detectable bleeding) at 3, 5, and 10 minutes from application and prior to
      initiation of closure.

      All enrolled subjects will be followed post-operatively through discharge and again at 30
      days and 6 months post-surgery via phone call or office visit.
This is an open label, prospective, single arm, multicentre, multispecialty, post-marketing
      clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis in the control
      of capillary, venous, and small arterial haemorrhage when ligation or other conventional
      methods of control are impractical or ineffective during surgery (open, laparoscopic or
      thoracoscopic) in adult subjects (18 years or older). Prospective subjects will be informed
      about the nature of the research, given the informed consent form (ICF) to read, and, if
      he/she understands the content, will be asked to provide consent by signing the ICF.

      Screening and enrolment will continue until at least 100 evaluable subjects from
      approximately eight (8) investigational sites, with an appropriate mild or moderate Target
      Bleeding Site (TBS) are included into the study. The TBS will be the only region evaluated
      for the primary endpoint and all secondary effectiveness endpoints.

      All enrolled subjects will be followed post-operatively through discharge, and via phone call
      or office visit at 30 days (+14 days) post-surgery. In addition, all enrolled subjects will
      receive a 6-month (+/-30 days) follow-up phone call or office visit to assess the occurrence
      of any serious adverse event (SAE) requiring surgical intervention and assessed as possibly
      related or related to the study treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Haemostatic Success at 5 Minutes
time frame: From application of SURGICEL Powder to 5 minutes after application
description: Proportion of subjects achieving haemostatic success at 5 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure
measure: Haemostatic Success at 3 Minutes
time frame: From application of SURGICEL Powder to 3 minutes after application
description: Proportion of subjects achieving haemostatic success at 3 minutes following application of SURGICEL Powder with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure
measure: Haemostatic Success at 10 Minutes
time frame: From application of SURGICEL Powder to 10 minutes after application
description: Proportion of subjects achieving haemostatic success at 10 minutes following the application of SURGICEL Powder with no rebleeding that requires additional treatment at the TBS any time prior to initiation of final fascial closure
measure: Number of Participants Experiencing a Thromboembolic Event
time frame: From application of SURGICEL Powder to 30 day follow-up visit
description: Number of participants experiencing a thromboembolic event that was assessed as having either an unlikely, possible, probable or causal relationship to the study treatment
measure: Number of Participants With Post-operative Re-bleeding
time frame: From initiation of final fascial closure to the 30-day follow up visit
description: Number of participants of post-operative re-bleeding that was assessed as having either an unlikely, possible, probable or causal relationship to the TBS and requiring medical/surgical intervention
measure: Number of Participants Experiencing a Serious Adverse Events Requiring Surgical Intervention and Related to SURGICEL Powder
time frame: From time of SURGICEL Powder application to 6-month follow up visit
description: Number of participants experiencing a serious adverse event requiring surgical intervention and assessed as having either an unlikely, possible, probable or causal relationship to the study treatment
arm group label: SURGICEL Powder - Single arm
arm group type: Other
description: Single arm clinical trial where all qualified subjects will be treated SURGICEL Powder
intervention type: Device
intervention name: SURGICEL Powder
description: SURGICEL Powder is a topical absorbable hemostatic treatment made of oxidized regenerated cellulose (ORC) - plant material
arm group label: SURGICEL Powder - Single arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: United Kingdom
responsible party type: Sponsor
mesh term: Hemorrhage
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 