<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/NCT03783039</url>
  </required_header>
  <id_info>
    <org_study_id>BIOS_2017_02</org_study_id>
    <nct_id>NCT03783039</nct_id>
  </id_info>
  <brief_title>The SURGICEL® Powder Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding (China Study)</brief_title>
  <official_title>A Prospective, RCT Evaluating the Safety and Hemostatic Effectiveness of SURGICEL Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding During Surgery in Chinese Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ethicon, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ethicon, LLC</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 is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL&#xD;
      Original (control arm) as an adjunct to achieve hemostasis in the control of capillary,&#xD;
      venous, and small arterial hemorrhage when ligation or other conventional methods of control&#xD;
      are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in&#xD;
      Chinese adult subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL&#xD;
      Original (control arm) as an adjunct to achieve hemostasis in the control of capillary,&#xD;
      venous, and small arterial hemorrhage when ligation or other conventional methods of control&#xD;
      are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in&#xD;
      Chinese adult subjects.&#xD;
&#xD;
      After application of either SURGICEL Powder or SURGICEL Original, the target bleeding site&#xD;
      (TBS) will be assessed for hemostasis (no detectable bleeding) at 3, 5, and 10 minutes from&#xD;
      application and prior to initiation of final fascial closure on open surgery or port site&#xD;
      closure in laparoscopic or thoracoscopic procedures.&#xD;
&#xD;
      All enrolled subjects will be observed post-operatively through discharge and followed up at&#xD;
      30 days (+14 days) and at 6 months (+/-30 days) post-surgery via phone call or office visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Actual">May 6, 2020</completion_date>
  <primary_completion_date type="Actual">December 3, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemostatic Success at 5 Minutes</measure>
    <time_frame>From product application to 5 minutes following product application</time_frame>
    <description>Percentage of subjects achieving hemostatic success at 5 minutes following study product application 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>Hemostatic Success at 3 Minutes</measure>
    <time_frame>From product application to 3 minutes following product application</time_frame>
    <description>Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemostatic Success at 10 Minutes</measure>
    <time_frame>From product application to 10 minutes following product application</time_frame>
    <description>Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Participants With Thromboembolic Events</measure>
    <time_frame>From enrollment to 30-day follow-up visit</time_frame>
    <description>Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Post-operative Re-bleeding Events</measure>
    <time_frame>From initiation of final fascial closure to 30-day follow-up visit</time_frame>
    <description>Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants With Serious Adverse Events Requiring Surgical Intervention</measure>
    <time_frame>From enrollment to 6 month follow up visit</time_frame>
    <description>Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">234</enrollment>
  <condition>Hemorrhage</condition>
  <arm_group>
    <arm_group_label>SURGICEL Powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SURGICEL Original</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>SURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SURGICEL Powder</intervention_name>
    <description>Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Powder, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.</description>
    <arm_group_label>SURGICEL Powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SURGICEL Original</intervention_name>
    <description>Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Original, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.</description>
    <arm_group_label>SURGICEL Original</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult subjects aged ≥18 years requiring elective/non-emergent open or laparoscopic&#xD;
             general, gynecological, or cardiothoracic surgical procedures.&#xD;
&#xD;
          2. Subject or authorized representative has signed the approved Informed Consent.&#xD;
&#xD;
          3. Subject(s) whose platelet count is ≥100,000 per microliter and International&#xD;
             Normalized Ratio (INR) is &lt;1.5 prior to 24 hours of surgery.&#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;
          1. Female subjects who are pregnant or nursing.&#xD;
&#xD;
          2. Subject on heparin within 12 hours prior to surgery, or oral Coumadin (warfarin)&#xD;
             and/or Factor Xa inhibitors within 3 days prior to surgery.&#xD;
&#xD;
          3. Subject on antiplatelet/P2Y12 inhibitors medication 5 days prior to surgery;&#xD;
&#xD;
          4. Subject is currently participating or plans to participate in any other&#xD;
             investigational product or drug trial 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;
          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 1).&#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&#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>Zhejiang Provincial People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital - Nanjing University Medical School</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital - Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Xinhua Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Xuzhou Medical University</name>
      <address>
        <city>Xuzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 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>June 17, 2021</last_update_submitted>
  <last_update_submitted_qc>June 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 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>
    <mesh_term>Blood Loss, Surgical</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cellulose, Oxidized</mesh_term>
  </intervention_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>September 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03783039/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>July 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03783039/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.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>SURGICEL Powder</title>
          <description>SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
        </group>
        <group group_id="P2">
          <title>SURGICEL Original</title>
          <description>Absorbable Hemostat (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="119"/>
                <participants group_id="P2" count="115"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="117"/>
                <participants group_id="P2" count="114"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </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>SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
        </group>
        <group group_id="B2">
          <title>SURGICEL Original</title>
          <description>Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="119"/>
            <count group_id="B2" value="115"/>
            <count group_id="B3" value="234"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.0" lower_limit="20" upper_limit="96"/>
                    <measurement group_id="B2" value="52.0" lower_limit="23" upper_limit="89"/>
                    <measurement group_id="B3" value="53.0" lower_limit="20" upper_limit="96"/>
                  </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="77"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="150"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="84"/>
                  </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>Han</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="116"/>
                    <measurement group_id="B2" value="114"/>
                    <measurement group_id="B3" value="230"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hemostatic Success at 5 Minutes</title>
        <description>Percentage of subjects achieving hemostatic success at 5 minutes following study product application 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 product application to 5 minutes following product application</time_frame>
        <population>Per Protocol Analysis (All intent to treat subjects who have no major protocol deviations and have data available for primary effectiveness endpoint)</population>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Original</title>
            <description>Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Hemostatic Success at 5 Minutes</title>
          <description>Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure</description>
          <population>Per Protocol Analysis (All intent to treat subjects who have no major protocol deviations and have data available for primary effectiveness endpoint)</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="114"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>10% margin</non_inferiority_desc>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Testing whether the group difference in proportion of successes is &gt;-0.1 (Test Group - Control Group)</p_value_desc>
            <method>Farrington-Manning method</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>0.0605</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>1-Sided</ci_n_sides>
            <ci_lower_limit>-0.0189</ci_lower_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemostatic Success at 3 Minutes</title>
        <description>Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure</description>
        <time_frame>From product application to 3 minutes following product application</time_frame>
        <population>Intent to Treat Analysis (All randomized and enrolled subjects for whom TBS was identified. Subjects who did not complete the procedure after TBS identification were included in the ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Original</title>
            <description>Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Hemostatic Success at 3 Minutes</title>
          <description>Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure</description>
          <population>Intent to Treat Analysis (All randomized and enrolled subjects for whom TBS was identified. Subjects who did not complete the procedure after TBS identification were included in the ITT)</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="119"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="107"/>
                    <measurement group_id="O2" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in proportion of successes</param_type>
            <param_value>0.0992</param_value>
            <ci_percent>95.0</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.0078</ci_lower_limit>
            <ci_upper_limit>0.1906</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hemostatic Success at 10 Minutes</title>
        <description>Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure</description>
        <time_frame>From product application to 10 minutes following product application</time_frame>
        <population>Intent to Treat Analysis (All randomized and enrolled subjects for whom TBS was identified. Subjects who did not complete the procedure after TBS identification were included in the ITT)</population>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Original</title>
            <description>Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Hemostatic Success at 10 Minutes</title>
          <description>Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure</description>
          <population>Intent to Treat Analysis (All randomized and enrolled subjects for whom TBS was identified. Subjects who did not complete the procedure after TBS identification were included in the ITT)</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="119"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="114"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <param_type>Difference in proportion of successes</param_type>
            <param_value>0.0275</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.0312</ci_lower_limit>
            <ci_upper_limit>0.0863</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Thromboembolic Events</title>
        <description>Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment</description>
        <time_frame>From enrollment to 30-day follow-up visit</time_frame>
        <population>Safety Analysis Set (All enrolled subjects who underwent study procedure and received study product, and had post-baseline data. Enrollment defined as subjects with completed informed consent and meets all inclusion criteria and does not meet any exclusion criteria)</population>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Original</title>
            <description>Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Thromboembolic Events</title>
          <description>Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment</description>
          <population>Safety Analysis Set (All enrolled subjects who underwent study procedure and received study product, and had post-baseline data. Enrollment defined as subjects with completed informed consent and meets all inclusion criteria and does not meet any exclusion criteria)</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="119"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Investigator Assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sponsor Assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" 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 Events</title>
        <description>Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention</description>
        <time_frame>From initiation of final fascial closure to 30-day follow-up visit</time_frame>
        <population>Safety Analysis Set (All enrolled subjects who underwent study procedure and received study product, and had post-baseline data. Enrollment defined as subjects with completed informed consent and meets all inclusion criteria and does not meet any exclusion criteria)</population>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Original</title>
            <description>Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Post-operative Re-bleeding Events</title>
          <description>Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention</description>
          <population>Safety Analysis Set (All enrolled subjects who underwent study procedure and received study product, and had post-baseline data. Enrollment defined as subjects with completed informed consent and meets all inclusion criteria and does not meet any exclusion criteria)</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="119"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Investigator Assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sponsor Assessment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants With Serious Adverse Events Requiring Surgical Intervention</title>
        <description>Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment</description>
        <time_frame>From enrollment to 6 month follow up visit</time_frame>
        <population>Safety Analysis Set (All enrolled subjects who underwent study procedure and received study product, and had post-baseline data. Enrollment defined as subjects with completed informed consent and meets all inclusion criteria and does not meet any exclusion criteria)</population>
        <group_list>
          <group group_id="O1">
            <title>SURGICEL Powder</title>
            <description>SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
          <group group_id="O2">
            <title>SURGICEL Original</title>
            <description>Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Serious Adverse Events Requiring Surgical Intervention</title>
          <description>Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment</description>
          <population>Safety Analysis Set (All enrolled subjects who underwent study procedure and received study product, and had post-baseline data. Enrollment defined as subjects with completed informed consent and meets all inclusion criteria and does not meet any exclusion criteria)</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="119"/>
                <count group_id="O2" value="115"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All adverse events (serious and non-serious), whether attributable to device/procedure or not, were recorded from enrollment (informed consent and subject met all incl/excl criteria), during surgical procedure, and until completion of 30-day follow-up visit. Between 30 day and 6 month visit, all SAEs requiring surgical intervention and assessed as possibly/related to study treatment were recorded. All deaths were recorded regardless of relationship to product or procedure.</time_frame>
      <desc>For this study, an adverse event was any 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>SURGICEL Powder Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
        </group>
        <group group_id="E2">
          <title>SURGICEL Original</title>
          <description>Absorbable Hemostat (Oxidized Regenerated Cellulose)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 21.1</default_vocab>
        <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="119"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="119"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Hemophilia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hemorrhagic Ascites</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Intra-abdominal Hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Peritoneal Hemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Liver Abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Post Procedural Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anastomotic Fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Post Procedural Bile Leak</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Post Procedural Hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral Infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hemorrhage Intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary Air Leakage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Respiratory Distress</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Shock Hemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Venous Thrombosis Limb</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 21.1</default_vocab>
        <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="83" subjects_at_risk="119"/>
                <counts group_id="E2" subjects_affected="80" subjects_at_risk="115"/>
              </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="3" subjects_affected="3" subjects_at_risk="119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Leukocytosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Lymphocytopenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Bone Marrow Failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hemorrhagic Anaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Myocardial Reperfusion Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Ventricular Extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="119"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="119"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="119"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="119"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Dyschezia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Abdominal Discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Flatulence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Abdominal Tenderness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Anal Hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Appendicitis Noninfective</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Chronic Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Dysbacteriosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Gastroesophageal Reflux Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Impaired Gastric Emptying</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Mouth Hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pancreatic Fistula</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Phase Reaction</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="119"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="119"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hepatic Steatosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hepatic Function Abnormal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Abdominal Infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Postoperative Wound Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Fallopian Tube Abscess</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Lower Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Candidiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incision Site Pain</sub_title>
                <counts group_id="E1" events="34" subjects_affected="33" subjects_at_risk="119"/>
                <counts group_id="E2" events="28" subjects_affected="26" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Incision Site Complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Procedural Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Anaemia postoperative</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Incision Site Hemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pancreatic Leak</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Post Procedural Discharge</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Post Procedural Fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Wound Complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>White Blood Cell Count Increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="119"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Inflammatory Marker Increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="119"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Blood Pressure Increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="119"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Blood Potassium Decreased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Blood Pressure Decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>C-reactive Protein Increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Coagulation Test Abnormal</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Protein Total Decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Urine Output Decreased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="119"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hypoproteinaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="119"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Metabolic Acidosis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Acidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hypochloraemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung Adenocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </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="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Poor Quality Sleep</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Initial Insomnia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Dysuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Renal Cyst</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Vaginal Hemorrhage</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Vulvovaginal Pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </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="5" subjects_affected="5" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Oropharyngeal Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Productive Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis Allergic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Eczema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Papule</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Subcutaneous Emphysema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="115"/>
              </event>
              <event>
                <sub_title>Ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="119"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="115"/>
              </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>Principal investigator and institution will not be able to publish single-center study data until combined results of the multicenter study are published. If multicenter publication is not performed within 12 months after the end or if sponsor notifies principal investigator and institution in writing that the multicenter study results will not be published, the principal investigator and institution may publish the results of their studies separately in accordance with contract.</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/NCT03783039
org study id: BIOS_2017_02
nct id: NCT03783039
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL
      Original (control arm) as an adjunct to achieve hemostasis in the control of capillary,
      venous, and small arterial hemorrhage when ligation or other conventional methods of control
      are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in
      Chinese adult subjects.
This is a single blind, randomized, prospective study comparing SURGICEL Powder with SURGICEL
      Original (control arm) as an adjunct to achieve hemostasis in the control of capillary,
      venous, and small arterial hemorrhage when ligation or other conventional methods of control
      are impractical or ineffective during surgery (open, laparoscopic, or thoracoscopic) in
      Chinese adult subjects.

      After application of either SURGICEL Powder or SURGICEL Original, the target bleeding site
      (TBS) will be assessed for hemostasis (no detectable bleeding) at 3, 5, and 10 minutes from
      application and prior to initiation of final fascial closure on open surgery or port site
      closure in laparoscopic or thoracoscopic procedures.

      All enrolled subjects will be observed post-operatively through discharge and followed up at
      30 days (+14 days) and at 6 months (+/-30 days) post-surgery via phone call or office visit.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Hemostatic Success at 5 Minutes
time frame: From product application to 5 minutes following product application
description: Percentage of subjects achieving hemostatic success at 5 minutes following study product application with no rebleeding requiring additional treatment at the Target Bleeding Site (TBS) any time prior to initiation of final fascial closure
measure: Hemostatic Success at 3 Minutes
time frame: From product application to 3 minutes following product application
description: Percentage of subjects achieving hemostatic success at 3 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure
measure: Hemostatic Success at 10 Minutes
time frame: From product application to 10 minutes following product application
description: Percentage of subjects achieving hemostatic success at 10 minutes following study product application with no rebleeding requiring additional treatment at the TBS any time prior to initiation of final fascial closure
measure: Number of Participants With Thromboembolic Events
time frame: From enrollment to 30-day follow-up visit
description: Number of participants with thrombotic events assessed as unlikely, possibly, probably or related to the study treatment
measure: Number of Participants With Post-operative Re-bleeding Events
time frame: From initiation of final fascial closure to 30-day follow-up visit
description: Number of participants with post-operative re-bleeding events assessed as unlikely, possibly, probably or related to study treatment and requiring medical/surgical intervention
measure: Number of Participants With Serious Adverse Events Requiring Surgical Intervention
time frame: From enrollment to 6 month follow up visit
description: Number of Participants with Serious Adverse Events requiring surgical intervention and assessed as being unlikely, possibly, probably or related to study treatment
arm group label: SURGICEL Powder
arm group type: Experimental
description: SURGICEL Powder is an absorbable hemostat that is oxidized regenerated cellulose in a powder form
arm group label: SURGICEL Original
arm group type: Active Comparator
description: SURGICEL Original is an bsorbable hemostat that is oxidized regenerated cellulose in a fabric form
intervention type: Device
intervention name: SURGICEL Powder
description: Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Powder, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.
arm group label: SURGICEL Powder
intervention type: Device
intervention name: SURGICEL Original
description: Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Original, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.
arm group label: SURGICEL Original
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
mesh term: Cellulose, Oxidized
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 