<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/NCT01684020</url>
  </required_header>
  <id_info>
    <org_study_id>ART-RHI-12</org_study_id>
    <nct_id>NCT01684020</nct_id>
  </id_info>
  <brief_title>A Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty</brief_title>
  <official_title>A Prospective, Double-Blinded, Randomized Study Evaluating the Efficacy and Safety of ARTISS Human Fibrin Sealant as Used in External Rhinoplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>DeNova Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Baxter Healthcare Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>DeNova Research</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rhinoplasty (nasal reconstruction i.e. &quot;a nose job&quot;) is a surgical procedure performed on the&#xD;
      nose to correct a medical problem or change the appearance of the nose. During the healing&#xD;
      process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin Sealant may&#xD;
      or may not lessen these effects. This study is looking to see the effects of ARTISS on&#xD;
      adhering tissue and improving wound healing in an external rhinoplasty. The purpose of this&#xD;
      study is to evaluate the safety and effectiveness of rhinoplasty using ARTISS compared to&#xD;
      rhinoplasty without using ARTISS in patients undergoing rhinoplasty performed through an&#xD;
      external approach.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2012</start_date>
  <completion_date type="Actual">April 26, 2016</completion_date>
  <primary_completion_date type="Actual">April 26, 2016</primary_completion_date>
  <phase>Phase 2</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Edema Severity</measure>
    <time_frame>Measured at Day 1, 7, 30, 180</time_frame>
    <description>Measured at Day 1, 7, 30, 180&#xD;
0 None- No apparent edema&#xD;
Mild- Minimal tissue swelling&#xD;
Moderate- Moderate edema, nasal features still discernible&#xD;
Severe- Marked swelling, difficulty distinguishing nasal features&#xD;
Scores closer to 0 indicate more favorable results</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Median Number of Adverse Events</measure>
    <time_frame>1 day, 1 week, 4 weeks and 6 months following surgery</time_frame>
    <description>Safety will be assessed by the incidence of AEs throughout the study period as documented by clinician observations at study visits and in a 30-day subject diary.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blinded-assessment of Satisfaction</measure>
    <time_frame>Measured at Baseline, 1 month, 3 months, 6 months, 12 months</time_frame>
    <description>A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale [unsatisfied (4), satisfied (3), very satisfied (2), highly satisfied (1))] of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site.&#xD;
Scores closer to 1 indicate a more favorable outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Ecchymosis Evaluation - PI</measure>
    <time_frame>6 months</time_frame>
    <description>The surface area and color of ecchymosis will be evaluated at 1 day, 1 week, 4 weeks, and 6 months following surgery.&#xD;
Rating Extent Color 0 No ecchymosis No color change&#xD;
Up to medial one-third of the lower and/or up eyelid Yellowish color change&#xD;
Medial half of the upper and/or lower eyelid Light purple&#xD;
Entire upper and/or lower eyelid Dark purple&#xD;
Entire part of the lower and upper eyelid and/or conjunctiva Very dark purple&#xD;
Extension of ecchymosis below the malar bone&#xD;
Scores closer to 0 indicate a more favorable outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subjective Ecchymosis Evaluation - Subject</measure>
    <time_frame>6 months</time_frame>
    <description>Ecchymosis will be determined by a live assessment at 1 day, 1 week, 4 weeks and 6 months following surgery using a six-point categorical edema scale.&#xD;
Rating Extent Color 0 No ecchymosis No color change&#xD;
Up to medial one-third of the lower and/or up eyelid Yellowish color change&#xD;
Medial half of the upper and/or lower eyelid Light purple&#xD;
Entire upper and/or lower eyelid Dark purple&#xD;
Entire part of the lower and upper eyelid and/or conjunctiva Very dark purple&#xD;
Extension of ecchymosis below the malar bone</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Day 30</time_frame>
    <description>Subjects will complete a 30-day diary documenting adverse events such as erythema, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching and numbness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject Downtime Questionnaire</measure>
    <time_frame>1 day, 1 week, 4 weeks and 6 months following surgery</time_frame>
    <description>Subject downtime will be determined using a questionnaire at 1 day, 1 week, 4 weeks, and 6 months following surgery.&#xD;
Responders are defined as those subjects experiencing little to no downtime.&#xD;
Downtime scale:&#xD;
(3) Very Much (2) A Lot&#xD;
(1) A Little (0) Not at all&#xD;
Scores closer to 0 indicate more favorable outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HPSS Assessment</measure>
    <time_frame>1 week, 4 weeks and 6 months following surgery</time_frame>
    <description>Changes in subject self-esteem will be determined by subject completion of the Heatherton &amp; Polivy State Self-Esteem (HPSS) Scale at 1 week, 4 weeks and 6 months following surgery.&#xD;
HPSS: scored between 1-5 for 20 questions with a total possible score between 20-100&#xD;
- Not at all&#xD;
- A little bit&#xD;
- Somewhat&#xD;
- Very much&#xD;
- Extremely&#xD;
Scores closer to 100 indicate a more favorable outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of Use</measure>
    <time_frame>Immediately Post Surgery</time_frame>
    <description>Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease.&#xD;
(10) - Very diffiucult - (100) - Very easy&#xD;
Scores closer to 100 indicate a more favorable outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Subjects Requesting and Requiring an Open Rhinoplasty</condition>
  <arm_group>
    <arm_group_label>ARTISS Human Fibrin Sealant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ARTISS human fibrin sealant</intervention_name>
    <arm_group_label>ARTISS Human Fibrin Sealant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females between 18 and 65 years of age.&#xD;
&#xD;
          2. Subjects requesting primary rhinoplasty and requiring an external approach.&#xD;
&#xD;
          3. Subjects willing to undergo treatment with fibrin sealant.&#xD;
&#xD;
          4. Willingness and ability to comply with protocol requirements, including returning for&#xD;
             follow-up visits and abstaining from exclusionary procedures for the duration of the&#xD;
             study.&#xD;
&#xD;
          5. Willingness and ability to comply with the PI's standard preoperative and&#xD;
             postoperative rhinoplasty instructions.&#xD;
&#xD;
          6. Subjects of childbearing potential must have a negative urine pregnancy test result at&#xD;
             Visit 1 and be willing able to use an acceptable method of birth control (e.g.,&#xD;
             barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical&#xD;
             sterilization, abstinence) during the study. Women will not be considered of&#xD;
             childbearing potential if one of the following is documented on the medical history:&#xD;
&#xD;
               -  postmenopausal for at least 12 months prior to study drug administration&#xD;
&#xD;
               -  without a uterus and/or both ovaries&#xD;
&#xD;
               -  has had a bilateral tubal ligation for at least 6 months prior to study drug&#xD;
                  administration.&#xD;
&#xD;
               -  absence of an other physical condition according to the PI's discretion&#xD;
&#xD;
          7. Willingness and ability to provide written photo consent and adherence to photography&#xD;
             procedures (i.e., removal of jewelry and makeup).&#xD;
&#xD;
          8. Willingness and ability to provide written informed consent prior to performance of&#xD;
             any study related procedure.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a&#xD;
             reliable form of birth control.&#xD;
&#xD;
          2. Subjects who are planning a concurrent facial surgery during the operation (eg&#xD;
             forehead plasty, blepharoplasty, rhinoplasty, buccal fat removal, any filler&#xD;
             injections including fat injections, lip augmentation, skin resurfacing procedures&#xD;
             etc.).&#xD;
&#xD;
          3. Subjects with a previous history of rhinoplasty.&#xD;
&#xD;
          4. Subjects with a current history of smoking.&#xD;
&#xD;
          5. Subjects with a previous history of a bleeding or coagulation disorder .&#xD;
&#xD;
          6. Subject with a previous history of a vascular disorder, cardiovascular disease, and/or&#xD;
             uncontrolled hypertension.&#xD;
&#xD;
          7. Subjects a previous history of diabetes mellitus with glycosylated hemoglobin (HbA1c)&#xD;
             &gt; 7.&#xD;
&#xD;
          8. Subjects undergoing active treatment for a malignancy.&#xD;
&#xD;
          9. Subjects with a previous history of has a connective tissue disorder.&#xD;
&#xD;
         10. Subjects with active or chronic skin disorder.&#xD;
&#xD;
         11. Subjects with a previous history of Bell's palsy.&#xD;
&#xD;
         12. Subjects with a previous history of pathologically or pharmacologically induced immune&#xD;
             deficiency.&#xD;
&#xD;
         13. Subjects who have received chronic treatment with immunosuppressive drugs, systemic&#xD;
             corticosteroids, or other chronic treatments within 30 days prior to the surgery.&#xD;
&#xD;
         14. Subjects with a known sensitivity to components of FS VH S/D 4 s-apr.&#xD;
&#xD;
         15. Subjects with a previous history of healing complications following previous surgeries&#xD;
             (eg, hypertrophic scarring).&#xD;
&#xD;
         16. Subjects with a significant systemic illness or illness localized to the areas of&#xD;
             treatment.&#xD;
&#xD;
         17. Subjects with previous history of nasal implants.&#xD;
&#xD;
         18. Subjects with previous or current history of nasal infections.&#xD;
&#xD;
         19. Subjects who have history of blood thinners (aspirin, ibuprofen, naprosyn, herbal&#xD;
             supplements, Vitamin E) within the two weeks prior to surgery.&#xD;
&#xD;
         20. Subjects who have smoked within the two weeks prior to surgery.&#xD;
&#xD;
         21. Subjects who have had alcohol or illicit drugs one week prior to surgery.&#xD;
&#xD;
         22. Subjects who have eaten or drank anything after midnight the night prior to surgery.&#xD;
&#xD;
         23. Subjects with current history of chronic drug or alcohol abuse.&#xD;
&#xD;
         24. Concurrent therapy that, in the investigator's opinion, would interfere with the&#xD;
             evaluation of the safety or efficacy of the study medication.&#xD;
&#xD;
         25. Subjects who anticipate the need for surgery, other than the study procedure, or&#xD;
             overnight hospitalization during the study.&#xD;
&#xD;
         26. Subjects who, in the Investigator's opinion, have a history of poor cooperation, non&#xD;
             compliance with medical treatment or unreliability.&#xD;
&#xD;
         27. Subject has participated in another clinical study involving an investigational&#xD;
             product/device within 30 days prior to enrollment or is scheduled to participate in&#xD;
             another clinical study involving an investigational product/device during the course&#xD;
             of this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven H Dayan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>DeNova Research</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>DeNova Research</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.denovaresearch.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <results_first_submitted>August 11, 2020</results_first_submitted>
  <results_first_submitted_qc>September 18, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 14, 2020</results_first_posted>
  <last_update_submitted>October 12, 2020</last_update_submitted>
  <last_update_submitted_qc>October 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>DeNova Research</investigator_affiliation>
    <investigator_full_name>Steven H. Dayan</investigator_full_name>
    <investigator_title>Medical Director</investigator_title>
  </responsible_party>
  <keyword>rhinoplasty</keyword>
  <keyword>external rhinoplasty</keyword>
  <keyword>open rhinoplasty</keyword>
  <keyword>nose job</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibrin Tissue Adhesive</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ARTISS Human Fibrin Sealant</title>
          <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care</title>
          <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ARTISS Human Fibrin Sealant</title>
          <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care</title>
          <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</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="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="10"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="45.3" lower_limit="18" upper_limit="50"/>
                    <measurement group_id="B2" value="45.3" lower_limit="18" upper_limit="50"/>
                    <measurement group_id="B3" value="45.3" lower_limit="18" upper_limit="50"/>
                  </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="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Edema Severity</title>
        <description>Measured at Day 1, 7, 30, 180&#xD;
0 None- No apparent edema&#xD;
Mild- Minimal tissue swelling&#xD;
Moderate- Moderate edema, nasal features still discernible&#xD;
Severe- Marked swelling, difficulty distinguishing nasal features&#xD;
Scores closer to 0 indicate more favorable results</description>
        <time_frame>Measured at Day 1, 7, 30, 180</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARTISS Human Fibrin Sealant</title>
            <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Edema Severity</title>
          <description>Measured at Day 1, 7, 30, 180&#xD;
0 None- No apparent edema&#xD;
Mild- Minimal tissue swelling&#xD;
Moderate- Moderate edema, nasal features still discernible&#xD;
Severe- Marked swelling, difficulty distinguishing nasal features&#xD;
Scores closer to 0 indicate more favorable results</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" spread="1.5"/>
                    <measurement group_id="O2" value="1.5" spread="1.291"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" spread="1.5"/>
                    <measurement group_id="O2" value="1" spread="1.155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 30</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="0.816"/>
                    <measurement group_id="O2" value="1" spread="1.414"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 180</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.25" spread="1.5"/>
                    <measurement group_id="O2" value="0.5" spread="0.577"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Median Number of Adverse Events</title>
        <description>Safety will be assessed by the incidence of AEs throughout the study period as documented by clinician observations at study visits and in a 30-day subject diary.</description>
        <time_frame>1 day, 1 week, 4 weeks and 6 months following surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARTISS Human Fibrin Sealant</title>
            <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Median Number of Adverse Events</title>
          <description>Safety will be assessed by the incidence of AEs throughout the study period as documented by clinician observations at study visits and in a 30-day subject diary.</description>
          <units>number of AE's</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="6"/>
                    <measurement group_id="O2" value="10" lower_limit="8" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Blinded-assessment of Satisfaction</title>
        <description>A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale [unsatisfied (4), satisfied (3), very satisfied (2), highly satisfied (1))] of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site.&#xD;
Scores closer to 1 indicate a more favorable outcome</description>
        <time_frame>Measured at Baseline, 1 month, 3 months, 6 months, 12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARTISS Human Fibrin Sealant</title>
            <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Blinded-assessment of Satisfaction</title>
          <description>A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale [unsatisfied (4), satisfied (3), very satisfied (2), highly satisfied (1))] of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site.&#xD;
Scores closer to 1 indicate a more favorable outcome</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="0"/>
                    <measurement group_id="O2" value="4" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="0.894"/>
                    <measurement group_id="O2" value="2" spread="0.816"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" spread="0"/>
                    <measurement group_id="O2" value="1" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="0.894"/>
                    <measurement group_id="O2" value="1.33" spread="0.577"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="0.707"/>
                    <measurement group_id="O2" value="2" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Objective Ecchymosis Evaluation - PI</title>
        <description>The surface area and color of ecchymosis will be evaluated at 1 day, 1 week, 4 weeks, and 6 months following surgery.&#xD;
Rating Extent Color 0 No ecchymosis No color change&#xD;
Up to medial one-third of the lower and/or up eyelid Yellowish color change&#xD;
Medial half of the upper and/or lower eyelid Light purple&#xD;
Entire upper and/or lower eyelid Dark purple&#xD;
Entire part of the lower and upper eyelid and/or conjunctiva Very dark purple&#xD;
Extension of ecchymosis below the malar bone&#xD;
Scores closer to 0 indicate a more favorable outcome.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARTISS Human Fibrin Sealant</title>
            <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Objective Ecchymosis Evaluation - PI</title>
          <description>The surface area and color of ecchymosis will be evaluated at 1 day, 1 week, 4 weeks, and 6 months following surgery.&#xD;
Rating Extent Color 0 No ecchymosis No color change&#xD;
Up to medial one-third of the lower and/or up eyelid Yellowish color change&#xD;
Medial half of the upper and/or lower eyelid Light purple&#xD;
Entire upper and/or lower eyelid Dark purple&#xD;
Entire part of the lower and upper eyelid and/or conjunctiva Very dark purple&#xD;
Extension of ecchymosis below the malar bone&#xD;
Scores closer to 0 indicate a more favorable outcome.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="1"/>
                    <measurement group_id="O2" value="1.5" spread="0.577"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="0.548"/>
                    <measurement group_id="O2" value="0.75" spread="0.957"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subjective Ecchymosis Evaluation - Subject</title>
        <description>Ecchymosis will be determined by a live assessment at 1 day, 1 week, 4 weeks and 6 months following surgery using a six-point categorical edema scale.&#xD;
Rating Extent Color 0 No ecchymosis No color change&#xD;
Up to medial one-third of the lower and/or up eyelid Yellowish color change&#xD;
Medial half of the upper and/or lower eyelid Light purple&#xD;
Entire upper and/or lower eyelid Dark purple&#xD;
Entire part of the lower and upper eyelid and/or conjunctiva Very dark purple&#xD;
Extension of ecchymosis below the malar bone</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARTISS Human Fibrin Sealant</title>
            <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Subjective Ecchymosis Evaluation - Subject</title>
          <description>Ecchymosis will be determined by a live assessment at 1 day, 1 week, 4 weeks and 6 months following surgery using a six-point categorical edema scale.&#xD;
Rating Extent Color 0 No ecchymosis No color change&#xD;
Up to medial one-third of the lower and/or up eyelid Yellowish color change&#xD;
Medial half of the upper and/or lower eyelid Light purple&#xD;
Entire upper and/or lower eyelid Dark purple&#xD;
Entire part of the lower and upper eyelid and/or conjunctiva Very dark purple&#xD;
Extension of ecchymosis below the malar bone</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="1"/>
                    <measurement group_id="O2" value="2" spread="0.778"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="0.667"/>
                    <measurement group_id="O2" value="2" spread="0.816"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread="0"/>
                    <measurement group_id="O2" value="0" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events</title>
        <description>Subjects will complete a 30-day diary documenting adverse events such as erythema, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching and numbness.</description>
        <time_frame>Day 30</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARTISS Human Fibrin Sealant</title>
            <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events</title>
          <description>Subjects will complete a 30-day diary documenting adverse events such as erythema, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching and numbness.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Subject Downtime Questionnaire</title>
        <description>Subject downtime will be determined using a questionnaire at 1 day, 1 week, 4 weeks, and 6 months following surgery.&#xD;
Responders are defined as those subjects experiencing little to no downtime.&#xD;
Downtime scale:&#xD;
(3) Very Much (2) A Lot&#xD;
(1) A Little (0) Not at all&#xD;
Scores closer to 0 indicate more favorable outcome</description>
        <time_frame>1 day, 1 week, 4 weeks and 6 months following surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARTISS Human Fibrin Sealant</title>
            <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Subject Downtime Questionnaire</title>
          <description>Subject downtime will be determined using a questionnaire at 1 day, 1 week, 4 weeks, and 6 months following surgery.&#xD;
Responders are defined as those subjects experiencing little to no downtime.&#xD;
Downtime scale:&#xD;
(3) Very Much (2) A Lot&#xD;
(1) A Little (0) Not at all&#xD;
Scores closer to 0 indicate more favorable outcome</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.864"/>
                    <measurement group_id="O2" value="4" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="0.447"/>
                    <measurement group_id="O2" value="3.25" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.14"/>
                    <measurement group_id="O2" value="2" spread="0.816"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.447"/>
                    <measurement group_id="O2" value="1" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>HPSS Assessment</title>
        <description>Changes in subject self-esteem will be determined by subject completion of the Heatherton &amp; Polivy State Self-Esteem (HPSS) Scale at 1 week, 4 weeks and 6 months following surgery.&#xD;
HPSS: scored between 1-5 for 20 questions with a total possible score between 20-100&#xD;
- Not at all&#xD;
- A little bit&#xD;
- Somewhat&#xD;
- Very much&#xD;
- Extremely&#xD;
Scores closer to 100 indicate a more favorable outcome</description>
        <time_frame>1 week, 4 weeks and 6 months following surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARTISS Human Fibrin Sealant</title>
            <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>HPSS Assessment</title>
          <description>Changes in subject self-esteem will be determined by subject completion of the Heatherton &amp; Polivy State Self-Esteem (HPSS) Scale at 1 week, 4 weeks and 6 months following surgery.&#xD;
HPSS: scored between 1-5 for 20 questions with a total possible score between 20-100&#xD;
- Not at all&#xD;
- A little bit&#xD;
- Somewhat&#xD;
- Very much&#xD;
- Extremely&#xD;
Scores closer to 100 indicate a more favorable outcome</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="0.447"/>
                    <measurement group_id="O2" value="3.25" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.14"/>
                    <measurement group_id="O2" value="2" spread="0.816"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="0.447"/>
                    <measurement group_id="O2" value="1" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ease of Use</title>
        <description>Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease.&#xD;
(10) - Very diffiucult - (100) - Very easy&#xD;
Scores closer to 100 indicate a more favorable outcome</description>
        <time_frame>Immediately Post Surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ARTISS Human Fibrin Sealant</title>
            <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care</title>
            <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
          </group>
        </group_list>
        <measure>
          <title>Ease of Use</title>
          <description>Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease.&#xD;
(10) - Very diffiucult - (100) - Very easy&#xD;
Scores closer to 100 indicate a more favorable outcome</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.6" spread="5.225"/>
                    <measurement group_id="O2" value="39" spread="17.682"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>ARTISS Human Fibrin Sealant</title>
          <description>Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.&#xD;
ARTISS human fibrin sealant</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care</title>
          <description>Fixation of the skin flap created during external rhinoplasty will use the standard of care</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="4"/>
              </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="1" subjects_at_risk="5"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <description>A discoloration of the skin resulting from bleeding underneath, typically caused by bruising</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="5"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Steven Dayan, MD</name_or_title>
      <organization>DeNova Research</organization>
      <phone>3123352070</phone>
      <email>sdayan@drdayan.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/NCT01684020
org study id: ART-RHI-12
nct id: NCT01684020
lead sponsor: 
collaborator: 
has dmc: No
Rhinoplasty (nasal reconstruction i.e. "a nose job") is a surgical procedure performed on the
      nose to correct a medical problem or change the appearance of the nose. During the healing
      process, swelling and/or bruising is likely to occur. A drug called ARTISS Fibrin Sealant may
      or may not lessen these effects. This study is looking to see the effects of ARTISS on
      adhering tissue and improving wound healing in an external rhinoplasty. The purpose of this
      study is to evaluate the safety and effectiveness of rhinoplasty using ARTISS compared to
      rhinoplasty without using ARTISS in patients undergoing rhinoplasty performed through an
      external approach.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Edema Severity
time frame: Measured at Day 1, 7, 30, 180
description: Measured at Day 1, 7, 30, 180
0 None- No apparent edema
Mild- Minimal tissue swelling
Moderate- Moderate edema, nasal features still discernible
Severe- Marked swelling, difficulty distinguishing nasal features
Scores closer to 0 indicate more favorable results
measure: Median Number of Adverse Events
time frame: 1 day, 1 week, 4 weeks and 6 months following surgery
description: Safety will be assessed by the incidence of AEs throughout the study period as documented by clinician observations at study visits and in a 30-day subject diary.
measure: Blinded-assessment of Satisfaction
time frame: Measured at Baseline, 1 month, 3 months, 6 months, 12 months
description: A non-treating blinded evaluator will assess satisfaction with a four-point categorical satisfaction scale [unsatisfied (4), satisfied (3), very satisfied (2), highly satisfied (1))] of subject's grafts using photographs from baseline, 1 month, 3 months, 6 months, and 12 months and will consist of a blinded evaluation in which the physician is aware of the type of graft, but unaware of plating status or the specific grafting site.
Scores closer to 1 indicate a more favorable outcome
measure: Objective Ecchymosis Evaluation - PI
time frame: 6 months
description: The surface area and color of ecchymosis will be evaluated at 1 day, 1 week, 4 weeks, and 6 months following surgery.
Rating Extent Color 0 No ecchymosis No color change
Up to medial one-third of the lower and/or up eyelid Yellowish color change
Medial half of the upper and/or lower eyelid Light purple
Entire upper and/or lower eyelid Dark purple
Entire part of the lower and upper eyelid and/or conjunctiva Very dark purple
Extension of ecchymosis below the malar bone
Scores closer to 0 indicate a more favorable outcome.
measure: Subjective Ecchymosis Evaluation - Subject
time frame: 6 months
description: Ecchymosis will be determined by a live assessment at 1 day, 1 week, 4 weeks and 6 months following surgery using a six-point categorical edema scale.
Rating Extent Color 0 No ecchymosis No color change
Up to medial one-third of the lower and/or up eyelid Yellowish color change
Medial half of the upper and/or lower eyelid Light purple
Entire upper and/or lower eyelid Dark purple
Entire part of the lower and upper eyelid and/or conjunctiva Very dark purple
Extension of ecchymosis below the malar bone
measure: Number of Participants With Adverse Events
time frame: Day 30
description: Subjects will complete a 30-day diary documenting adverse events such as erythema, pain, tenderness, firmness, swelling, lumps/bumps, bruising, itching and numbness.
measure: Subject Downtime Questionnaire
time frame: 1 day, 1 week, 4 weeks and 6 months following surgery
description: Subject downtime will be determined using a questionnaire at 1 day, 1 week, 4 weeks, and 6 months following surgery.
Responders are defined as those subjects experiencing little to no downtime.
Downtime scale:
(3) Very Much (2) A Lot
(1) A Little (0) Not at all
Scores closer to 0 indicate more favorable outcome
measure: HPSS Assessment
time frame: 1 week, 4 weeks and 6 months following surgery
description: Changes in subject self-esteem will be determined by subject completion of the Heatherton & Polivy State Self-Esteem (HPSS) Scale at 1 week, 4 weeks and 6 months following surgery.
HPSS: scored between 1-5 for 20 questions with a total possible score between 20-100
- Not at all
- A little bit
- Somewhat
- Very much
- Extremely
Scores closer to 100 indicate a more favorable outcome
measure: Ease of Use
time frame: Immediately Post Surgery
description: Ease of use will be determined by the treating investigator using a 10 cm Visual Analog Scale (VAS) to demonstrate technical ease.
(10) - Very diffiucult - (100) - Very easy
Scores closer to 100 indicate a more favorable outcome
arm group label: ARTISS Human Fibrin Sealant
arm group type: Experimental
description: Prior to fixation of the external rhinoplasty skin flap, a thin layer of ARTISS human fibrin sealant will be applied over the nasal tissue and fixated to the skin flap for at least 3 minutes.
arm group label: Standard of Care
arm group type: No Intervention
description: Fixation of the skin flap created during external rhinoplasty will use the standard of care
intervention type: Biological
intervention name: ARTISS human fibrin sealant
arm group label: ARTISS Human Fibrin Sealant
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Steven H Dayan, MD
role: Principal Investigator
affiliation: DeNova Research
facility: 
country: United States
url: http://www.denovaresearch.com
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: DeNova Research
investigator full name: Steven H. Dayan
investigator title: Medical Director
mesh term: Fibrin Tissue Adhesive
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 