<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/NCT03748459</url>
  </required_header>
  <id_info>
    <org_study_id>00066546</org_study_id>
    <nct_id>NCT03748459</nct_id>
  </id_info>
  <brief_title>Rhinoplasty Scar Comparison</brief_title>
  <official_title>Patient and Observer Graded Rhinoplasty Scar Outcomes: A Randomized-Controlled Trial of Fast Absorbing Versus Permanent Columellar Suture Closure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traditional suture closure of the columellar scar in rhinoplasty is achieved with permanent&#xD;
      skin sutures. These sutures create less inflammation and are thought to lead to improved&#xD;
      final scar outcomes. However, permanent sutures require removal which creates pain and&#xD;
      inconvenience for the patient. Some surgeons use fast absorbing sutures that do not require&#xD;
      removal. The difference in final scar outcome based on suture material used has not been well&#xD;
      studied. This study will examine the final scar outcomes of rhinoplasty incisions sutured&#xD;
      with traditional permanent suture compared to fast absorbing suture. If scar outcomes are&#xD;
      similar between these groups as judged by the patients and blinded observers, rhinoplasty&#xD;
      surgeons may be able to preferentially utilize absorbable sutures for incision closure and&#xD;
      avoid the pain and inconvenience for the patient during suture removal&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2017</start_date>
  <completion_date type="Actual">September 14, 2020</completion_date>
  <primary_completion_date type="Actual">September 14, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Scar Assessment</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Patient scar assessment will be done with a patient completed questionnaire. The questionnaire is a validated scar assessment instrument for self rating of surgical scars by patients for a minimum rating of 28 (best scar) to 112 (worst scar)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinician Scar Assessment</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Clinician scar assessment will be done using photographs of the scar 12 months after surgery. Clinicians will use a validated clinician scar grading tool for evaluation of surgical scars with a range of 0 (worst scar) to 5 (best scar)</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Surgical Incision</condition>
  <condition>Nose Deformity</condition>
  <arm_group>
    <arm_group_label>Permanent suture</arm_group_label>
    <description>Subjects will have skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resorbable suture</arm_group_label>
    <description>Subjects will have skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Closure with Permanent Suture</intervention_name>
    <description>Skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.</description>
    <arm_group_label>Permanent suture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Closure with Resorbable Suture</intervention_name>
    <description>Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.</description>
    <arm_group_label>Resorbable suture</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients seeking rhinoplasty surgery with one of the investigators.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        •Adult (age ≥ 18 years) patients undergoing primary open rhinoplasty surgery for any reason&#xD;
        with any of the study surgeons.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Patients undergoing rhinoplasty for cleft nasal deformity or nasal reconstruction&#xD;
             related to cancer resection&#xD;
&#xD;
          -  Patients with previous surgery that involved a columellar incision. Patients with&#xD;
             history of previous nasal surgery that did not involve an incision on the columella&#xD;
             may be included&#xD;
&#xD;
          -  Patients with known history of cutaneous disorder that affects scaring such as&#xD;
             personal history of keloid formation, collagen vascular disease, or previous radiation&#xD;
             to the surgical site&#xD;
&#xD;
          -  Inability or unwillingness of subject to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ralph Johnson VA Medical Center</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 20, 2018</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
    <investigator_full_name>Samuel Oyer</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03748459
org study id: 00066546
nct id: NCT03748459
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Traditional suture closure of the columellar scar in rhinoplasty is achieved with permanent
      skin sutures. These sutures create less inflammation and are thought to lead to improved
      final scar outcomes. However, permanent sutures require removal which creates pain and
      inconvenience for the patient. Some surgeons use fast absorbing sutures that do not require
      removal. The difference in final scar outcome based on suture material used has not been well
      studied. This study will examine the final scar outcomes of rhinoplasty incisions sutured
      with traditional permanent suture compared to fast absorbing suture. If scar outcomes are
      similar between these groups as judged by the patients and blinded observers, rhinoplasty
      surgeons may be able to preferentially utilize absorbable sutures for incision closure and
      avoid the pain and inconvenience for the patient during suture removal
observational model: Case-Control
time perspective: Prospective
measure: Patient Scar Assessment
time frame: 12 months after surgery
description: Patient scar assessment will be done with a patient completed questionnaire. The questionnaire is a validated scar assessment instrument for self rating of surgical scars by patients for a minimum rating of 28 (best scar) to 112 (worst scar)
measure: Clinician Scar Assessment
time frame: 12 months after surgery
description: Clinician scar assessment will be done using photographs of the scar 12 months after surgery. Clinicians will use a validated clinician scar grading tool for evaluation of surgical scars with a range of 0 (worst scar) to 5 (best scar)
arm group label: Permanent suture
description: Subjects will have skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.
arm group label: Resorbable suture
description: Subjects will have skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty
intervention type: Other
intervention name: Closure with Permanent Suture
description: Skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.
arm group label: Permanent suture
intervention type: Other
intervention name: Closure with Resorbable Suture
description: Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.
arm group label: Resorbable suture
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Samuel Oyer
investigator title: Assistant Professor
mesh term: Surgical Wound