<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/NCT03303027</url>
  </required_header>
  <id_info>
    <org_study_id>902404</org_study_id>
    <nct_id>NCT03303027</nct_id>
  </id_info>
  <brief_title>6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Wound Closure</brief_title>
  <official_title>Use of 6-0 Fast Absorbing Gut Versus 5-0 Fast Absorbing Gut for Linear Cutaneous Wound Closure: a Randomized Evaluator Blind Split Wound Comparative Effectiveness Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Davis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traditionally, dermatologic surgeons close wounds with stitches. Fast absorbing gut is a&#xD;
      dissolvable stitch that is very commonly used. Some surgeons believe that using a thinner&#xD;
      size of this stitch causes less skin reaction and improves the cosmetic outcome of the scar.&#xD;
      Other surgeons believe that using a thicker size of this stitch reduces the tension on the&#xD;
      scar and improves the cosmetic outcome of the scar in that manner. The investigator wishes to&#xD;
      determine whether the thickness of the fast absorbing gut suture that is used makes a&#xD;
      difference in the cosmetic outcome of the scar.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to determine whether the use of 6-0 fast absorbing gut during&#xD;
      repair of linear cutaneous surgery wounds on the face or neck improves scar cosmesis compared&#xD;
      to wound closure with 5-0 fast absorbing gut. The investigator will use a split wound model,&#xD;
      where half of the wound is repaired with 6-0 fast absorbing gut and the other half is&#xD;
      repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured&#xD;
      via the patient observer scar assessment scale, a validated scar instrument. The scar width,&#xD;
      and adverse events will also be recorded.&#xD;
&#xD;
      This study aims to investigate whether 5-0 versus 6-0 fast absorbing gut suture leads to&#xD;
      better surgical wound cosmesis on the head and neck. The 5-0 fast absorbing gut suture has a&#xD;
      large diameter, and therefore greater tensile strength. The greater tensile strength would&#xD;
      provide better support of the healing scar during the first 5-7 days after surgery and for&#xD;
      this reason, could potentially lead to improved scar cosmesis. However, the greater diameter&#xD;
      could also lead to track marks that are larger and more visible. Furthermore, fast absorbing&#xD;
      gut has a high degree of tissue reactivity to begin with, and it is known that larger&#xD;
      diameter sutures generate more tissue reactivity compared to smaller diameter sutures of the&#xD;
      same material; therefore, it is also possible that the 6-0 fast absorbing gut suture would&#xD;
      provide better scar cosmesis by virtue of its lower tissue reactivity3,4.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 27, 2016</start_date>
  <completion_date type="Actual">April 16, 2019</completion_date>
  <primary_completion_date type="Actual">March 21, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scar Assessment</measure>
    <time_frame>3 months following the procedure</time_frame>
    <description>The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Width of the Scar</measure>
    <time_frame>3 months following the procedure</time_frame>
    <description>The secondary endpoints will include the width of the scar 1 cm from midline on each side at the follow-up visit and any complications from the treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Surgical Wound Cosmesis</condition>
  <arm_group>
    <arm_group_label>6-0 fast absorbing gut suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6-0 fast absorbing gut used to suture wound</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5-0 fast absorbing gut suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5-0 fast absorbing gut used to suture wound</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>6-0 fast absorbing gut suture</intervention_name>
    <description>Fast absorbing surgical gut suture is a strand of collagenous material, size 6-0</description>
    <arm_group_label>6-0 fast absorbing gut suture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>5-0 fast absorbing gut suture</intervention_name>
    <description>Fast absorbing surgical gut suture is a strand of collagenous material, size 5-0</description>
    <arm_group_label>5-0 fast absorbing gut suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Able to give informed consent themselves&#xD;
&#xD;
          -  Patient scheduled for cutaneous surgical procedure on the head and neck with predicted&#xD;
             primary closure&#xD;
&#xD;
          -  Willing to return for follow up visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mentally handicapped&#xD;
&#xD;
          -  Unable to understand written and oral English&#xD;
&#xD;
          -  Incarceration&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Pregnant Women&#xD;
&#xD;
          -  Wounds with predicted closure length less than 3 cm&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Eisen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Davis</affiliation>
  </overall_official>
  <reference>
    <citation>Tajirian AL, Goldberg DJ. A review of sutures and other skin closure materials. J Cosmet Laser Ther. 2010 Dec;12(6):296-302. doi: 10.3109/14764172.2010.538413.</citation>
    <PMID>21142740</PMID>
  </reference>
  <reference>
    <citation>Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am. 2009 Jun;89(3):627-41. doi: 10.1016/j.suc.2009.03.001.</citation>
    <PMID>19465201</PMID>
  </reference>
  <reference>
    <citation>Gabrielli F, Potenza C, Puddu P, Sera F, Masini C, Abeni D. Suture materials and other factors associated with tissue reactivity, infection, and wound dehiscence among plastic surgery outpatients. Plast Reconstr Surg. 2001 Jan;107(1):38-45. doi: 10.1097/00006534-200101000-00007.</citation>
    <PMID>11176599</PMID>
  </reference>
  <reference>
    <citation>van Rijssel EJ, Brand R, Admiraal C, Smit I, Trimbos JB. Tissue reaction and surgical knots: the effect of suture size, knot configuration, and knot volume. Obstet Gynecol. 1989 Jul;74(1):64-8.</citation>
    <PMID>2543937</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>April 29, 2019</last_update_submitted>
  <last_update_submitted_qc>April 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cosmesis</keyword>
  <keyword>Surgical Wound</keyword>
  <keyword>Fast Absorbing Gut</keyword>
  <keyword>Linear Cutaneous Wound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
    <mesh_term>Surgical Wound</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03303027
org study id: 902404
nct id: NCT03303027
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Traditionally, dermatologic surgeons close wounds with stitches. Fast absorbing gut is a
      dissolvable stitch that is very commonly used. Some surgeons believe that using a thinner
      size of this stitch causes less skin reaction and improves the cosmetic outcome of the scar.
      Other surgeons believe that using a thicker size of this stitch reduces the tension on the
      scar and improves the cosmetic outcome of the scar in that manner. The investigator wishes to
      determine whether the thickness of the fast absorbing gut suture that is used makes a
      difference in the cosmetic outcome of the scar.
The purpose of this study is to determine whether the use of 6-0 fast absorbing gut during
      repair of linear cutaneous surgery wounds on the face or neck improves scar cosmesis compared
      to wound closure with 5-0 fast absorbing gut. The investigator will use a split wound model,
      where half of the wound is repaired with 6-0 fast absorbing gut and the other half is
      repaired with 5-0 fast absorbing gut. Three-months post-surgery, the scar will be measured
      via the patient observer scar assessment scale, a validated scar instrument. The scar width,
      and adverse events will also be recorded.

      This study aims to investigate whether 5-0 versus 6-0 fast absorbing gut suture leads to
      better surgical wound cosmesis on the head and neck. The 5-0 fast absorbing gut suture has a
      large diameter, and therefore greater tensile strength. The greater tensile strength would
      provide better support of the healing scar during the first 5-7 days after surgery and for
      this reason, could potentially lead to improved scar cosmesis. However, the greater diameter
      could also lead to track marks that are larger and more visible. Furthermore, fast absorbing
      gut has a high degree of tissue reactivity to begin with, and it is known that larger
      diameter sutures generate more tissue reactivity compared to smaller diameter sutures of the
      same material; therefore, it is also possible that the 6-0 fast absorbing gut suture would
      provide better scar cosmesis by virtue of its lower tissue reactivity3,4.
allocation: Non-Randomized
intervention model: Factorial Assignment
intervention model description: The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Scar Assessment
time frame: 3 months following the procedure
description: The primary endpoint will be the score of two blinded reviewers using the patient observer scar assessment score at a three-month assessment visit.
measure: Width of the Scar
time frame: 3 months following the procedure
description: The secondary endpoints will include the width of the scar 1 cm from midline on each side at the follow-up visit and any complications from the treatment.
arm group label: 6-0 fast absorbing gut suture
arm group type: Experimental
description: 6-0 fast absorbing gut used to suture wound
arm group label: 5-0 fast absorbing gut suture
arm group type: Experimental
description: 5-0 fast absorbing gut used to suture wound
intervention type: Device
intervention name: 6-0 fast absorbing gut suture
description: Fast absorbing surgical gut suture is a strand of collagenous material, size 6-0
arm group label: 6-0 fast absorbing gut suture
intervention type: Device
intervention name: 5-0 fast absorbing gut suture
description: Fast absorbing surgical gut suture is a strand of collagenous material, size 5-0
arm group label: 5-0 fast absorbing gut suture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Daniel Eisen, MD
role: Principal Investigator
affiliation: University of California, Davis
citation: Tajirian AL, Goldberg DJ. A review of sutures and other skin closure materials. J Cosmet Laser Ther. 2010 Dec;12(6):296-302. doi: 10.3109/14764172.2010.538413.
PMID: 21142740
citation: Hochberg J, Meyer KM, Marion MD. Suture choice and other methods of skin closure. Surg Clin North Am. 2009 Jun;89(3):627-41. doi: 10.1016/j.suc.2009.03.001.
PMID: 19465201
citation: Gabrielli F, Potenza C, Puddu P, Sera F, Masini C, Abeni D. Suture materials and other factors associated with tissue reactivity, infection, and wound dehiscence among plastic surgery outpatients. Plast Reconstr Surg. 2001 Jan;107(1):38-45. doi: 10.1097/00006534-200101000-00007.
PMID: 11176599
citation: van Rijssel EJ, Brand R, Admiraal C, Smit I, Trimbos JB. Tissue reaction and surgical knots: the effect of suture size, knot configuration, and knot volume. Obstet Gynecol. 1989 Jul;74(1):64-8.
PMID: 2543937
responsible party type: Sponsor
mesh term: Wounds and Injuries
mesh term: Surgical Wound
sharing ipd: Undecided