<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/NCT03284983</url>
  </required_header>
  <id_info>
    <org_study_id>IRB16-051</org_study_id>
    <nct_id>NCT03284983</nct_id>
  </id_info>
  <brief_title>Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing</brief_title>
  <acronym>SFD</acronym>
  <official_title>Split Scar Study to Assess Cosmetic Outcome From Differing Suture Spacing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silver Falls Dermatology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Samaritan Health Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Silver Falls Dermatology</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>
      The investigators wish to determine how suture spacing (5 mm vs. 10 mm) affects cosmetic&#xD;
      outcome and development of &quot;train tracking&quot; in wounds. Linear wounds with sutures spaced&#xD;
      closer together may not be as cosmetically appealing when compared to those that have larger&#xD;
      spacing between sutures. Suturing closer together constricts blood flow and increases tension&#xD;
      that ultimately results in more tissue necrosis and a less appealing outcome. The&#xD;
      investigators also aim to conclude if 5 mm or 10 mm suture spacing results in less&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2017</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in cosmetic outcome of 5 mm versus 10 mm suture spacing on wound healing</measure>
    <time_frame>6 months</time_frame>
    <description>The wound was divided in half by placing a single 4-0 Polysorb suture in the midpoint of the wound based on ruler measurement. Simple interrupted nylon sutures were spaced approximately 5mm or 10mm apart depending on side. The sutures were then removed at 2-week follow-up appointment. The Patient and Observer Scar Assessment Scale (POSAS) was then performed by both patient and physician. The observer scale consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area), and all items were scored on a scale from 1 ('like normal skin') to 10 ('worst scar imaginable'). The patient scale also includes six items (color, itch, pain, thickness, stiffness, and irregularity) and all items were scored on a similar scale from 1 ('like normal skin') to 10 ('worst scar imaginable').</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in wound complications of 5 mm versus 10 mm suture spacing on wound healing</measure>
    <time_frame>2 weeks</time_frame>
    <description>Wounds were also assessed for complications. Difficulty removing sutures was assessed by presence of either one of the following: unable to directly visualize suture knot or need to probe into wound to remove suture. Wound dehiscence was defined as at least a 1mm separation of the wound edge for at least 50% of the length of the wound closure. Edge necrosis was defined as eschar and necrosis of the wound edge for at least 50% of the wound closure. Infection was defined as any wound that had redness, pain and exudate.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Suture, Complication</condition>
  <condition>Wound</condition>
  <condition>Wound Complication</condition>
  <condition>Wound Dehiscence</condition>
  <condition>Wound of Skin</condition>
  <condition>Surgery</condition>
  <condition>Suture; Complications, Infection or Inflammation</condition>
  <arm_group>
    <arm_group_label>10 mm suture spacing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The investigators aim to determine how suture spacing affects cosmetic outcome of wound healing. One side (1/2 of the wound length) was sutured with 10 mm suture spacing</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Suture spacing for wound closure</intervention_name>
    <description>The wound was divided in half and sutures were spaced 5mm or 10mm apart depending on side. The sutures were removed at 2-week follow-up appointment and photographs were taken. The Patient and Observer Scar Assessment Scale (POSAS) was then performed by both patient and physician.</description>
    <arm_group_label>10 mm suture spacing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and female patients, at least 18 years of age, undergoing surgical excision of&#xD;
             biopsy-proven skin cancers on the trunk or extremities at Silver Falls Dermatology &amp;&#xD;
             Allergy outpatient clinic in Salem, Oregon. Patients with elliptical excisions with&#xD;
             length greater than 4.0 centimeters were included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with prior scars within 2.5cm of the proposed elliptical excision, failure to&#xD;
             comply with wound care instructions or failure to follow up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Lear, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Silver Falls Dermatology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>William Lear, MD</last_name>
    <phone>503 362 8385</phone>
    <email>wlear1@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Collin M Blattner, DO</last_name>
    <phone>503 362 8385</phone>
    <email>collin.blattner@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Silver Falls Dermatology</name>
      <address>
        <city>Salem</city>
        <state>Oregon</state>
        <zip>97302</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Angie Tingle, CMA</last_name>
      <email>Atingle@silverfallsderm.net</email>
    </contact>
    <investigator>
      <last_name>William Lear, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Collin M Blattner, DO</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJ. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD004287. doi: 10.1002/14651858.CD004287.pub4.</citation>
    <PMID>25431843</PMID>
  </reference>
  <reference>
    <citation>Bloemen MC, van Gerven MS, van der Wal MB, Verhaegen PD, Middelkoop E. An objective device for measuring surface roughness of skin and scars. J Am Acad Dermatol. 2011 Apr;64(4):706-15. doi: 10.1016/j.jaad.2010.03.006. Epub 2011 Jan 8.</citation>
    <PMID>21216493</PMID>
  </reference>
  <reference>
    <citation>Sagi HC, Papp S, Dipasquale T. The effect of suture pattern and tension on cutaneous blood flow as assessed by laser Doppler flowmetry in a pig model. J Orthop Trauma. 2008 Mar;22(3):171-5. doi: 10.1097/BOT.0b013e318169074c.</citation>
    <PMID>18317050</PMID>
  </reference>
  <reference>
    <citation>Braverman IM, Keh A, Goldminz D. Correlation of laser Doppler wave patterns with underlying microvascular anatomy. J Invest Dermatol. 1990 Sep;95(3):283-6. doi: 10.1111/1523-1747.ep12484917.</citation>
    <PMID>2143522</PMID>
  </reference>
  <results_reference>
    <citation>Shin TM, Bordeaux JS. How suture technique affects the cosmetic outcome of cutaneous repairs. J Drugs Dermatol. 2014 Aug;13(8):967-9.</citation>
    <PMID>25116976</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT03284983
org study id: IRB16-051
nct id: NCT03284983
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators wish to determine how suture spacing (5 mm vs. 10 mm) affects cosmetic
      outcome and development of "train tracking" in wounds. Linear wounds with sutures spaced
      closer together may not be as cosmetically appealing when compared to those that have larger
      spacing between sutures. Suturing closer together constricts blood flow and increases tension
      that ultimately results in more tissue necrosis and a less appealing outcome. The
      investigators also aim to conclude if 5 mm or 10 mm suture spacing results in less
      complications.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in cosmetic outcome of 5 mm versus 10 mm suture spacing on wound healing
time frame: 6 months
description: The wound was divided in half by placing a single 4-0 Polysorb suture in the midpoint of the wound based on ruler measurement. Simple interrupted nylon sutures were spaced approximately 5mm or 10mm apart depending on side. The sutures were then removed at 2-week follow-up appointment. The Patient and Observer Scar Assessment Scale (POSAS) was then performed by both patient and physician. The observer scale consists of six items (vascularity, pigmentation, thickness, relief, pliability and surface area), and all items were scored on a scale from 1 ('like normal skin') to 10 ('worst scar imaginable'). The patient scale also includes six items (color, itch, pain, thickness, stiffness, and irregularity) and all items were scored on a similar scale from 1 ('like normal skin') to 10 ('worst scar imaginable').
measure: Change in wound complications of 5 mm versus 10 mm suture spacing on wound healing
time frame: 2 weeks
description: Wounds were also assessed for complications. Difficulty removing sutures was assessed by presence of either one of the following: unable to directly visualize suture knot or need to probe into wound to remove suture. Wound dehiscence was defined as at least a 1mm separation of the wound edge for at least 50% of the length of the wound closure. Edge necrosis was defined as eschar and necrosis of the wound edge for at least 50% of the wound closure. Infection was defined as any wound that had redness, pain and exudate.
arm group label: 10 mm suture spacing
arm group type: Experimental
description: The investigators aim to determine how suture spacing affects cosmetic outcome of wound healing. One side (1/2 of the wound length) was sutured with 10 mm suture spacing
intervention type: Other
intervention name: Suture spacing for wound closure
description: The wound was divided in half and sutures were spaced 5mm or 10mm apart depending on side. The sutures were removed at 2-week follow-up appointment and photographs were taken. The Patient and Observer Scar Assessment Scale (POSAS) was then performed by both patient and physician.
arm group label: 10 mm suture spacing
criteria: 
gender: All
minimum age: 30 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William Lear, MD
role: Principal Investigator
affiliation: Silver Falls Dermatology
last name: William Lear, MD
phone: 503 362 8385
email: wlear1@gmail.com
last name: Collin M Blattner, DO
phone: 503 362 8385
email: collin.blattner@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: United States
citation: Dumville JC, Coulthard P, Worthington HV, Riley P, Patel N, Darcey J, Esposito M, van der Elst M, van Waes OJ. Tissue adhesives for closure of surgical incisions. Cochrane Database Syst Rev. 2014 Nov 28;2014(11):CD004287. doi: 10.1002/14651858.CD004287.pub4.
PMID: 25431843
citation: Bloemen MC, van Gerven MS, van der Wal MB, Verhaegen PD, Middelkoop E. An objective device for measuring surface roughness of skin and scars. J Am Acad Dermatol. 2011 Apr;64(4):706-15. doi: 10.1016/j.jaad.2010.03.006. Epub 2011 Jan 8.
PMID: 21216493
citation: Sagi HC, Papp S, Dipasquale T. The effect of suture pattern and tension on cutaneous blood flow as assessed by laser Doppler flowmetry in a pig model. J Orthop Trauma. 2008 Mar;22(3):171-5. doi: 10.1097/BOT.0b013e318169074c.
PMID: 18317050
citation: Braverman IM, Keh A, Goldminz D. Correlation of laser Doppler wave patterns with underlying microvascular anatomy. J Invest Dermatol. 1990 Sep;95(3):283-6. doi: 10.1111/1523-1747.ep12484917.
PMID: 2143522
citation: Shin TM, Bordeaux JS. How suture technique affects the cosmetic outcome of cutaneous repairs. J Drugs Dermatol. 2014 Aug;13(8):967-9.
PMID: 25116976
responsible party type: Sponsor
mesh term: Inflammation
mesh term: Wounds and Injuries
sharing ipd: Undecided