<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/NCT03781141</url>
  </required_header>
  <id_info>
    <org_study_id>18-004267</org_study_id>
    <nct_id>NCT03781141</nct_id>
  </id_info>
  <brief_title>Wound Closure Study in Carpal Tunnel and Trigger Finger Surgery</brief_title>
  <official_title>Absorbable Versus Non-Absorbable Suture in Carpal Tunnel and Trigger Finger Wound Closure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Does a difference in patient satisfaction and cosmetic outcome exist between wound closure&#xD;
      with absorbable or non-absorbable sutures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will involve randomizing patients to wound closure with absorbable or&#xD;
      non-absorbable sutures. We will if scar formation (symptoms and aesthetics) if different&#xD;
      between the two types of closures as determined by the patient and observer scar assessment&#xD;
      scale version 2.0 (POSAS) and the patient-rated wrist/hand evaluation (PRWHE), between&#xD;
      absorbable and non-absorbable suture for wound closure of open carpal tunnel release and&#xD;
      trigger finger pulley release.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2024</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blinded assessment for wound healing</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Scar formation with the Patient and Observer Scare Assessment Scale</measure>
    <time_frame>1 year</time_frame>
    <description>Blinded scar assessment utilizing the patient and observer scar assessment scale version 2.0 (POSAS).&#xD;
The POSAS is scored from the perspective of the patient and a blinded observer independently. Scores range from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable. The 1 to 10 scoring is performed in 6 domains of various scar characteristics to obtain a total score ranging from 10 to 60. Additionally, there is an overall scar appearance score that ranges from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Carpal Tunnel Syndrome</condition>
  <condition>Trigger Finger</condition>
  <arm_group>
    <arm_group_label>Absorbable suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Wound closure with absorbable suture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-absorbable suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Wound closure with non-absorbable suture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Wound closure</intervention_name>
    <description>Comparison of two wound closures</description>
    <arm_group_label>Absorbable suture</arm_group_label>
    <arm_group_label>Non-absorbable suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient greater than or equal to 18 years of age.&#xD;
&#xD;
          -  Any patient undergoing primary open carpal tunnel release or primary trigger finger&#xD;
             pulley release&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient identified outside of the proposed study time period.&#xD;
&#xD;
          -  Any patient receiving revision surgery&#xD;
&#xD;
          -  Patients who have had prior ipsilateral palmar or finger surgery&#xD;
&#xD;
          -  Patients with Dupuytren's disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter C Rhee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peter Rhee, DO</last_name>
      <phone>507-284-3664</phone>
      <email>rhee.peter@mayo.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>January 23, 2023</last_update_submitted>
  <last_update_submitted_qc>January 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Peter C. Rhee</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Trigger Finger Disorder</mesh_term>
    <mesh_term>Carpal Tunnel Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03781141
org study id: 18-004267
nct id: NCT03781141
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Does a difference in patient satisfaction and cosmetic outcome exist between wound closure
      with absorbable or non-absorbable sutures.
The study will involve randomizing patients to wound closure with absorbable or
      non-absorbable sutures. We will if scar formation (symptoms and aesthetics) if different
      between the two types of closures as determined by the patient and observer scar assessment
      scale version 2.0 (POSAS) and the patient-rated wrist/hand evaluation (PRWHE), between
      absorbable and non-absorbable suture for wound closure of open carpal tunnel release and
      trigger finger pulley release.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Blinded assessment for wound healing
measure: Scar formation with the Patient and Observer Scare Assessment Scale
time frame: 1 year
description: Blinded scar assessment utilizing the patient and observer scar assessment scale version 2.0 (POSAS).
The POSAS is scored from the perspective of the patient and a blinded observer independently. Scores range from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable. The 1 to 10 scoring is performed in 6 domains of various scar characteristics to obtain a total score ranging from 10 to 60. Additionally, there is an overall scar appearance score that ranges from 1 to 10 with 1 indicating normal skin and 10 indicating the worst scar imaginable.
arm group label: Absorbable suture
arm group type: Experimental
description: Wound closure with absorbable suture.
arm group label: Non-absorbable suture
arm group type: Active Comparator
description: Wound closure with non-absorbable suture.
intervention type: Procedure
intervention name: Wound closure
description: Comparison of two wound closures
arm group label: Absorbable suture
arm group label: Non-absorbable suture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Peter C Rhee
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
status: Recruiting
contact: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Peter C. Rhee
investigator title: Principal Investigator
mesh term: Trigger Finger Disorder
mesh term: Carpal Tunnel Syndrome
sharing ipd: No