<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/NCT04409093</url>
  </required_header>
  <id_info>
    <org_study_id>20-00355</org_study_id>
    <nct_id>NCT04409093</nct_id>
  </id_info>
  <brief_title>Eponychial Stent Study</brief_title>
  <official_title>A Prospective, Randomized, Controlled Trial Evaluating the Utility of Eponychial Stents for Nail Re-growth in Nail Bed Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>NYU Langone Health</source>
  <oversight_info>
    <has_dmc>Yes</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 study design is a prospective, randomized, controlled trial evaluating the cosmetic and&#xD;
      functional outcomes of nail bed repairs with and without eponychial stents. Patients&#xD;
      presenting to a single institution with a finger tip injury requiring a nail bed repair will&#xD;
      be initially evaluated in the emergency department. The purpose of the study will be&#xD;
      explained to the patient, and informed consent for participation will be obtained. Patients&#xD;
      will be randomly assigned to either the eponychial stent or no eponychial stent group based&#xD;
      on the last digit of their assigned medical record number. Even-numbered patients will be&#xD;
      randomized to the stent group and odd-numbered patients will be randomized to the no stent&#xD;
      group. Demographic data will be obtained and recorded (age, gender, hand dominance, mechanism&#xD;
      of injury, and past medical history). All patients will undergo a thorough clinical exam&#xD;
      under digital nerve block followed by removal of the nail plate and thorough irrigation and&#xD;
      debridement of devitalized tissue. The nail bed repair will be performed with 6-0 chromic&#xD;
      suture material. After the nail bed repair, a stent (native nail, suture container foil, or&#xD;
      nonadherent gauze) will or will not secured under the eponychial fold with suture depending&#xD;
      on randomization. Laceration characteristic and time required to perform the procedure will&#xD;
      be recorded. A nonadherent sterile dressing will be applied to the digit, and each patient&#xD;
      will be discharged with a 5-day course of cephalexin for prophylaxis against infection.&#xD;
      Follow-up evaluation will occur at 1 week, 1 month, 3 months, and 6 months. A each follow-up&#xD;
      visit, patient-perceived functional outcome, cosmetic outcome, and level of pain will be&#xD;
      assessed using a 10-point analog scale. Cosmetic results will also be evaluated by the&#xD;
      examining physician using a validated physician-based outcome tool.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">August 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient reported score on functional outcome scale (10-point analog scale)</measure>
    <time_frame>after procedure: 1 week, 1 month, 3 months, and 6 months</time_frame>
    <description>Mean score from all time points&#xD;
0 = complete loss of affected digit function during activities of daily living and recreational activities 10 = no functional limitation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient reported score on cosmetic outcome scale (10-point analog scale)</measure>
    <time_frame>after procedure: 1 week, 1 month, 3 months, and 6 months</time_frame>
    <description>Mean score from all time points&#xD;
0 = cosmetically unacceptable 10 = no perceived difference between treated finger and the same finger on the contralateral hand</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient reported pain level on Visual Analog Scale (VAS)</measure>
    <time_frame>after procedure: 1 week, 1 month, 3 months, and 6 months</time_frame>
    <description>Mean score from all time points&#xD;
0 = no pain 10 = persistent finger pain during rest and activity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Physician reported cosmetic outcome</measure>
    <time_frame>after procedure: 1 week, 1 month, 3 months, and 6 months</time_frame>
    <description>Mean score from all time points&#xD;
Zook et al. Excellent = identical in appearance to the same finger on the contralateral hand Very good = 1 variation from identical, such as incomplete adherence, nail ridging, split nails, or eponychial deformity.&#xD;
Good = 2 minor variations from identical. Poor = more than 3 variations or 1 major variation from the same finger on the contralateral hand.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedure time</measure>
    <time_frame>0-1 hour</time_frame>
    <description>To determine the added time taken to perform the eponychial stent following nail bed repair</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Eponychial Stent</condition>
  <condition>Nail Bed Injury</condition>
  <arm_group>
    <arm_group_label>Nail bed repair with eponychial sent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nail bed repair without eponychial stent</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nail bed repair with eponychial sent</intervention_name>
    <description>The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will be secured under the eponychial fold with suture. The stent can be the native nail plate, suture container foil, or nonadherent gauze (i.e. Xeroform). If the injury avulsed the nail plate and the patient presents without it, either the foil from the suture wrapper/container or a piece of nonadherent gauze (i.e. Xeroform) will be used as a stent. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection.</description>
    <arm_group_label>Nail bed repair with eponychial sent</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nail bed repair without eponychial stent</intervention_name>
    <description>The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will not be secured under the eponychial fold. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection.</description>
    <arm_group_label>Nail bed repair without eponychial stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Men and women, age &gt; 18 years.&#xD;
&#xD;
          2. Patients with either nail plate avulsion and/or fracture with associated nail bed&#xD;
             injury or subungal hematoma &gt; 50% with intact nail plate.&#xD;
&#xD;
          3. Presentation within 8 hours of injury.&#xD;
&#xD;
          4. Being treated at NYU Langone Health or Jamaica Hospital Medical Center.&#xD;
&#xD;
          5. Willingness to participate in the study&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        1. Nail plate/bed injury secondary to bite wound&#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>Nader Paksima, DO MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>NYU Langone Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ali Azad, MD</last_name>
    <phone>212-263-2192</phone>
    <email>ali.azad@nyulangone.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>NYU Langone Orthopedic Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ali Azad, MD</last_name>
    </contact>
    <investigator>
      <last_name>Nader Pakisma, DO, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tisch Hospital, NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ali Azad, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jamaica Hospital Medical Center</name>
      <address>
        <city>Richmond Hill</city>
        <state>New York</state>
        <zip>11418</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ali Azad, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>January 3, 2023</last_update_submitted>
  <last_update_submitted_qc>January 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.</ipd_time_frame>
    <ipd_access_criteria>Requests should be directed to ali.azad@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT04409093
org study id: 20-00355
nct id: NCT04409093
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study design is a prospective, randomized, controlled trial evaluating the cosmetic and
      functional outcomes of nail bed repairs with and without eponychial stents. Patients
      presenting to a single institution with a finger tip injury requiring a nail bed repair will
      be initially evaluated in the emergency department. The purpose of the study will be
      explained to the patient, and informed consent for participation will be obtained. Patients
      will be randomly assigned to either the eponychial stent or no eponychial stent group based
      on the last digit of their assigned medical record number. Even-numbered patients will be
      randomized to the stent group and odd-numbered patients will be randomized to the no stent
      group. Demographic data will be obtained and recorded (age, gender, hand dominance, mechanism
      of injury, and past medical history). All patients will undergo a thorough clinical exam
      under digital nerve block followed by removal of the nail plate and thorough irrigation and
      debridement of devitalized tissue. The nail bed repair will be performed with 6-0 chromic
      suture material. After the nail bed repair, a stent (native nail, suture container foil, or
      nonadherent gauze) will or will not secured under the eponychial fold with suture depending
      on randomization. Laceration characteristic and time required to perform the procedure will
      be recorded. A nonadherent sterile dressing will be applied to the digit, and each patient
      will be discharged with a 5-day course of cephalexin for prophylaxis against infection.
      Follow-up evaluation will occur at 1 week, 1 month, 3 months, and 6 months. A each follow-up
      visit, patient-perceived functional outcome, cosmetic outcome, and level of pain will be
      assessed using a 10-point analog scale. Cosmetic results will also be evaluated by the
      examining physician using a validated physician-based outcome tool.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Patient reported score on functional outcome scale (10-point analog scale)
time frame: after procedure: 1 week, 1 month, 3 months, and 6 months
description: Mean score from all time points
0 = complete loss of affected digit function during activities of daily living and recreational activities 10 = no functional limitation
measure: Patient reported score on cosmetic outcome scale (10-point analog scale)
time frame: after procedure: 1 week, 1 month, 3 months, and 6 months
description: Mean score from all time points
0 = cosmetically unacceptable 10 = no perceived difference between treated finger and the same finger on the contralateral hand
measure: Patient reported pain level on Visual Analog Scale (VAS)
time frame: after procedure: 1 week, 1 month, 3 months, and 6 months
description: Mean score from all time points
0 = no pain 10 = persistent finger pain during rest and activity
measure: Physician reported cosmetic outcome
time frame: after procedure: 1 week, 1 month, 3 months, and 6 months
description: Mean score from all time points
Zook et al. Excellent = identical in appearance to the same finger on the contralateral hand Very good = 1 variation from identical, such as incomplete adherence, nail ridging, split nails, or eponychial deformity.
Good = 2 minor variations from identical. Poor = more than 3 variations or 1 major variation from the same finger on the contralateral hand.
measure: Procedure time
time frame: 0-1 hour
description: To determine the added time taken to perform the eponychial stent following nail bed repair
arm group label: Nail bed repair with eponychial sent
arm group type: Experimental
arm group label: Nail bed repair without eponychial stent
arm group type: Active Comparator
intervention type: Procedure
intervention name: Nail bed repair with eponychial sent
description: The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will be secured under the eponychial fold with suture. The stent can be the native nail plate, suture container foil, or nonadherent gauze (i.e. Xeroform). If the injury avulsed the nail plate and the patient presents without it, either the foil from the suture wrapper/container or a piece of nonadherent gauze (i.e. Xeroform) will be used as a stent. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection.
arm group label: Nail bed repair with eponychial sent
intervention type: Procedure
intervention name: Nail bed repair without eponychial stent
description: The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will not be secured under the eponychial fold. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection.
arm group label: Nail bed repair without eponychial stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nader Paksima, DO MPH
role: Principal Investigator
affiliation: NYU Langone Health
last name: Ali Azad, MD
phone: 212-263-2192
email: ali.azad@nyulangone.org
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: United States
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [contact information for PI or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
ipd access criteria: Requests should be directed to ali.azad@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.