<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/NCT03013608</url>
  </required_header>
  <id_info>
    <org_study_id>6529</org_study_id>
    <nct_id>NCT03013608</nct_id>
  </id_info>
  <brief_title>Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate</brief_title>
  <acronym>Ongl'HUS</acronym>
  <official_title>Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Strasbourg, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Strasbourg, France</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>
      Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries.&#xD;
      The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The&#xD;
      empirical reparation technique is the nail bed suture and the relocation of the nail plate.&#xD;
      However, some authors think that suture the nail bed could increase the traumatism of the&#xD;
      nail bed because of the needle, the crush by the clamps and by the stitches too tight&#xD;
      (Langlois, Yam). An author has proposed, in a prospective, randomized clinical trial to treat&#xD;
      the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the nail bed.&#xD;
      Advantages of this technique, claimed by the author, was time saving, with an aesthetical&#xD;
      result as same as the treatment with suture of the nail bed. A same study validated the&#xD;
      technique in a paediatric population (Langlois et al., 2010). So, it seems that it is not&#xD;
      necessary to suture the nail bed. But, in our practice, the investigators noted complications&#xD;
      not mentioned in previous studies: hematomas causing pain, effusion and dislocation of the&#xD;
      nail plate, with constrain the patient to consult in emergency. The 2-octylcyanoacrylate is&#xD;
      difficult to use in nail bed injuries and is expensive. Our hypothesis is the simple&#xD;
      relocation of the nail plate in nail bed injuries in paediatric population is enough to have&#xD;
      good to excellent aesthetical results, with less complications and a lower cost, than the&#xD;
      other techniques. The aim of this study is to assess the aesthetical results 3 months after&#xD;
      simple relocation of the nail plate for nail bed injuries in children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    recruitment difficulty&#xD;
  </why_stopped>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Actual">June 19, 2020</completion_date>
  <primary_completion_date type="Actual">June 19, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Nail aesthetical results</measure>
    <time_frame>The evaluation is assessed at 6 months after the treatmen6</time_frame>
    <description>Evaluation with the Zook's scale at 6 months postoperative based on photographs of the injured finger compared with the finger on the opposite side. The evaluation will be done by five persons (surgeons, nurses, therapists….)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications rate at short term (before 15 days): haematoma, infection, dislocation of the nail plate,: hook nail</measure>
    <time_frame>at 15 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The pain with an analogic scale for children over 7 years-old,</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction rate at 6 months, compared with the contralateral finger, by the children (if possible) and by parents, on a scale to 0 (not satisfied) to 10 (very satisfied).</measure>
    <time_frame>at 6 months</time_frame>
    <description>photographs, evaluation of the roughness by the surgeon, the nurse and parents, satisfaction of the aspect of the nail on a scale (0 to 10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications rate: haematoma, infection, dislocation of the nail plate,at medium term (between 15 days and 3 months): hook nail</measure>
    <time_frame>at 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Nail Bed Injury</condition>
  <arm_group>
    <arm_group_label>relocation of nail plate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the simple relocation of the nail plate in nailbed injuries in paediatric population</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Simple relocation of the nail plate in nailbed injuries in paediatric population</intervention_name>
    <description>Repositioning the nail bed without sutures</description>
    <arm_group_label>relocation of nail plate</arm_group_label>
    <other_name>Reparation of the nail bed injuries</other_name>
    <other_name>Repositioning the nail bed without sutures</other_name>
    <other_name>Relocation of the nail</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age under 18 yo&#xD;
&#xD;
          -  nail bed injuries and/or nail matrix&#xD;
&#xD;
          -  nail plate &gt; 30% of the surface comparing the opposite side&#xD;
&#xD;
          -  one or more digits&#xD;
&#xD;
          -  signature of the 2 parents&#xD;
&#xD;
          -  social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  loss of more than 30% of the surface of the nail bed&#xD;
&#xD;
          -  Multiples lesions: nerve injury, tendon, fracture or luxation without indication of&#xD;
             osteosynthesis, loss of skin with indication of a flap&#xD;
&#xD;
          -  osteosynthesis of the distal phalanx&#xD;
&#xD;
          -  injuries by bite&#xD;
&#xD;
          -  previous pathology of the nail&#xD;
&#xD;
          -  contraindication of Lidocaine, bicarbonate de sodium, Kalinox, Biseptine, Vicryl&#xD;
             rapide, Adaptic&#xD;
&#xD;
          -  no information possible&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  breastfeeding&#xD;
&#xD;
          -  other inclusion in another study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Strasbourg,</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>July 24, 2020</last_update_submitted>
  <last_update_submitted_qc>July 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nail bed injury</keyword>
  <keyword>Nail bed injuries</keyword>
  <keyword>Nail</keyword>
  <keyword>Children</keyword>
  <keyword>Fingertip injury</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT03013608
org study id: 6529
nct id: NCT03013608
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries.
      The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The
      empirical reparation technique is the nail bed suture and the relocation of the nail plate.
      However, some authors think that suture the nail bed could increase the traumatism of the
      nail bed because of the needle, the crush by the clamps and by the stitches too tight
      (Langlois, Yam). An author has proposed, in a prospective, randomized clinical trial to treat
      the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the nail bed.
      Advantages of this technique, claimed by the author, was time saving, with an aesthetical
      result as same as the treatment with suture of the nail bed. A same study validated the
      technique in a paediatric population (Langlois et al., 2010). So, it seems that it is not
      necessary to suture the nail bed. But, in our practice, the investigators noted complications
      not mentioned in previous studies: hematomas causing pain, effusion and dislocation of the
      nail plate, with constrain the patient to consult in emergency. The 2-octylcyanoacrylate is
      difficult to use in nail bed injuries and is expensive. Our hypothesis is the simple
      relocation of the nail plate in nail bed injuries in paediatric population is enough to have
      good to excellent aesthetical results, with less complications and a lower cost, than the
      other techniques. The aim of this study is to assess the aesthetical results 3 months after
      simple relocation of the nail plate for nail bed injuries in children.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Nail aesthetical results
time frame: The evaluation is assessed at 6 months after the treatmen6
description: Evaluation with the Zook's scale at 6 months postoperative based on photographs of the injured finger compared with the finger on the opposite side. The evaluation will be done by five persons (surgeons, nurses, therapists….)
measure: Complications rate at short term (before 15 days): haematoma, infection, dislocation of the nail plate,: hook nail
time frame: at 15 days
measure: The pain with an analogic scale for children over 7 years-old,
time frame: at 6 months
measure: Satisfaction rate at 6 months, compared with the contralateral finger, by the children (if possible) and by parents, on a scale to 0 (not satisfied) to 10 (very satisfied).
time frame: at 6 months
description: photographs, evaluation of the roughness by the surgeon, the nurse and parents, satisfaction of the aspect of the nail on a scale (0 to 10)
measure: Complications rate: haematoma, infection, dislocation of the nail plate,at medium term (between 15 days and 3 months): hook nail
time frame: at 6 months
arm group label: relocation of nail plate
arm group type: Experimental
description: the simple relocation of the nail plate in nailbed injuries in paediatric population
intervention type: Procedure
intervention name: Simple relocation of the nail plate in nailbed injuries in paediatric population
description: Repositioning the nail bed without sutures
arm group label: relocation of nail plate
other name: Reparation of the nail bed injuries
other name: Repositioning the nail bed without sutures
other name: Relocation of the nail
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Wounds and Injuries