<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/NCT01707654</url>
  </required_header>
  <id_info>
    <org_study_id>TSChen6017</org_study_id>
    <secondary_id>HEBEI-J06451</secondary_id>
    <nct_id>NCT01707654</nct_id>
  </id_info>
  <brief_title>Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap</brief_title>
  <official_title>Repair of Infective Wound Associated With Nerve Defect in the Finger Using A Bipedicled Nerve Flap</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Hospital of Tangshan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Hospital of Tangshan</source>
  <brief_summary>
    <textblock>
      A combination of soft tissue and digital nerve defects in the finger results in sensory loss&#xD;
      of the finger pulp. Reconstruction of these combined injuries is difficult. When the&#xD;
      neurocutaneous defect is associated with wound infection, reconstructive alternatives are&#xD;
      more limited. From July 2008 to May 2010, a retrospective study was conducted with 9&#xD;
      consecutive postinfection patients who had the neurocutaneous defect of the finger following&#xD;
      trauma. The purpose of this retrospective study is to report repair of the complicated&#xD;
      infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of&#xD;
      this technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      sensation of the flaps is assessed using static two-point discrimination (2PD) and&#xD;
      Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the&#xD;
      injured finger is measured using the self-administered Cold Intolerance Severity Score&#xD;
      questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and&#xD;
      76-100). Patients report their satisfaction with functional recovery of the injured finger&#xD;
      according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response&#xD;
      scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2008</start_date>
  <completion_date type="Actual">February 2012</completion_date>
  <primary_completion_date type="Actual">May 2010</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>2-point Discrimination Test</measure>
    <time_frame>17-25 months</time_frame>
    <description>The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent &lt;6 mm; good 6-10 mm; fair 11-15 mm; poor &gt;15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Semmes-Weinstein (SW) Monofilament Test</measure>
    <time_frame>17-25 months</time_frame>
    <description>The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain</measure>
    <time_frame>17-25 months</time_frame>
    <description>Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1-3 cm), moderate (4-6 cm) and severe (7-10 cm).</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Infection Wound</condition>
  <condition>Disruption of Nerve Repair</condition>
  <arm_group>
    <arm_group_label>nerve graft</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nerve flap</intervention_name>
    <description>Based on the Teoh et al.'s technique, we combined the nerve graft into the bipedicled heterodigital arterialized island flap and used this composite flap tissue for reconstructing complicated infected wound in the finger.</description>
    <arm_group_label>nerve graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  an infective wound with exposed bone or tendon in the finger;&#xD;
&#xD;
          -  soft tissue defect involving proximal half of the middle phalanx, the proximal&#xD;
             phalanx, or both;&#xD;
&#xD;
          -  associated digital nerve defect 1 to 4 cm in length;&#xD;
&#xD;
          -  single or double nerve defects; and&#xD;
&#xD;
          -  simultaneous repair of nerve and soft tissue defects.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  injury to the course of the pedicle or the donor site;&#xD;
&#xD;
          -  nerve defect less than 1 cm or larger than 4 cm in length;&#xD;
&#xD;
          -  occurrence of the defect in a region the flap is unable to reach, such as distal&#xD;
             interphalangeal joint region, distal portion of the middle phalanx of the middle&#xD;
             finger and the thumb;&#xD;
&#xD;
          -  no involvement of the digital nerve.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Second Hospital of Tangshan</name>
      <address>
        <city>Tangshan</city>
        <state>Hebei</state>
        <zip>063000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Chen C, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011.</citation>
    <PMID>20888502</PMID>
  </results_reference>
  <verification_date>April 2012</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <results_first_submitted>June 3, 2013</results_first_submitted>
  <results_first_submitted_qc>August 18, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 23, 2013</results_first_posted>
  <last_update_submitted>October 25, 2018</last_update_submitted>
  <last_update_submitted_qc>October 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>defect;</keyword>
  <keyword>dorsal branch of the proper digital nerve;</keyword>
  <keyword>proper digital nerve;</keyword>
  <keyword>finger sensory reconstruction.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>From July 2008 to May 2010, 9 patients who had a combination of soft tissue and digital nerve defects were included in the study. The type of location was medical clinic.</recruitment_details>
      <pre_assignment_details>No patient was lost to follow-up</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nerve Graft</title>
          <description>Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nerve Graft</title>
          <description>Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.6" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>China</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>2-point Discrimination Test</title>
        <description>The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent &lt;6 mm; good 6-10 mm; fair 11-15 mm; poor &gt;15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.</description>
        <time_frame>17-25 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nerve Graft</title>
            <description>Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.</description>
          </group>
        </group_list>
        <measure>
          <title>2-point Discrimination Test</title>
          <description>The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent &lt;6 mm; good 6-10 mm; fair 11-15 mm; poor &gt;15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Semmes-Weinstein (SW) Monofilament Test</title>
        <description>The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.</description>
        <time_frame>17-25 months</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Pain</title>
        <description>Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1-3 cm), moderate (4-6 cm) and severe (7-10 cm).</description>
        <time_frame>17-25 months</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>One year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Nerve Graft</title>
          <description>Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="9"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Chao Chen</name_or_title>
      <organization>The Second Hospital of Tangshan</organization>
      <phone>86-13700350471</phone>
      <email>ts_chenchao@163.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01707654
org study id: TSChen6017
secondary id: HEBEI-J06451
nct id: NCT01707654
lead sponsor: 
A combination of soft tissue and digital nerve defects in the finger results in sensory loss
      of the finger pulp. Reconstruction of these combined injuries is difficult. When the
      neurocutaneous defect is associated with wound infection, reconstructive alternatives are
      more limited. From July 2008 to May 2010, a retrospective study was conducted with 9
      consecutive postinfection patients who had the neurocutaneous defect of the finger following
      trauma. The purpose of this retrospective study is to report repair of the complicated
      infected wound in the finger using the bipedicled nerve flap and to evaluate the efficacy of
      this technique.
sensation of the flaps is assessed using static two-point discrimination (2PD) and
      Semmes-Weinstein monofilament (SWM) testing at final follow-up. The cold intolerance of the
      injured finger is measured using the self-administered Cold Intolerance Severity Score
      questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and
      76-100). Patients report their satisfaction with functional recovery of the injured finger
      according to the Michigan Hand Outcomes Questionnaire that was based on a 5-point response
      scale.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 2-point Discrimination Test
time frame: 17-25 months
description: The 2-point Discrimination Test determines the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines were used to stratify Discriminator measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm. The test points were at the center of the radial or ulnar portion of the pulp. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4 mm as a limit of 2PD and considered this normal. The assessments were performed at a single time point at the final follow up.
measure: Semmes-Weinstein (SW) Monofilament Test
time frame: 17-25 months
description: The test points were at the center of the radial or ulnar portion of the pulp. The donor site, i.e. radial- or ulnar-dorsal aspect of the middle phalanx of the donor digit, was also evaluated.
measure: Pain
time frame: 17-25 months
description: Pain was given subjectively by the patient using the visual analogue scale (VAS). The VAS consists of a 10 cm line that was grouped into mild (1-3 cm), moderate (4-6 cm) and severe (7-10 cm).
arm group label: nerve graft
arm group type: Other
description: Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
intervention type: Device
intervention name: Nerve flap
description: Based on the Teoh et al.'s technique, we combined the nerve graft into the bipedicled heterodigital arterialized island flap and used this composite flap tissue for reconstructing complicated infected wound in the finger.
arm group label: nerve graft
criteria: 
gender: All
minimum age: 16 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
citation: Chen C, Zhang X, Shao X, Gao S, Wang B, Liu D. Treatment of a combination of volar soft tissue and proper digital nerve defects using the dorsal digital nerve island flap. J Hand Surg Am. 2010 Oct;35(10):1655-1662.e3. doi: 10.1016/j.jhsa.2010.07.011.
PMID: 20888502
responsible party type: Sponsor
mesh term: Wounds and Injuries
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 