<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/NCT04455490</url>
  </required_header>
  <id_info>
    <org_study_id>M2019492</org_study_id>
    <nct_id>NCT04455490</nct_id>
  </id_info>
  <brief_title>Clinical Effect of Endoscopic Surgery for Delayed Wound Healing After Achilles Tendon Suture</brief_title>
  <official_title>Clinical Effect of Endoscopic Surgery for Delayed Wound Healing After Achilles Tendon Suture</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</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>
      This study proposes endoscopic surgery for delayed wound healing after Achilles tendon suture&#xD;
      which is a brand new treatment，and retrospectively analyzed the clinical data of 4 cases&#xD;
      treated with this treatment. The analysis results of the clinical efficacy of the method can&#xD;
      serve as a reference for clinical and surgical decision-making and prognosis assessment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Delayed wound healing is a kind of postoperative complication of Achilles tendon&#xD;
      suture. Conventional surgical approach is open surgery in order to clean the wound, which&#xD;
      requires multiple dressing changes and involves a longer recovery period. We recently&#xD;
      developed arthroscopic surgery for delayed wound healing after Achilles tendon suture. This&#xD;
      therapy may be an alternative approach to open surgery.&#xD;
&#xD;
      Purposes: In this paper we evaluate the long-term efficacy of endoscopic surgery for delayed&#xD;
      wound healing after Achilles tendon suture.&#xD;
&#xD;
      Patients and Methods: Clinical data of 4 patients with delayed wound healing after Achilles&#xD;
      tendon suture who underwent endoscopic surgery from April 2008 to October 2017 at our&#xD;
      institute were retrospectively analyzed. There were 3 males and 1 females with age of 39-60&#xD;
      years, the follow-up period was 8-43 months). All the patients had unilateral tendon rupture&#xD;
      with 3 cases on the left and 1 cases on the right. Scores on Visual analogue scale(VAS) and&#xD;
      the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale were used. The&#xD;
      postoperative outcome was evaluated on the basis of Victorian Institute of Sport&#xD;
      Assessment-Achilles score and Achilles tendon total rupture score (ATRS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2020</start_date>
  <completion_date type="Actual">May 18, 2020</completion_date>
  <primary_completion_date type="Actual">April 18, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale</measure>
    <time_frame>8 months to 4 years after the surgery</time_frame>
    <description>Use Visual Analog Scale(VAS) to evaluate the pain recovery of patients who received endoscopic surgery. VAS ranges from 0 to 10, higher scores mean a worse outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score</measure>
    <time_frame>8 months to 4 years after the surgery</time_frame>
    <description>Use American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score(AOFAS) to evaluate the function recovery of patients who received endoscopic surgery. AOFAS ranges from 0 to 100, higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Victorian Institute of Sport Assessment-Achilles</measure>
    <time_frame>8 months to 4 years after the surgery</time_frame>
    <description>Use Victorian Institute of Sport Assessment-Achilles(VISA-A) to evaluate the pain and movement recovery of patients who received endoscopic surgery. VISA-A ranges from 0 to 100, higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Achilles tendon total rupture score</measure>
    <time_frame>8 months to 4 years after the surgery</time_frame>
    <description>Use Achilles tendon total rupture score(ATRS) to evaluate the function and movement recovery of patients who received endoscopic surgery. VISA-A ranges from 0 to 100, higher scores mean a better outcome.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tegner knee motion score</measure>
    <time_frame>8 months to 4 years after the surgery</time_frame>
    <description>Use Tegner knee motion score to evaluate the sports ability of patients who received endoscopic surgery. Tegner knee motion score ranges from 0 to 10, higher scores mean a better outcome.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">4</enrollment>
  <condition>Wound Healing</condition>
  <arm_group>
    <arm_group_label>Delayed wound healing</arm_group_label>
    <description>Patients with delayed wound healing after Achilles tendon suture who were treated at Peking University Third Hospital</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-control</intervention_name>
    <description>We compared relevant scores of patients before and after surgery</description>
    <arm_group_label>Delayed wound healing</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        4 patients with delayed healing after Achilles tendon suture surgery who were treated at&#xD;
        our institution, in the period from April 2008 to July 2019. The patients were 3 men and 1&#xD;
        woman, aged 39 to 60 years. Among them, 3 had surgery on the left Achilles tendon and 1 had&#xD;
        surgery on the right Achilles tendon. The time from the first operation (Achilles tendon&#xD;
        suture) to foreign body reaction ranged from 1 month to 5 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The diagnostic criteria for delayed wound healing after Achilles tendon suture are&#xD;
             met, namely the presence of skin necrosis, wound nonunion, or delayed wound healing.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The expected healing time of wounds with regular dressing changes is &lt;2 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Achilles tendon suture</keyword>
  <keyword>Delayed wound healing</keyword>
  <keyword>Endoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT04455490
org study id: M2019492
nct id: NCT04455490
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study proposes endoscopic surgery for delayed wound healing after Achilles tendon suture
      which is a brand new treatment，and retrospectively analyzed the clinical data of 4 cases
      treated with this treatment. The analysis results of the clinical efficacy of the method can
      serve as a reference for clinical and surgical decision-making and prognosis assessment.
Background: Delayed wound healing is a kind of postoperative complication of Achilles tendon
      suture. Conventional surgical approach is open surgery in order to clean the wound, which
      requires multiple dressing changes and involves a longer recovery period. We recently
      developed arthroscopic surgery for delayed wound healing after Achilles tendon suture. This
      therapy may be an alternative approach to open surgery.

      Purposes: In this paper we evaluate the long-term efficacy of endoscopic surgery for delayed
      wound healing after Achilles tendon suture.

      Patients and Methods: Clinical data of 4 patients with delayed wound healing after Achilles
      tendon suture who underwent endoscopic surgery from April 2008 to October 2017 at our
      institute were retrospectively analyzed. There were 3 males and 1 females with age of 39-60
      years, the follow-up period was 8-43 months). All the patients had unilateral tendon rupture
      with 3 cases on the left and 1 cases on the right. Scores on Visual analogue scale(VAS) and
      the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale were used. The
      postoperative outcome was evaluated on the basis of Victorian Institute of Sport
      Assessment-Achilles score and Achilles tendon total rupture score (ATRS).
observational model: Case-Only
time perspective: Retrospective
measure: Visual Analogue Scale
time frame: 8 months to 4 years after the surgery
description: Use Visual Analog Scale(VAS) to evaluate the pain recovery of patients who received endoscopic surgery. VAS ranges from 0 to 10, higher scores mean a worse outcome.
measure: American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
time frame: 8 months to 4 years after the surgery
description: Use American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score(AOFAS) to evaluate the function recovery of patients who received endoscopic surgery. AOFAS ranges from 0 to 100, higher scores mean a better outcome.
measure: Victorian Institute of Sport Assessment-Achilles
time frame: 8 months to 4 years after the surgery
description: Use Victorian Institute of Sport Assessment-Achilles(VISA-A) to evaluate the pain and movement recovery of patients who received endoscopic surgery. VISA-A ranges from 0 to 100, higher scores mean a better outcome.
measure: Achilles tendon total rupture score
time frame: 8 months to 4 years after the surgery
description: Use Achilles tendon total rupture score(ATRS) to evaluate the function and movement recovery of patients who received endoscopic surgery. VISA-A ranges from 0 to 100, higher scores mean a better outcome.
measure: Tegner knee motion score
time frame: 8 months to 4 years after the surgery
description: Use Tegner knee motion score to evaluate the sports ability of patients who received endoscopic surgery. Tegner knee motion score ranges from 0 to 10, higher scores mean a better outcome.
arm group label: Delayed wound healing
description: Patients with delayed wound healing after Achilles tendon suture who were treated at Peking University Third Hospital
intervention type: Other
intervention name: Self-control
description: We compared relevant scores of patients before and after surgery
arm group label: Delayed wound healing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No