xml: <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/NCT05997186</url>
    </required_header>
    <id_info>
      <org_study_id>2023-00938; mu23schaefer</org_study_id>
      <nct_id>NCT05997186</nct_id>
    </id_info>
    <brief_title>Reinnervated PAP Flap for Oral Cavity and Oropharyngeal Defect Reconstruction</brief_title>
    <official_title>Sensory Recovery and Functional Outcome After Reinnervated Profunda Artery Perforator Flap for Oral Cavity and Oropharyngeal Defect Reconstruction - Prospective Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Basel, Switzerland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Hospital, Basel, Switzerland</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>
        The aim of this study is to investigate sensory recovery and functional outcomes following&#xD;
        oral cavity and oropharyngeal defect reconstruction with reinnervated PAP (profunda artery&#xD;
        perforator) flaps.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Tumor resections involving the oral cavity or oropharynx cause significant functional&#xD;
        deficits in swallowing and speech and subsequently impair the patients' quality of life. The&#xD;
        anterolateral thigh (ALT) flap is widely regarded as a workhorse flap to reconstruct such&#xD;
        defects. Previous studies assessing recovery of reinnervated ALT flaps reported superior&#xD;
        sensory recovery, improved swallow function, and improved overall patient satisfaction in&#xD;
        patients with reinnervated flaps compared with patients who received ALT flap reconstruction&#xD;
        without sensory reinnervation. Recently, the profunda artery perforator (PAP) flap has been&#xD;
        proposed as an alternative donor site in malnourished patients with thin lateral thigh&#xD;
        thickness. However, reinnervation of PAP flaps has not been described. The study assesses&#xD;
        sensory recovery after defect reconstruction with the reinnervated profunda artery perforator&#xD;
        flap using already approved, non-invasive testing (Semmes-Weinstein monofilament testing,&#xD;
        two-point discrimination, temperature, pain perception)&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2027</completion_date>
    <primary_completion_date type="Anticipated">May 2027</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>
      <intervention_model_description>Prospective case series (pilot study)</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Semmes-Weinstein monofilament testing</measure>
      <time_frame>before surgery and 3, 6 and 12 month after surgery</time_frame>
      <description>The Semmes-Weinstein Monofilament test is a sensory assessment tool. This assessment tool consists of a set of monofilaments that vary in thickness and diameter, the gradient forces of these monofilaments ranges from .086 gm to 448gm. These monofilaments are used to map out sensory loss or recovery.&#xD;
  Semmes-Weinstein monofilament testing will be performed at the tip (distal 1 cm) and the dorsum of the reconstructed flap/neo-tongue. Semmes-Weinstein monofilament testing will also be performed in the profunda artery perforator flap territory on the ipsilateral and contralateral thigh. For this purpose, the investigators will use the &quot;Baseline FoldUp Monofilament Evaluator Set with Case&quot;.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in two-point discrimination test</measure>
      <time_frame>before surgery and 3, 6 and 12 month after surgery</time_frame>
      <description>The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It will be measured using &quot;Dellon Disk Criminator&quot;</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in temperature perception</measure>
      <time_frame>before surgery and 3, 6 and 12 month after surgery</time_frame>
      <description>Hot (50 degrees Celsius) and cold (4 degrees Celsius) temperature perception will be assessed by use of a small test tube filled with water at the appropriate temperatures.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in pain perception</measure>
      <time_frame>before surgery and 3, 6 and 12 month after surgery</time_frame>
      <description>Pain perception will be assessed with a 27-gauge needle.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Oral Cavity Defect</condition>
    <condition>Oropharynx Defect</condition>
    <arm_group>
      <arm_group_label>Surgery</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Oral cavity and oropharyngeal defect reconstruction</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Surgical reconstruction</intervention_name>
      <description>Surgical reconstruction with a free reinnervated profunda artery perforator flap</description>
      <arm_group_label>Surgery</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - Patient with defect involving the oral cavity or oropharynx who undergo reconstruction&#xD;
          with a free reinnervated profunda artery perforator flap&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;18 years old&#xD;
  &#xD;
            -  Defect localizations other than the oral cavity or oropharynx&#xD;
  &#xD;
            -  Not able to give informed consent&#xD;
  &#xD;
            -  Inability to follow the procedures of the study, e.g., due to psychological disorders,&#xD;
               dementia&#xD;
  &#xD;
            -  Inability or contraindications to undergo the investigated intervention&#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>Nicole E. Speck, Dr. med.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital, Basel, Switzerland</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nicole E. Speck, Dr. med.</last_name>
      <phone>+41 61 328 41 64</phone>
      <email>nicoleedith.speck@usb.ch</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dirk J. Schaefer, Prof. Dr.</last_name>
      <email>dirk.schaefer@usb.ch</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University Hospital Basel</name>
        <address>
          <city>Basel</city>
          <zip>4031</zip>
          <country>Switzerland</country>
        </address>
      </facility>
      <contact>
        <last_name>Nicole E. Speck, Dr. med.</last_name>
        <email>nicoleedith.speck@usb.ch</email>
      </contact>
      <contact_backup>
        <last_name>Dirk J Schaefer, Prof. Dr.</last_name>
        <email>dirk.schaefer@usb.ch</email>
      </contact_backup>
      <investigator>
        <last_name>Nicole E. Speck, Dr. med.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tarek Ismail, PD Dr. med.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Dirk J. Schaefer, Prof. Dr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Laurent Muller, PD Dr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Britta Gahl, PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>reconstruction with a free reinnervated profunda artery perforator flap</keyword>
    <keyword>sensory recovery</keyword>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997186
  org study id: 2023-00938; mu23schaefer
  nct id: NCT05997186
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to investigate sensory recovery and functional outcomes following
        oral cavity and oropharyngeal defect reconstruction with reinnervated PAP (profunda artery
        perforator) flaps.
  Tumor resections involving the oral cavity or oropharynx cause significant functional
        deficits in swallowing and speech and subsequently impair the patients' quality of life. The
        anterolateral thigh (ALT) flap is widely regarded as a workhorse flap to reconstruct such
        defects. Previous studies assessing recovery of reinnervated ALT flaps reported superior
        sensory recovery, improved swallow function, and improved overall patient satisfaction in
        patients with reinnervated flaps compared with patients who received ALT flap reconstruction
        without sensory reinnervation. Recently, the profunda artery perforator (PAP) flap has been
        proposed as an alternative donor site in malnourished patients with thin lateral thigh
        thickness. However, reinnervation of PAP flaps has not been described. The study assesses
        sensory recovery after defect reconstruction with the reinnervated profunda artery perforator
        flap using already approved, non-invasive testing (Semmes-Weinstein monofilament testing,
        two-point discrimination, temperature, pain perception)
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Prospective case series (pilot study)
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in Semmes-Weinstein monofilament testing
  time frame: before surgery and 3, 6 and 12 month after surgery
  description: The Semmes-Weinstein Monofilament test is a sensory assessment tool. This assessment tool consists of a set of monofilaments that vary in thickness and diameter, the gradient forces of these monofilaments ranges from .086 gm to 448gm. These monofilaments are used to map out sensory loss or recovery.
  Semmes-Weinstein monofilament testing will be performed at the tip (distal 1 cm) and the dorsum of the reconstructed flap/neo-tongue. Semmes-Weinstein monofilament testing will also be performed in the profunda artery perforator flap territory on the ipsilateral and contralateral thigh. For this purpose, the investigators will use the "Baseline FoldUp Monofilament Evaluator Set with Case".
  measure: Change in two-point discrimination test
  time frame: before surgery and 3, 6 and 12 month after surgery
  description: The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It will be measured using "Dellon Disk Criminator"
  measure: Change in temperature perception
  time frame: before surgery and 3, 6 and 12 month after surgery
  description: Hot (50 degrees Celsius) and cold (4 degrees Celsius) temperature perception will be assessed by use of a small test tube filled with water at the appropriate temperatures.
  measure: Change in pain perception
  time frame: before surgery and 3, 6 and 12 month after surgery
  description: Pain perception will be assessed with a 27-gauge needle.
  arm group label: Surgery
  arm group type: Other
  description: Oral cavity and oropharyngeal defect reconstruction
  intervention type: Procedure
  intervention name: Surgical reconstruction
  description: Surgical reconstruction with a free reinnervated profunda artery perforator flap
  arm group label: Surgery
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Nicole E. Speck, Dr. med.
  role: Principal Investigator
  affiliation: University Hospital, Basel, Switzerland
  last name: Nicole E. Speck, Dr. med.
  phone: +41 61 328 41 64
  email: nicoleedith.speck@usb.ch
  last name: Dirk J. Schaefer, Prof. Dr.
  email: dirk.schaefer@usb.ch
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Switzerland
  responsible party type: Sponsor