<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/NCT03793374</url>
  </required_header>
  <id_info>
    <org_study_id>201801926B0</org_study_id>
    <nct_id>NCT03793374</nct_id>
  </id_info>
  <brief_title>Modified Suction-assisted Cartilage Shaver for Axillary Osmidrosis</brief_title>
  <official_title>The Efficacy of Modified Suction-assisted Cartilage Shaver for Axillary Osmidrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <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 included patients who suffered from moderate to severe axillary osmidrosis to&#xD;
      receive the modified suction-assisted cartilage shaver, and evaluated the efficacy and&#xD;
      complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &lt;Patients&gt; After obtaining the agreement of Chang Gung Medical Foundation Institutional&#xD;
      Review Board, the investigators retrospectively included patients from July 2013 to September&#xD;
      2017. There were 39 patients treated for AO by the same dermatologist with suction-assisted&#xD;
      cartilage shaver at the Department of Dermatology, Chang Gung Memorial Hospital, Kaohsiung,&#xD;
      Taiwan. There were 28 females and 11 males, ranging from 14 to 52 years of age. The&#xD;
      participants were all bothered by the axillary osmidrosis, which had a huge impact on their&#xD;
      daily life with the embarrassing malodors. Operations were performed under local anaesthesia&#xD;
      and in an outpatient basis.&#xD;
&#xD;
      &lt;Operation&gt; During the procedure, both of patient's axillae were exposed with the patient&#xD;
      lying supine and arms abducted to avoid injury to the brachial plexus. The investigator cut&#xD;
      the axillary hair short for better visualizing the region of apocrine glands, which are&#xD;
      located near the hair follicles. The hair bearing elliptical region of axilla was marked&#xD;
      before hair cutting. Tumescent solution was prepared with 0.1% lidocaine, 1:500,000&#xD;
      epinephrine and 10mEq/L sodium bicarbonate. The investigator injected the tumescent solution&#xD;
      to the subcutaneous level of each axilla in view of the hydro-dissection ability of tumescent&#xD;
      and minimizing the bleeding.&#xD;
&#xD;
      A 0.5-cm long incision was made in the center of identified elliptical surgical area at each&#xD;
      axilla for the better access of arthroscopy to remove the apocrine glands located at&#xD;
      dermo-subcutaneous junction, and for hiding the scar in the skin crease to make it less&#xD;
      noticeable. A suction-assisted cartilage shaver (E9005 System, Linvatec Corporation, Largo,&#xD;
      Florida, USA) was introduced through the incisions to remove of the subcutaneous tissue&#xD;
      containing the apocrine glands radially. The investigator set the system to keep the inner&#xD;
      cannula at 1500 rotations per minute in oscillation mode. After defatting, the incisions were&#xD;
      closed primarily with 4-0 polyglactin. The investigator anchored the defatting skin to the&#xD;
      axillary fascia by using 4-0 nylon sutures instead of the tie-over dressing used in the&#xD;
      conventional shaver procedure, and the investigator also made several drainage holes by&#xD;
      inserting an 18G needle obliquely into the defatting skin rather than placing the drainage&#xD;
      tubes used in the conventional shaver procedure. Therefore, draining tubes were no longer&#xD;
      needed. The investigator will remove the stitches at the 8th day after the operation.&#xD;
&#xD;
      &lt;Efficacy assessments&gt; The participants' medical history, physical examinations, and vital&#xD;
      signs were carefully collected before the operation. The investigators retrospectively&#xD;
      evaluated the pre- and post-operative clinical efficacies with a patient-centered scoring&#xD;
      method. The severity of AO before the operation was classified from 1 to 5 to indicate the&#xD;
      least severe to the most severe condition, from undetectable, mild, moderate, severe, to&#xD;
      unbearable of malodor. The clinical efficacy was classified to 5 grades: poor (0%-20%), fair&#xD;
      (21%-39%), acceptable (40%- 59%), good(60%-79%), and excellent (80%-100%), which was&#xD;
      evaluated based on the elimination of malodor and the post-operative satisfaction. To&#xD;
      evaluate the safety, adverse reactions such as hematoma, seroma, infection, wound necrosis,&#xD;
      skin necrosis or perforation, and scar formation were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 12, 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>The change of malodor of axillary osmidorsis after the modified suction-assiated cartilage shaver</measure>
    <time_frame>The treatment efficacy is evaluated 1 year after the surgery.</time_frame>
    <description>The efficacy of surgical treatment for axillary osmidrosis is evaluated by the change of the malodor. The degree of malodor is subjective, therefore, the investigators classified the degree of malodor from 1 to 5 to indicate the least severe to the most sever condition. The degree of malodor was recorded before the operation, 1 month after the operation, and 1 year after the operation. The investigators evaluate the efficacy of the surgical treatment by the changes of the degree of the malodor of axillary osmidrosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The rate of complications of the modified suction-assiated cartilage shaver for axillary osmidrosis</measure>
    <time_frame>The immediate and longterm complications are recorded and evaluated at 1 week and 1 year respectively after the surgery.</time_frame>
    <description>To evaluate the safety of the modified surgical method, adverse reactions such as hematoma, seroma, infection, wound necrosis, skin necrosis or perforation, and scar formation were recorded and evaluated.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Treatment Outcome</condition>
  <condition>Axillary Odor, Variation in</condition>
  <arm_group>
    <arm_group_label>Axillary osmidrosis patients</arm_group_label>
    <description>Patients with axillary malodor and require surgical intervention. The subcutaneous apocrine glands shaving were used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Subcutaneous apocrine glands shaving</intervention_name>
    <description>A 0.5-cm long incision was made in the identified elliptical surgical area at each axilla for the access of arthroscopy to remove the apocrine glands. A suction-assisted cartilage shaver (E9005 System, Linvatec Corporation, Largo, Florida, USA) was introduced through the incisions to remove of the subcutaneous apocrine glands radially. After defatting, the incisions were closed primarily with 4-0 polyglactin. We anchored the defatting skin to the axillary fascia by 4-0 nylon sutures instead of the tie-over dressing or tissue glues, and we also made several drainage holes by inserting an 18G needle obliquely into the defatting skin. Therefore, draining tubes were no longer needed. We will remove the stiches at the 8th day after the operation.</description>
    <arm_group_label>Axillary osmidrosis patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with axillary osmidrosis and require surgical intervention.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with moderate to severe axillary osmidrosis and require surgical&#xD;
             intervention.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with bleeding tendency were excluded.&#xD;
&#xD;
          -  Patients with active infections.&#xD;
&#xD;
          -  Patients with major cardiovascular diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shang-Hung Lin, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yu-Ju Tseng, M.D.</last_name>
    <phone>+886961123176</phone>
    <email>yuju311@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Chang Gung Memorial Hospital</name>
      <address>
        <city>Kaohsiung City</city>
        <zip>83301</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yu-Ju Tseng, M.D.</last_name>
      <phone>+886961123176</phone>
      <email>yuju311@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Yoshikata R, Yanai A, Takei T, Shionome H. Surgical treatment of axillary osmidrosis. Br J Plast Surg. 1990 Jul;43(4):483-5. doi: 10.1016/0007-1226(90)90019-v. No abstract available.</citation>
    <PMID>2393776</PMID>
  </reference>
  <reference>
    <citation>Wu WH. Ablation of apocrine glands with the use of a suction-assisted cartilage shaver for treatment of axillary osmidrosis: an analysis of 156 cases. Ann Plast Surg. 2009 Mar;62(3):278-83. doi: 10.1097/SAP.0b013e3181776398.</citation>
    <PMID>19240525</PMID>
  </reference>
  <reference>
    <citation>Chern E, Yau D, Chuang FC, Wu WM. Arthroscopic shaver with refinement for axillary osmidrosis. Int J Dermatol. 2010 Jul;49(7):813-7. doi: 10.1111/j.1365-4632.2010.04540.x.</citation>
    <PMID>20618505</PMID>
  </reference>
  <reference>
    <citation>Lee JC, Kuo HW, Chen CH, Juan WH, Hong HS, Yang CH. Treatment for axillary osmidrosis with suction-assisted cartilage shaver. Br J Plast Surg. 2005 Mar;58(2):223-7. doi: 10.1016/j.bjps.2004.07.002.</citation>
    <PMID>15710118</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 28, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chang Gung Memorial Hospital</investigator_affiliation>
    <investigator_full_name>Shang-Hung Lin</investigator_full_name>
    <investigator_title>Attending physician of the Department of Dermatology of Kaohsiung Chang Gung Memorial Hospital</investigator_title>
  </responsible_party>
  <keyword>Axillary osmidrosis</keyword>
  <keyword>Surgery</keyword>
  <keyword>Cartilage shaver</keyword>
  <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/NCT03793374
org study id: 201801926B0
nct id: NCT03793374
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study included patients who suffered from moderate to severe axillary osmidrosis to
      receive the modified suction-assisted cartilage shaver, and evaluated the efficacy and
      complications.
<Patients> After obtaining the agreement of Chang Gung Medical Foundation Institutional
      Review Board, the investigators retrospectively included patients from July 2013 to September
      2017. There were 39 patients treated for AO by the same dermatologist with suction-assisted
      cartilage shaver at the Department of Dermatology, Chang Gung Memorial Hospital, Kaohsiung,
      Taiwan. There were 28 females and 11 males, ranging from 14 to 52 years of age. The
      participants were all bothered by the axillary osmidrosis, which had a huge impact on their
      daily life with the embarrassing malodors. Operations were performed under local anaesthesia
      and in an outpatient basis.

      <Operation> During the procedure, both of patient's axillae were exposed with the patient
      lying supine and arms abducted to avoid injury to the brachial plexus. The investigator cut
      the axillary hair short for better visualizing the region of apocrine glands, which are
      located near the hair follicles. The hair bearing elliptical region of axilla was marked
      before hair cutting. Tumescent solution was prepared with 0.1% lidocaine, 1:500,000
      epinephrine and 10mEq/L sodium bicarbonate. The investigator injected the tumescent solution
      to the subcutaneous level of each axilla in view of the hydro-dissection ability of tumescent
      and minimizing the bleeding.

      A 0.5-cm long incision was made in the center of identified elliptical surgical area at each
      axilla for the better access of arthroscopy to remove the apocrine glands located at
      dermo-subcutaneous junction, and for hiding the scar in the skin crease to make it less
      noticeable. A suction-assisted cartilage shaver (E9005 System, Linvatec Corporation, Largo,
      Florida, USA) was introduced through the incisions to remove of the subcutaneous tissue
      containing the apocrine glands radially. The investigator set the system to keep the inner
      cannula at 1500 rotations per minute in oscillation mode. After defatting, the incisions were
      closed primarily with 4-0 polyglactin. The investigator anchored the defatting skin to the
      axillary fascia by using 4-0 nylon sutures instead of the tie-over dressing used in the
      conventional shaver procedure, and the investigator also made several drainage holes by
      inserting an 18G needle obliquely into the defatting skin rather than placing the drainage
      tubes used in the conventional shaver procedure. Therefore, draining tubes were no longer
      needed. The investigator will remove the stitches at the 8th day after the operation.

      <Efficacy assessments> The participants' medical history, physical examinations, and vital
      signs were carefully collected before the operation. The investigators retrospectively
      evaluated the pre- and post-operative clinical efficacies with a patient-centered scoring
      method. The severity of AO before the operation was classified from 1 to 5 to indicate the
      least severe to the most severe condition, from undetectable, mild, moderate, severe, to
      unbearable of malodor. The clinical efficacy was classified to 5 grades: poor (0%-20%), fair
      (21%-39%), acceptable (40%- 59%), good(60%-79%), and excellent (80%-100%), which was
      evaluated based on the elimination of malodor and the post-operative satisfaction. To
      evaluate the safety, adverse reactions such as hematoma, seroma, infection, wound necrosis,
      skin necrosis or perforation, and scar formation were recorded.
observational model: Case-Only
time perspective: Retrospective
measure: The change of malodor of axillary osmidorsis after the modified suction-assiated cartilage shaver
time frame: The treatment efficacy is evaluated 1 year after the surgery.
description: The efficacy of surgical treatment for axillary osmidrosis is evaluated by the change of the malodor. The degree of malodor is subjective, therefore, the investigators classified the degree of malodor from 1 to 5 to indicate the least severe to the most sever condition. The degree of malodor was recorded before the operation, 1 month after the operation, and 1 year after the operation. The investigators evaluate the efficacy of the surgical treatment by the changes of the degree of the malodor of axillary osmidrosis.
measure: The rate of complications of the modified suction-assiated cartilage shaver for axillary osmidrosis
time frame: The immediate and longterm complications are recorded and evaluated at 1 week and 1 year respectively after the surgery.
description: To evaluate the safety of the modified surgical method, adverse reactions such as hematoma, seroma, infection, wound necrosis, skin necrosis or perforation, and scar formation were recorded and evaluated.
arm group label: Axillary osmidrosis patients
description: Patients with axillary malodor and require surgical intervention. The subcutaneous apocrine glands shaving were used.
intervention type: Other
intervention name: Subcutaneous apocrine glands shaving
description: A 0.5-cm long incision was made in the identified elliptical surgical area at each axilla for the access of arthroscopy to remove the apocrine glands. A suction-assisted cartilage shaver (E9005 System, Linvatec Corporation, Largo, Florida, USA) was introduced through the incisions to remove of the subcutaneous apocrine glands radially. After defatting, the incisions were closed primarily with 4-0 polyglactin. We anchored the defatting skin to the axillary fascia by 4-0 nylon sutures instead of the tie-over dressing or tissue glues, and we also made several drainage holes by inserting an 18G needle obliquely into the defatting skin. Therefore, draining tubes were no longer needed. We will remove the stiches at the 8th day after the operation.
arm group label: Axillary osmidrosis patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Shang-Hung Lin, M.D.
role: Principal Investigator
affiliation: Chang Gung Memorial Hospital
last name: Yu-Ju Tseng, M.D.
phone: +886961123176
email: yuju311@gmail.com
facility: 
status: Recruiting
contact: 
country: Taiwan
citation: Yoshikata R, Yanai A, Takei T, Shionome H. Surgical treatment of axillary osmidrosis. Br J Plast Surg. 1990 Jul;43(4):483-5. doi: 10.1016/0007-1226(90)90019-v. No abstract available.
PMID: 2393776
citation: Wu WH. Ablation of apocrine glands with the use of a suction-assisted cartilage shaver for treatment of axillary osmidrosis: an analysis of 156 cases. Ann Plast Surg. 2009 Mar;62(3):278-83. doi: 10.1097/SAP.0b013e3181776398.
PMID: 19240525
citation: Chern E, Yau D, Chuang FC, Wu WM. Arthroscopic shaver with refinement for axillary osmidrosis. Int J Dermatol. 2010 Jul;49(7):813-7. doi: 10.1111/j.1365-4632.2010.04540.x.
PMID: 20618505
citation: Lee JC, Kuo HW, Chen CH, Juan WH, Hong HS, Yang CH. Treatment for axillary osmidrosis with suction-assisted cartilage shaver. Br J Plast Surg. 2005 Mar;58(2):223-7. doi: 10.1016/j.bjps.2004.07.002.
PMID: 15710118
responsible party type: Principal Investigator
investigator affiliation: Chang Gung Memorial Hospital
investigator full name: Shang-Hung Lin
investigator title: Attending physician of the Department of Dermatology of Kaohsiung Chang Gung Memorial Hospital
sharing ipd: No