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/NCT06024187</url>
    </required_header>
    <id_info>
      <org_study_id>SYSKY-2022-371-02</org_study_id>
      <nct_id>NCT06024187</nct_id>
    </id_info>
    <brief_title>Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial</brief_title>
    <official_title>Necrosis After Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Prospective Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</source>
    <oversight_info>
      <has_dmc>Yes</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 purpose of this study is to analyze whether cold dissection can decrease the rate of&#xD;
        ischemia necrosis and other complications and then increase the aesthetic outcomes compared&#xD;
        to electrocautery. The purpose of this study is to analyze whether cold dissection can&#xD;
        decrease the rate of ischemia necrosis and other complications and then increase the&#xD;
        aesthetic outcomes compared to electrocautery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Breast cancer is the most common cancer among women in the world. Although breast-conserving&#xD;
        surgery is a viable option for patients, mastectomy remains the choice of treatment. Despite&#xD;
        oncologic and surgical safety of nipple-sparing mastectomy(NSM) with immediate breast&#xD;
        reconstruction(IBR) were amply demonstrated, a number of acute and late complications can&#xD;
        occur. Surgical technique may play a role in the postoperative outcomes of mastectomy skin&#xD;
        flap.Previous studies suggest that cold dissection with scissors or scalpel, may lead to&#xD;
        decreasing blood loss and rates of skin necrosis, compared to electrocautery. A retrospective&#xD;
        study by Troy Ng demonstrated that the use of cold dissection is likely to decrease the rate&#xD;
        of partial-thickness necrosis (13.0%→33.3%, p=0.01) and full-thickness necrosis (1.3%→12.8%,&#xD;
        p=0.02). The purpose of this study is to analyze whether cold dissection can decrease the&#xD;
        rate of ischemia necrosis and other complications and then increase the aesthetic outcomes&#xD;
        compared to electrocautery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2022</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Patients who met the inclusion criteria and received informed consent were randomly assigned to the group of using cold separation or the group of using electrocautery with 1:1 allocation based on a computer-generated randomization schedule. The randomization was conducted by drawing an envelope containing the allocation to one of the two intervention groups.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Tissue necrosis rate</measure>
      <time_frame>within one year post operation</time_frame>
      <description>Tissue necrosis included nipple-areolar complex (NAC) and skin flap necrosis. NAC/skin flap necrosis could present as minor superficial epidermolysis requiring local wound care only, or full-thickness necrosis with any exposure of acellular dermal matrix, muscle, implant, or with full-thickness eschar that required surgical reoperation of debridement and repair.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Surgical-site infection rate(SSI)</measure>
      <time_frame>within one year post operation</time_frame>
      <description>the incidence of surgical-site infection will be compared between two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence of postoperative complications</measure>
      <time_frame>within one year post operation</time_frame>
      <description>the incidence of seroma, hematoma, blister, implant capsular contracture, and implant loss will be compared between two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cosmetic outcomes evaluated by 5-point Likert Scale</measure>
      <time_frame>Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.</time_frame>
      <description>Evaluated by patients and five surgeons. In this scale, breast fullness; nipple-areola complex, shape, and contour; scar appearance, size, and fullness; and overall breast appearance will be assessed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported outcomes (as measured using the BREAST-Q score)</measure>
      <time_frame>Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.</time_frame>
      <description>The modules included Satisfaction with Breasts, Psychosocial Wellbeing, Sexual Wellbeing, and Physical Wellbeing Chest, Surgeon, Medical Staff, Office Staff.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>Evaluated at the first day, second day, third day and the first week, second week.</time_frame>
      <description>Pain was assessed using a visual analogue scale(VAS), where 0 = no pain and 10 = worst possible pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total operation time</measure>
      <time_frame>Immediate post operation</time_frame>
      <description>Defined as the time calculated from the skin incision to the end of wound closure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Intraoperative estimated blood loss</measure>
      <time_frame>Immediate post operation</time_frame>
      <description>Blood loss (ml) during operation was compared between groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Drain volume</measure>
      <time_frame>within three days post operation</time_frame>
      <description>Total drain volume(ml) within three days post operation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of hospital stay post operation</measure>
      <time_frame>Within 2 weeks of operation.</time_frame>
      <description>Duration of hospital stay post operation(d) will be compared between two group.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight of the excised gland</measure>
      <time_frame>Immediate post operation</time_frame>
      <description>Mean mastectomy weight of patients will be compared between two groups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Size of implant</measure>
      <time_frame>Immediate post operation</time_frame>
      <description>Size of implant will be compared between two groups.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">234</enrollment>
    <condition>Breast Neoplasms</condition>
    <arm_group>
      <arm_group_label>Cold Dissection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Electrocautery Dissection</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>In this group, the septa between the skin flap and parenchyma was dissected using with electrocautery</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Cold dissection</intervention_name>
      <description>The subcutaneous flap dissection was performed with a scissor in this group. The boundary of mastectomy flap was defined as the edge of clavicle superiorly, the edge of sternum medially, the edge of inframammary fold inferiorly, and the edge of the latissimus dorsi laterally. Our tumescent technique utilizes a solution made by mixing 0.2ml of epinephrine with 250 ml of 0.9% Sodium Chloride solution to create a 1‰ ratio. 150ml to 150ml of the solution was injected into the subcutaneous tissue of the operated breast with a 20-gauge spinal needle to establish a bloodless plane. The septa between the skin flap and parenchyma then was dissected using a scissor.</description>
      <arm_group_label>Cold Dissection</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Electrocautery Dissection</intervention_name>
      <description>The subcutaneous flap dissection was performed with electrocautery in this group. The boundary of mastectomy flap was defined as the edge of clavicle superiorly, the edge of sternum medially, the edge of inframammary fold inferiorly, and the edge of the latissimus dorsi laterally.</description>
      <arm_group_label>Electrocautery Dissection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Tumor smaller than 5 cm&#xD;
  &#xD;
            -  No evidence of NAC, skin or chest wall invasion.&#xD;
  &#xD;
            -  The general inclusion criteria or pre-requisite for nipple sparing mastectomy apply to&#xD;
               E-NSM as well.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with apparent NAC involvement, chest wall or skin invasion, inflammatory&#xD;
               breast cancer, locally advanced breast cancer or severe comorbid conditions or poor&#xD;
               performance status assessed by the primary physicians, such as heart disease, renal&#xD;
               failure, liver dysfunction, and poor performance status as assessed by the primary&#xD;
               physicians.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shicheng Su</last_name>
      <role>Principal Investigator</role>
      <affiliation>Sun Yat-sen Memorial Hospital,Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shicheng Su</last_name>
      <phone>+86 13631304227</phone>
      <email>sushch@mail.sysu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Shicheng Su</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510120</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Shicheng Su, M.D.,Ph.D.</last_name>
        <phone>+8613631304227</phone>
        <email>sushch@mail.sysu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>November 30, 2022</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Endoscopy</keyword>
    <keyword>Mastectomy</keyword>
    <keyword>Breast Implants</keyword>
    <keyword>Necrosis</keyword>
    <keyword>Dissection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
    </condition_browse>
    <!-- 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/NCT06024187
  org study id: SYSKY-2022-371-02
  nct id: NCT06024187
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to analyze whether cold dissection can decrease the rate of
        ischemia necrosis and other complications and then increase the aesthetic outcomes compared
        to electrocautery. The purpose of this study is to analyze whether cold dissection can
        decrease the rate of ischemia necrosis and other complications and then increase the
        aesthetic outcomes compared to electrocautery.
  Breast cancer is the most common cancer among women in the world. Although breast-conserving
        surgery is a viable option for patients, mastectomy remains the choice of treatment. Despite
        oncologic and surgical safety of nipple-sparing mastectomy(NSM) with immediate breast
        reconstruction(IBR) were amply demonstrated, a number of acute and late complications can
        occur. Surgical technique may play a role in the postoperative outcomes of mastectomy skin
        flap.Previous studies suggest that cold dissection with scissors or scalpel, may lead to
        decreasing blood loss and rates of skin necrosis, compared to electrocautery. A retrospective
        study by Troy Ng demonstrated that the use of cold dissection is likely to decrease the rate
        of partial-thickness necrosis (13.0%→33.3%, p=0.01) and full-thickness necrosis (1.3%→12.8%,
        p=0.02). The purpose of this study is to analyze whether cold dissection can decrease the
        rate of ischemia necrosis and other complications and then increase the aesthetic outcomes
        compared to electrocautery.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Patients who met the inclusion criteria and received informed consent were randomly assigned to the group of using cold separation or the group of using electrocautery with 1:1 allocation based on a computer-generated randomization schedule. The randomization was conducted by drawing an envelope containing the allocation to one of the two intervention groups.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Tissue necrosis rate
  time frame: within one year post operation
  description: Tissue necrosis included nipple-areolar complex (NAC) and skin flap necrosis. NAC/skin flap necrosis could present as minor superficial epidermolysis requiring local wound care only, or full-thickness necrosis with any exposure of acellular dermal matrix, muscle, implant, or with full-thickness eschar that required surgical reoperation of debridement and repair.
  measure: Surgical-site infection rate(SSI)
  time frame: within one year post operation
  description: the incidence of surgical-site infection will be compared between two groups
  measure: The incidence of postoperative complications
  time frame: within one year post operation
  description: the incidence of seroma, hematoma, blister, implant capsular contracture, and implant loss will be compared between two groups
  measure: Cosmetic outcomes evaluated by 5-point Likert Scale
  time frame: Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.
  description: Evaluated by patients and five surgeons. In this scale, breast fullness; nipple-areola complex, shape, and contour; scar appearance, size, and fullness; and overall breast appearance will be assessed.
  measure: Patient-reported outcomes (as measured using the BREAST-Q score)
  time frame: Evaluated pre-operation, at the first month, at 2 months, 3 months, 6 months and 12 months.
  description: The modules included Satisfaction with Breasts, Psychosocial Wellbeing, Sexual Wellbeing, and Physical Wellbeing Chest, Surgeon, Medical Staff, Office Staff.
  measure: Postoperative pain
  time frame: Evaluated at the first day, second day, third day and the first week, second week.
  description: Pain was assessed using a visual analogue scale(VAS), where 0 = no pain and 10 = worst possible pain.
  measure: Total operation time
  time frame: Immediate post operation
  description: Defined as the time calculated from the skin incision to the end of wound closure
  measure: Intraoperative estimated blood loss
  time frame: Immediate post operation
  description: Blood loss (ml) during operation was compared between groups
  measure: Drain volume
  time frame: within three days post operation
  description: Total drain volume(ml) within three days post operation
  measure: Duration of hospital stay post operation
  time frame: Within 2 weeks of operation.
  description: Duration of hospital stay post operation(d) will be compared between two group.
  measure: Weight of the excised gland
  time frame: Immediate post operation
  description: Mean mastectomy weight of patients will be compared between two groups.
  measure: Size of implant
  time frame: Immediate post operation
  description: Size of implant will be compared between two groups.
  arm group label: Cold Dissection
  arm group type: Experimental
  description: In this group, the septa between the skin flap and parenchyma was dissected using with scissors or scalpel
  arm group label: Electrocautery Dissection
  arm group type: Active Comparator
  description: In this group, the septa between the skin flap and parenchyma was dissected using with electrocautery
  intervention type: Procedure
  intervention name: Cold dissection
  description: The subcutaneous flap dissection was performed with a scissor in this group. The boundary of mastectomy flap was defined as the edge of clavicle superiorly, the edge of sternum medially, the edge of inframammary fold inferiorly, and the edge of the latissimus dorsi laterally. Our tumescent technique utilizes a solution made by mixing 0.2ml of epinephrine with 250 ml of 0.9% Sodium Chloride solution to create a 1‰ ratio. 150ml to 150ml of the solution was injected into the subcutaneous tissue of the operated breast with a 20-gauge spinal needle to establish a bloodless plane. The septa between the skin flap and parenchyma then was dissected using a scissor.
  arm group label: Cold Dissection
  intervention type: Procedure
  intervention name: Electrocautery Dissection
  description: The subcutaneous flap dissection was performed with electrocautery in this group. The boundary of mastectomy flap was defined as the edge of clavicle superiorly, the edge of sternum medially, the edge of inframammary fold inferiorly, and the edge of the latissimus dorsi laterally.
  arm group label: Electrocautery Dissection
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Shicheng Su
  role: Principal Investigator
  affiliation: Sun Yat-sen Memorial Hospital,Sun Yat-sen University
  last name: Shicheng Su
  phone: +86 13631304227
  email: sushch@mail.sysu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Breast Neoplasms