<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/NCT04471142</url>
  </required_header>
  <id_info>
    <org_study_id>Instituto Nacional do Câncer</org_study_id>
    <nct_id>NCT04471142</nct_id>
  </id_info>
  <brief_title>Effectiveness of Compressive Bandage Use in Seroma Prevention</brief_title>
  <official_title>Effectiveness of Compressive Bandage Use in Post-Treatment Seroma Prevention Breast Cancer Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Nacional de Cancer, Brazil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Nacional de Cancer, Brazil</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      INTRODUCTION: Seroma is the most common complication after surgical treatment for breast&#xD;
      cancer. It is the abnormal accumulation of serous fluid that develops under skin flaps and&#xD;
      may be associated with necrosis, dehiscence, sepsis, and shoulder dysfunction. The&#xD;
      therapeutic bandage has been inserted in clinical practice because it is similar to the&#xD;
      elasticity of the skin and is able to help the circulatory and lymphatic system, reduce pain&#xD;
      and local swelling, and may have benefits for prevention and treatment of seroma when applied&#xD;
      compressively. . OBJECTIVE: To evaluate the effectiveness of compressive bandage in&#xD;
      preventing seroma. METHODOLOGY: Randomized study of women over 18 years who underwent&#xD;
      mastectomy at HCIII / INCA. Eligible patients will be allocated to the intervention and&#xD;
      control groups by lot (270 envelopes, 135 patients per group). The intervention group, in&#xD;
      addition to the use of the drain, will be submitted to the compression bandage on the day of&#xD;
      hospital discharge and will be reevaluated on the seventh day. The control group will follow&#xD;
      the institutional routine, using only the drain. The incidence and volume of the seroma, as&#xD;
      well as the length of stay of the drain will be evaluated after 30 days through the medical&#xD;
      record. Symptoms and skin changes resulting from the use of the bandage will be evaluated&#xD;
      through a specific form. ANALYSIS: Descriptive analysis will be by measures of central&#xD;
      tendency, dispersion and frequency distribution. Outcome assessment will be performed by odds&#xD;
      ratio (for categorical variables) and by mean difference (Student's t-test), considering a&#xD;
      95% confidence interval. To control the confounding variables, multiple logistic regression&#xD;
      (categorical outcome) and multiple linear regression (continuous outcome) will be performed&#xD;
      by the Stepwise Forward method, including variables with p &lt;0.20.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized clinical trial with women undergoing surgical treatment for breast&#xD;
      cancer at Cancer Hospital III / INCA. All patients undergoing mastectomy will be evaluated&#xD;
      for eligibility criteria after the first dressing in the hospital, those considered eligible&#xD;
      will be informed about the study and no obligation to participate through free and informed&#xD;
      consent. Upon acceptance, patients will be randomized to the intervention or control group,&#xD;
      which will be performed by lot at the time the patient enters the study. 27 blocks will be&#xD;
      available containing 10 envelopes where 05 will contain a code that allocates the patients in&#xD;
      group A and 05 in group B. This choice was chosen to avoid influences of the therapist or&#xD;
      patient's preference over the intervention. The patients will be oriented in relation to the&#xD;
      group they are inserted and what monitoring will be performed while the patient is under the&#xD;
      care of the dressing. All evaluations, intervention and data collection will be performed by&#xD;
      trained professionals qualified for this purpose. Group A: intervention group with preventive&#xD;
      application of compressive bandage in addition to the suction drain (routine adopted in the&#xD;
      institution). Patients allocated to this group on the day of the first dressing, before&#xD;
      hospital discharge, according to the institutional routine, are instructed by the nursing&#xD;
      staff to wash the plastron region with cold, boiled filtered water and to return within one&#xD;
      week at the outpatient clinic. The bandage will be applied on the day of discharge after the&#xD;
      first dressing, withdrawal and new bandage applied on the fourth day and definitive removal&#xD;
      on the seventh day when it will be scheduled for return in nursing care. Should any&#xD;
      complications occur due to the use of the bandage, the patients will be advised to remove the&#xD;
      material at home and will be suspended from the research protocol. At the end of the seven&#xD;
      days, the patients will be reevaluated. Prior to the application of the bandage will be made&#xD;
      the antisepsis of the skin and placement of the transparent and sterile film dressing over&#xD;
      the region of the scar points to protect the scar. The 5 cm wide Vitaltape® neuromuscular&#xD;
      bandage will be used with maximum stretching over the plastron region and finished with two&#xD;
      ends of two to three centimeters without stretching. As many bundles of bandages as necessary&#xD;
      will be applied according to the patient's body characteristics. All applications will be&#xD;
      performed by the same physical therapist. Group B: control group. The patient will follow the&#xD;
      institution's routine only with the suction drain. All patients will be instructed to do the&#xD;
      same care with the suction drain according to the institutional routine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 8, 2021</start_date>
  <completion_date type="Anticipated">March 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>All patients undergoing mastectomy will be evaluated for eligibility criteria after the first dressing, those considered eligible will be randomized to the intervention or control group. 27 blocks will be available containing 10 envelopes where 05 will contain a code that allocates the patients in group A and 05 in group B. Group A: intervention group with preventive application of compressive bandage in addition to the suction drain (routine adopted in the institution). The bandage will be applied on the day of discharge after the first dressing, withdrawal and new bandage applied on the fourth day and permanently removed on the seventh day when they will be reevaluated. Group B: control group. Patient will follow the routine of the institution only with the suction drain.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroma Incidence</measure>
    <time_frame>30 days</time_frame>
    <description>the presence of assessed local fluctuation will be considered seroma by the nursing team during dressing care, with indication of puncture aspiration to resolve the condition, regardless of the volume drained.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroma volume</measure>
    <time_frame>30 days</time_frame>
    <description>the total volume drained and the number of aspirations will be considered necessary until resolution of the picture.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Permanence time with the Suction Drain</measure>
    <time_frame>15 days</time_frame>
    <description>The permanence time (in days) will be checked with the suction drain, as reported by the dressing team.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of the use of the compressive bandage in mastectomized women</measure>
    <time_frame>7 days</time_frame>
    <description>The dermal changes will be evaluated at the location of the bandage application of the 135 participants in the intervention group, such as discoloration, increased local temperature, skin peeling, presence of a wound and formation of bullous lesions at the site of the application of the neuromuscular bandage, graded in light, moderate or severe, according to the severity of the change, from a semi-structured questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the tolerance reported by the patient to the use of compressive taping</measure>
    <time_frame>7 days</time_frame>
    <description>The symptoms of pain, itching, burning, discomfort, tightness, increased fluctuation of the seroma at the site of application of the bandage of the 135 participants will be evaluated. The symptoms will be graded according to the Visual Numeric Scale (0-10), where 0 will be considered no sensation and 10 unbearable sensation with the use of the bandage.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Seroma</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group with preventive application of compressive bandages in addition to suction drain (routine adopted at the institution).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Group control. The patient will follow the institution's routine with only the suction drain.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>neuromuscular bandage</intervention_name>
    <description>After the dressing is performed by the nursing team with a sterile gauze covering over the region of the healing points, the 7 cm wide Vitaltape® neuromuscular bandage will be applied. For the application of the bandage, maximum stretching will be performed over the region of the plastron and finished with the two ends, from two to three centimeters, without stretching. As many bundles of bandages as necessary will be applied according to the patient's body characteristics.</description>
    <arm_group_label>Group A</arm_group_label>
    <other_name>compressive taping</other_name>
    <other_name>compressiva bandage</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18 and over&#xD;
&#xD;
          -  underwent mastectomy assurgical treatment for breast cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  bilateral breast cancer;&#xD;
&#xD;
          -  patient undergoing neoadjuvant radiotherapy;&#xD;
&#xD;
          -  infection in the surgical wound or hematoma;&#xD;
&#xD;
          -  autoimmune disease reporting (dermatomyositis, hidradenitis suppurativa, nephropathy,&#xD;
             lupus erythematosus, morphea, psoriasis, pemphigus vulgaris, scleroderma);&#xD;
&#xD;
          -  patients with difficulties in understanding.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erica Fabro, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>INCA - Brazil</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erica Fabro, Master</last_name>
    <phone>55 21 993971746</phone>
    <email>efabro@inca.gov.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anke Bergamnn, Doctor</last_name>
    <phone>55 21 32076551</phone>
    <email>abergmann@inca.gov.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Erica Alves Nogueira Fabro</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>20530-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Nacional de Cancer, Brazil</investigator_affiliation>
    <investigator_full_name>Erica Alves Nogueira Fabro</investigator_full_name>
    <investigator_title>INCA Effectiveness Seroma Prevention</investigator_title>
  </responsible_party>
  <keyword>physiotherapy</keyword>
  <keyword>seroma</keyword>
  <keyword>breast cancer</keyword>
  <keyword>taping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seroma</mesh_term>
  </condition_browse>
  <!-- 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/NCT04471142
org study id: Instituto Nacional do Câncer
nct id: NCT04471142
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
INTRODUCTION: Seroma is the most common complication after surgical treatment for breast
      cancer. It is the abnormal accumulation of serous fluid that develops under skin flaps and
      may be associated with necrosis, dehiscence, sepsis, and shoulder dysfunction. The
      therapeutic bandage has been inserted in clinical practice because it is similar to the
      elasticity of the skin and is able to help the circulatory and lymphatic system, reduce pain
      and local swelling, and may have benefits for prevention and treatment of seroma when applied
      compressively. . OBJECTIVE: To evaluate the effectiveness of compressive bandage in
      preventing seroma. METHODOLOGY: Randomized study of women over 18 years who underwent
      mastectomy at HCIII / INCA. Eligible patients will be allocated to the intervention and
      control groups by lot (270 envelopes, 135 patients per group). The intervention group, in
      addition to the use of the drain, will be submitted to the compression bandage on the day of
      hospital discharge and will be reevaluated on the seventh day. The control group will follow
      the institutional routine, using only the drain. The incidence and volume of the seroma, as
      well as the length of stay of the drain will be evaluated after 30 days through the medical
      record. Symptoms and skin changes resulting from the use of the bandage will be evaluated
      through a specific form. ANALYSIS: Descriptive analysis will be by measures of central
      tendency, dispersion and frequency distribution. Outcome assessment will be performed by odds
      ratio (for categorical variables) and by mean difference (Student's t-test), considering a
      95% confidence interval. To control the confounding variables, multiple logistic regression
      (categorical outcome) and multiple linear regression (continuous outcome) will be performed
      by the Stepwise Forward method, including variables with p <0.20.
This is a randomized clinical trial with women undergoing surgical treatment for breast
      cancer at Cancer Hospital III / INCA. All patients undergoing mastectomy will be evaluated
      for eligibility criteria after the first dressing in the hospital, those considered eligible
      will be informed about the study and no obligation to participate through free and informed
      consent. Upon acceptance, patients will be randomized to the intervention or control group,
      which will be performed by lot at the time the patient enters the study. 27 blocks will be
      available containing 10 envelopes where 05 will contain a code that allocates the patients in
      group A and 05 in group B. This choice was chosen to avoid influences of the therapist or
      patient's preference over the intervention. The patients will be oriented in relation to the
      group they are inserted and what monitoring will be performed while the patient is under the
      care of the dressing. All evaluations, intervention and data collection will be performed by
      trained professionals qualified for this purpose. Group A: intervention group with preventive
      application of compressive bandage in addition to the suction drain (routine adopted in the
      institution). Patients allocated to this group on the day of the first dressing, before
      hospital discharge, according to the institutional routine, are instructed by the nursing
      staff to wash the plastron region with cold, boiled filtered water and to return within one
      week at the outpatient clinic. The bandage will be applied on the day of discharge after the
      first dressing, withdrawal and new bandage applied on the fourth day and definitive removal
      on the seventh day when it will be scheduled for return in nursing care. Should any
      complications occur due to the use of the bandage, the patients will be advised to remove the
      material at home and will be suspended from the research protocol. At the end of the seven
      days, the patients will be reevaluated. Prior to the application of the bandage will be made
      the antisepsis of the skin and placement of the transparent and sterile film dressing over
      the region of the scar points to protect the scar. The 5 cm wide Vitaltape® neuromuscular
      bandage will be used with maximum stretching over the plastron region and finished with two
      ends of two to three centimeters without stretching. As many bundles of bandages as necessary
      will be applied according to the patient's body characteristics. All applications will be
      performed by the same physical therapist. Group B: control group. The patient will follow the
      institution's routine only with the suction drain. All patients will be instructed to do the
      same care with the suction drain according to the institutional routine.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All patients undergoing mastectomy will be evaluated for eligibility criteria after the first dressing, those considered eligible will be randomized to the intervention or control group. 27 blocks will be available containing 10 envelopes where 05 will contain a code that allocates the patients in group A and 05 in group B. Group A: intervention group with preventive application of compressive bandage in addition to the suction drain (routine adopted in the institution). The bandage will be applied on the day of discharge after the first dressing, withdrawal and new bandage applied on the fourth day and permanently removed on the seventh day when they will be reevaluated. Group B: control group. Patient will follow the routine of the institution only with the suction drain.
primary purpose: Prevention
masking: None (Open Label)
measure: Seroma Incidence
time frame: 30 days
description: the presence of assessed local fluctuation will be considered seroma by the nursing team during dressing care, with indication of puncture aspiration to resolve the condition, regardless of the volume drained.
measure: Seroma volume
time frame: 30 days
description: the total volume drained and the number of aspirations will be considered necessary until resolution of the picture.
measure: Permanence time with the Suction Drain
time frame: 15 days
description: The permanence time (in days) will be checked with the suction drain, as reported by the dressing team.
measure: Safety of the use of the compressive bandage in mastectomized women
time frame: 7 days
description: The dermal changes will be evaluated at the location of the bandage application of the 135 participants in the intervention group, such as discoloration, increased local temperature, skin peeling, presence of a wound and formation of bullous lesions at the site of the application of the neuromuscular bandage, graded in light, moderate or severe, according to the severity of the change, from a semi-structured questionnaire.
measure: To assess the tolerance reported by the patient to the use of compressive taping
time frame: 7 days
description: The symptoms of pain, itching, burning, discomfort, tightness, increased fluctuation of the seroma at the site of application of the bandage of the 135 participants will be evaluated. The symptoms will be graded according to the Visual Numeric Scale (0-10), where 0 will be considered no sensation and 10 unbearable sensation with the use of the bandage.
arm group label: Group A
arm group type: Experimental
description: Intervention group with preventive application of compressive bandages in addition to suction drain (routine adopted at the institution).
arm group label: Group B
arm group type: No Intervention
description: Group control. The patient will follow the institution's routine with only the suction drain.
intervention type: Device
intervention name: neuromuscular bandage
description: After the dressing is performed by the nursing team with a sterile gauze covering over the region of the healing points, the 7 cm wide Vitaltape® neuromuscular bandage will be applied. For the application of the bandage, maximum stretching will be performed over the region of the plastron and finished with the two ends, from two to three centimeters, without stretching. As many bundles of bandages as necessary will be applied according to the patient's body characteristics.
arm group label: Group A
other name: compressive taping
other name: compressiva bandage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erica Fabro, Master
role: Principal Investigator
affiliation: INCA - Brazil
last name: Erica Fabro, Master
phone: 55 21 993971746
email: efabro@inca.gov.br
last name: Anke Bergamnn, Doctor
phone: 55 21 32076551
email: abergmann@inca.gov.br
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Instituto Nacional de Cancer, Brazil
investigator full name: Erica Alves Nogueira Fabro
investigator title: INCA Effectiveness Seroma Prevention
mesh term: Seroma