<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/NCT02206477</url>
  </required_header>
  <id_info>
    <org_study_id>0005-13-RMC</org_study_id>
    <nct_id>NCT02206477</nct_id>
  </id_info>
  <brief_title>DMSO for Prevention of Capsular Contraction in Alloplastic Breast Reconstruction</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Capsular contraction is the one of the most common complications of both esthetic and&#xD;
      reconstructive breast surgery, with high incidence after radiotherapy. The mechanism of the&#xD;
      contraction is unclear, but is believed to be similar to the formation of hypertrophic&#xD;
      scarring.&#xD;
&#xD;
      Dimethyl sulfoxide (DMSO) has demonstrated its use as an anti-inflammatory,&#xD;
      anti-proliferative, and antibacterial agent.&#xD;
&#xD;
      The aim of this study is to test the effect of DMSO on the incidence and severity if capsular&#xD;
      contracture after breast alloplastic reconstruction in irradiated patients.&#xD;
&#xD;
      We conduct a prospective randomized-control single-surgeon study in the tertiary academic&#xD;
      Rabin Medical Center.&#xD;
&#xD;
      110 female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction&#xD;
      will be included. They will be divided into two groups: the DMSO treatment group, which will&#xD;
      be treated according to our protocol, and the control group, that will be treated with the&#xD;
      same protocol but with 0.9% saline instead.&#xD;
&#xD;
      Several measures will be taken, including: capsular contracture grading by two plastic&#xD;
      surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography&#xD;
      evaluation, and pathology examination of the capsule (biopsy will be taken during the second&#xD;
      stage operation).&#xD;
&#xD;
      Rates and grades of capsular contracture evident clinically, radiologically and&#xD;
      pathologically, will be evaluated and compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <phase>Phase 2/Phase 3</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>reduction of 50% or more in capsular contructure incidence</measure>
    <time_frame>3.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>reduction in maximal capsular thickness (MCT) in sonography evaluation</measure>
    <time_frame>3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>evidence of less inflamation and fibrosis in pathology examination of the capsule</measure>
    <time_frame>3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>reduction in VAS pain score in treatment group</measure>
    <time_frame>3.5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Breast Capsular Contracture</condition>
  <condition>Dimethyl Sulfoxide</condition>
  <arm_group>
    <arm_group_label>DMSO treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The treatment group will be exposed to DMSO according to our built protocol. On the seventh post-operative day, the patient will be guided to set 10 cc of DMSO soaked gauze compresses on the breast, twice a day for 20 minutes, for the term of 6 weeks. This treatment will be holed for 24 hours on tissue expander inflation dates. A repeated course of compresses will be taken after adjuvant radiotherapy, starting 24 hours after the last therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control group will be treated with the same post-operative protocol, but with 0.9% saline instead of DMSO. On the seventh post-operative day, the patient will be guided to set 10 cc 0.9% saline soaked gauze compresses on the breast, twice a day for 20 minutes, for the term of 6 weeks. This treatment will be holed for 24 hours on tissue expander inflation dates. A repeated course of compresses will be taken after adjuvant radiotherapy, starting 24 hours after the last therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dimethyl Sulfoxide</intervention_name>
    <arm_group_label>DMSO treatment group</arm_group_label>
    <other_name>DMSO</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline 0.9%</intervention_name>
    <arm_group_label>the control group</arm_group_label>
    <other_name>normal saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  autologous reconstruction&#xD;
&#xD;
          -  single-stage alloplastic reconstruction&#xD;
&#xD;
          -  intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications&#xD;
             on a regular basis&#xD;
&#xD;
          -  low compliance to home treatment or follow-ups.&#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>Sagit Meshulam Derazon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rabin Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sagit Meshulam Derazon, MD</last_name>
    <phone>+97239376366</phone>
    <email>sagitmd@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Rabin Medical Center</name>
      <address>
        <city>Petach Tikva</city>
        <country>Israel</country>
      </address>
    </facility>
    <investigator>
      <last_name>Sagit Meshulam Derazon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 31, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>July 31, 2014</last_update_submitted>
  <last_update_submitted_qc>July 31, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>Sagit Meshulam-Derazon</investigator_full_name>
    <investigator_title>MD; Head of breast reconstruction unit</investigator_title>
  </responsible_party>
  <keyword>breast capsular contructure</keyword>
  <keyword>dimethyl sulfoxide</keyword>
  <keyword>radiotherapy</keyword>
  <keyword>breast reconstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Contracture</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dimethyl Sulfoxide</mesh_term>
  </intervention_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/NCT02206477
org study id: 0005-13-RMC
nct id: NCT02206477
lead sponsor: 
has dmc: Yes
Capsular contraction is the one of the most common complications of both esthetic and
      reconstructive breast surgery, with high incidence after radiotherapy. The mechanism of the
      contraction is unclear, but is believed to be similar to the formation of hypertrophic
      scarring.

      Dimethyl sulfoxide (DMSO) has demonstrated its use as an anti-inflammatory,
      anti-proliferative, and antibacterial agent.

      The aim of this study is to test the effect of DMSO on the incidence and severity if capsular
      contracture after breast alloplastic reconstruction in irradiated patients.

      We conduct a prospective randomized-control single-surgeon study in the tertiary academic
      Rabin Medical Center.

      110 female candidates for mastectomy, radiotherapy and immediate two-stage reconstruction
      will be included. They will be divided into two groups: the DMSO treatment group, which will
      be treated according to our protocol, and the control group, that will be treated with the
      same protocol but with 0.9% saline instead.

      Several measures will be taken, including: capsular contracture grading by two plastic
      surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography
      evaluation, and pathology examination of the capsule (biopsy will be taken during the second
      stage operation).

      Rates and grades of capsular contracture evident clinically, radiologically and
      pathologically, will be evaluated and compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: reduction of 50% or more in capsular contructure incidence
time frame: 3.5 years
measure: reduction in maximal capsular thickness (MCT) in sonography evaluation
time frame: 3.5 years
measure: evidence of less inflamation and fibrosis in pathology examination of the capsule
time frame: 3.5 years
measure: reduction in VAS pain score in treatment group
time frame: 3.5 years
arm group label: DMSO treatment group
arm group type: Experimental
description: The treatment group will be exposed to DMSO according to our built protocol. On the seventh post-operative day, the patient will be guided to set 10 cc of DMSO soaked gauze compresses on the breast, twice a day for 20 minutes, for the term of 6 weeks. This treatment will be holed for 24 hours on tissue expander inflation dates. A repeated course of compresses will be taken after adjuvant radiotherapy, starting 24 hours after the last therapy.
arm group label: the control group
arm group type: Placebo Comparator
description: The control group will be treated with the same post-operative protocol, but with 0.9% saline instead of DMSO. On the seventh post-operative day, the patient will be guided to set 10 cc 0.9% saline soaked gauze compresses on the breast, twice a day for 20 minutes, for the term of 6 weeks. This treatment will be holed for 24 hours on tissue expander inflation dates. A repeated course of compresses will be taken after adjuvant radiotherapy, starting 24 hours after the last therapy.
intervention type: Drug
intervention name: Dimethyl Sulfoxide
arm group label: DMSO treatment group
other name: DMSO
intervention type: Drug
intervention name: Saline 0.9%
arm group label: the control group
other name: normal saline
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sagit Meshulam Derazon, MD
role: Principal Investigator
affiliation: Rabin Medical Center
last name: Sagit Meshulam Derazon, MD
phone: +97239376366
email: sagitmd@gmail.com
facility: 
investigator: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rabin Medical Center
investigator full name: Sagit Meshulam-Derazon
investigator title: MD; Head of breast reconstruction unit
mesh term: Contracture
mesh term: Dimethyl Sulfoxide