<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/NCT04487561</url>
  </required_header>
  <id_info>
    <org_study_id>REDHEMOPACH</org_study_id>
    <nct_id>NCT04487561</nct_id>
  </id_info>
  <brief_title>Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy</brief_title>
  <acronym>REDHEMOPACH</acronym>
  <official_title>Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy: Randomized, Controlled, Multicenter Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación para la Investigación del Hospital Clínico de Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación para la Investigación del Hospital Clínico de Valencia</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>
      Aspirative drainage continues to be the &quot;gold standard&quot; for the management of this&#xD;
      post-surgical complication, even though it can lead to complications such as obstruction of&#xD;
      the drainage, peritubal leakage of the seroma, etc. This may result in pain and reduction in&#xD;
      mobility of the affected arm.&#xD;
&#xD;
      Based on our positive clinical outcomes and the fact that there is not any published data&#xD;
      available in the literature regarding this use of the patch, the investigators propose a&#xD;
      multicentric, randomized controlled clinical trial, with the objective of comparing the&#xD;
      Hemopatch® with the usual technique used (aspirative drainage) in terms of efficacy and&#xD;
      safety.&#xD;
&#xD;
      Hypothesis: Placing a Hemopatch ® instead of an aspirative drainage in women after undergoing&#xD;
      axillary lymph node dissection during breast cancer surgery may reduce the appearance of&#xD;
      seroma and consequently the need for a puncture, as well as the complications related to&#xD;
      aspirative drainage.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Introduction:&#xD;
&#xD;
           In the surgical management of breast cancer, a conservative approach is the &quot;gold&#xD;
           standard&quot; for the mammary region. For the axillary region, however, this depends on the&#xD;
           results of the sentinel lymph node biopsy (SLNB) with axillary lymph node dissection&#xD;
           (ALND) continuing to be an indispensable procedure when the disease reaches this level.&#xD;
&#xD;
           The complications that arise from this procedure can be divided in two groups: 1) early:&#xD;
           seromas and nerve lesions and 2) late: lymphedema, functional disorders in shoulder&#xD;
           movement and post-mastectomy pain syndrome.&#xD;
&#xD;
           Seromas are the most frequent complications after an ALND. In themselves, they do not&#xD;
           carry a high risk of morbidity. However, they delay healing of the surgical wound,&#xD;
           increasing the risk of infection and number of ambulatory visits and furthermore,&#xD;
           resulting in a deferral in the start of adjuvant therapies such as radio and&#xD;
           chemotherapy.&#xD;
&#xD;
           Aspirative drainage continues to be the &quot;gold standard&quot; for the management of this&#xD;
           post-surgical complication, even though it can lead to complications such as obstruction&#xD;
           of the drainage, peritubal leakage of the seroma, etc. This may result in pain and&#xD;
           reduction in mobility of the affected arm.&#xD;
&#xD;
           Hemopatch® is a hemosthatic sealer made from reabsorbable collagen. It comes in the from&#xD;
           of patch, with CE marking that is already being used in the clinical setting in Spain&#xD;
           and the rest of Europe.&#xD;
&#xD;
           Taking into account the factors that reduce seroma formation after ALND and the&#xD;
           characteristics of the patch, its application after surgery could be useful in&#xD;
           preventing seroma formation. More specifically, the patch has proven to act as a&#xD;
&#xD;
             -  Hemosthatic, improving the first phase of inflammation&#xD;
&#xD;
             -  Adhesive, reducing the dead space left after ALND&#xD;
&#xD;
             -  Sealer, decreasing the exudate&#xD;
&#xD;
        2. Rationale Based on this premise and in the context of a clinical protocol after the&#xD;
           introduction of the patch in daily clinical practice, it was used on 28 patients that&#xD;
           underwent ALND, obtaining favourable clinical results. This is a multicentric,&#xD;
           randomized controlled clinical trial, with the objective of comparing the Hemopatch®&#xD;
           with the usual technique used (aspirative drainage) in terms of efficacy and safety.&#xD;
&#xD;
        3. Hypothesis Placing a Hemopatch ® instead of an aspirative drainage in women after&#xD;
           undergoing ALND during breast cancer surgery may reduce the appearance of seroma and&#xD;
           consequently the need for a puncture, as well as the complications related to aspirative&#xD;
           drainage.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">February 14, 2023</completion_date>
  <primary_completion_date type="Actual">February 14, 2023</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>Prospective multicentric randomized controlled clinical trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To develop seroma after surgery</measure>
    <time_frame>Percentage, through study completion, an average of 2 months</time_frame>
    <description>Percentage of patients that receive Hemopatch® that develop seroma after surgery and percentage of patients that receive that develop seroma after extraction of the aspirative drainage.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>total volumen of the seroma</measure>
    <time_frame>from 24 hours until there is no seroma, assessed up to 2 months</time_frame>
    <description>The initial control will be performed 24 hours after the intervention, maintaining AD if the volume is greater than 30ml. All patients will be seen 7 days after surgery. The follow-up time will be weekly until there is no seroma, measuring the volume of the seroma extracted by puncture,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroma punctures</measure>
    <time_frame>through study completion, an average of 2 months</time_frame>
    <description>the total number of punctures needed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>complications</measure>
    <time_frame>from 24 hours until there is no complications, assessed up to 2 months</time_frame>
    <description>Other complications collected throughout the study include: bruising (yes / no), pain (yes / no), problems with aspiration drainage (yes / no)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life in patients</measure>
    <time_frame>1 week after surgery with Eortc QLQ-BR23</time_frame>
    <description>Compare the quality of life in patients after receiving either of these procedures using the Eortc QLQ-BR23 survey</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the costs</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Compare the costs of both procedures by quantifying the costs of materials and consult time used in both procedures</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body mass index</measure>
    <time_frame>weight (kg) / height (m2). In the first consultation</time_frame>
    <description>body mass index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">228</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Breast-conserving Surgery</condition>
  <condition>Axillary Lymph Node Dissection</condition>
  <arm_group>
    <arm_group_label>aspirative drainage</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Drainage is the usual treatment after axillary lymphadenectoma for breast cancer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hemopatch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The hemopatch group will be the group without drainage and with a product patch</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>hemopatch</intervention_name>
    <description>The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma</description>
    <arm_group_label>Hemopatch</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Aspirative drainage</intervention_name>
    <description>The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma</description>
    <arm_group_label>aspirative drainage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of breast cancer,&#xD;
&#xD;
          -  scheduled for surgical treatment including conservative surgery and ALND.&#xD;
&#xD;
          -  Signed informed consent for ALND.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Selective sentinel node biopsy negative.&#xD;
&#xD;
          -  Subsidiary mastectomy patients.&#xD;
&#xD;
          -  Denial of informed consent for axillary lymphadenectomy.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Valencia</name>
      <address>
        <city>Valencia</city>
        <zip>46010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://www.eortc.org</url>
    <description>Survey of Eortc QLQ- BR23</description>
  </link>
  <link>
    <url>http://www.ncbi.nlm.nih.gov/pubmed/16286909</url>
    <description>Pathophysiology of seroma in breast cancer. Breast Cancer [Internet]. 2005;12(4):288-93.</description>
  </link>
  <reference>
    <citation>Lewis KM, Ikeme S, Olubunmi T, Kuntze CE. Clinical effectiveness and versatility of a sealing hemostatic patch (HEMOPATCH) in multiple surgical specialties. Expert Rev Med Devices. 2018 May;15(5):367-376. doi: 10.1080/17434440.2018.1464909. Epub 2018 Apr 26.</citation>
    <PMID>29658322</PMID>
  </reference>
  <reference>
    <citation>Droeser RA, Frey DM, Oertli D, Kopelman D, Baas-Vrancken Peeters MJ, Giuliano AE, Dalberg K, Kallam R, Nordmann A. Volume-controlled vs no/short-term drainage after axillary lymph node dissection in breast cancer surgery: a meta-analysis. Breast. 2009 Apr;18(2):109-14. doi: 10.1016/j.breast.2009.02.003. Epub 2009 Mar 16.</citation>
    <PMID>19289285</PMID>
  </reference>
  <reference>
    <citation>Aitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. doi: 10.1016/s0039-6109(16)43192-0. No abstract available.</citation>
    <PMID>6359504</PMID>
  </reference>
  <reference>
    <citation>Kottayasamy Seenivasagam R, Gupta V, Singh G. Prevention of seroma formation after axillary dissection--a comparative randomized clinical trial of three methods. Breast J. 2013 Sep-Oct;19(5):478-84. doi: 10.1111/tbj.12164. Epub 2013 Jul 19.</citation>
    <PMID>23865902</PMID>
  </reference>
  <reference>
    <citation>Weber WP, Tausch C, Hayoz S, Fehr MK, Ribi K, Hawle H, Lupatsch JE, Matter-Walstra K, Chiesa F, Dedes KJ, Berclaz G, Lelievre L, Hess T, Guth U, Pioch V, Sarlos D, Leo C, Canonica C, Gabriel N, Zeindler J, Cassoly E, Andrieu C, Soysal SD, Ruhstaller T, Fehr PM, Knauer M; Swiss Group for Clinical Cancer Research (SAKK). Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial. Ann Surg Oncol. 2018 Sep;25(9):2632-2640. doi: 10.1245/s10434-018-6556-9. Epub 2018 Jun 8.</citation>
    <PMID>29948418</PMID>
  </reference>
  <reference>
    <citation>He XD, Guo ZH, Tian JH, Yang KH, Xie XD. Whether drainage should be used after surgery for breast cancer? A systematic review of randomized controlled trials. Med Oncol. 2011 Dec;28 Suppl 1:S22-30. doi: 10.1007/s12032-010-9673-2. Epub 2010 Sep 9.</citation>
    <PMID>20827578</PMID>
  </reference>
  <reference>
    <citation>Thomson DR, Sadideen H, Furniss D. Wound drainage after axillary dissection for carcinoma of the breast. Cochrane Database Syst Rev. 2013 Oct 20;2013(10):CD006823. doi: 10.1002/14651858.CD006823.pub2.</citation>
    <PMID>24158902</PMID>
  </reference>
  <reference>
    <citation>Petrek JA, Blackwood MM. Axillary dissection: current practice and technique. Curr Probl Surg. 1995 Apr;32(4):257-323. doi: 10.1016/s0011-3840(05)80015-2. No abstract available.</citation>
    <PMID>7705102</PMID>
  </reference>
  <reference>
    <citation>Kuroi K, Shimozuma K, Taguchi T, Imai H, Yamashiro H, Ohsumi S, Saito S. Pathophysiology of seroma in breast cancer. Breast Cancer. 2005;12(4):288-93. doi: 10.2325/jbcs.12.288.</citation>
    <PMID>16286909</PMID>
  </reference>
  <reference>
    <citation>Bonnema J, Ligtenstein DA, Wiggers T, van Geel AN. The composition of serous fluid after axillary dissection. Eur J Surg. 1999 Jan;165(1):9-13. doi: 10.1080/110241599750007441.</citation>
    <PMID>10069628</PMID>
  </reference>
  <reference>
    <citation>McCaul JA, Aslaam A, Spooner RJ, Louden I, Cavanagh T, Purushotham AD. Aetiology of seroma formation in patients undergoing surgery for breast cancer. Breast. 2000 Jun;9(3):144-8. doi: 10.1054/brst.1999.0126.</citation>
    <PMID>14731838</PMID>
  </reference>
  <reference>
    <citation>Lotze MT, Duncan MA, Gerber LH, Woltering EA, Rosenberg SA. Early versus delayed shoulder motion following axillary dissection: a randomized prospective study. Ann Surg. 1981 Mar;193(3):288-95. doi: 10.1097/00000658-198103000-00007.</citation>
    <PMID>7011221</PMID>
  </reference>
  <reference>
    <citation>Pinero-Madrona A, Castellanos-Escrig G, Abrisqueta-Carrion J, Canteras-Jordana M. Prospective randomized controlled study to assess the value of a hemostatic and sealing agent for preventing seroma after axillary lymphadenectomy. J Surg Oncol. 2016 Sep;114(4):423-7. doi: 10.1002/jso.24344. Epub 2016 Jun 23.</citation>
    <PMID>27338717</PMID>
  </reference>
  <reference>
    <citation>Conversano A, Mazouni C, Thomin A, Gaudin A, Fournier M, Rimareix F, Bonastre J. Use of Low-Thrombin Fibrin Sealant Glue After Axillary Lymphadenectomy for Breast Cancer to Reduce Hospital Length and Seroma. Clin Breast Cancer. 2017 Jul;17(4):293-297. doi: 10.1016/j.clbc.2016.12.013. Epub 2017 Jan 10.</citation>
    <PMID>28161131</PMID>
  </reference>
  <reference>
    <citation>Vasileiadou K, Kosmidis C, Anthimidis G, Miliaras S, Kostopoulos I, Fahantidis E. Cyanoacrylate Adhesive Reduces Seroma Production After Modified Radical Mastectomy or Quadrantectomy With Lymph Node Dissection-A Prospective Randomized Clinical Trial. Clin Breast Cancer. 2017 Dec;17(8):595-600. doi: 10.1016/j.clbc.2017.04.004. Epub 2017 Apr 13.</citation>
    <PMID>28673765</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>February 16, 2023</last_update_submitted>
  <last_update_submitted_qc>February 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación para la Investigación del Hospital Clínico de Valencia</investigator_affiliation>
    <investigator_full_name>Elvira Buch</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>aspirative drainage</keyword>
  <keyword>hemopatch</keyword>
  <keyword>seroma</keyword>
  <keyword>breast cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT04487561
org study id: REDHEMOPACH
nct id: NCT04487561
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aspirative drainage continues to be the "gold standard" for the management of this
      post-surgical complication, even though it can lead to complications such as obstruction of
      the drainage, peritubal leakage of the seroma, etc. This may result in pain and reduction in
      mobility of the affected arm.

      Based on our positive clinical outcomes and the fact that there is not any published data
      available in the literature regarding this use of the patch, the investigators propose a
      multicentric, randomized controlled clinical trial, with the objective of comparing the
      Hemopatch® with the usual technique used (aspirative drainage) in terms of efficacy and
      safety.

      Hypothesis: Placing a Hemopatch ® instead of an aspirative drainage in women after undergoing
      axillary lymph node dissection during breast cancer surgery may reduce the appearance of
      seroma and consequently the need for a puncture, as well as the complications related to
      aspirative drainage.
1. Introduction:

           In the surgical management of breast cancer, a conservative approach is the "gold
           standard" for the mammary region. For the axillary region, however, this depends on the
           results of the sentinel lymph node biopsy (SLNB) with axillary lymph node dissection
           (ALND) continuing to be an indispensable procedure when the disease reaches this level.

           The complications that arise from this procedure can be divided in two groups: 1) early:
           seromas and nerve lesions and 2) late: lymphedema, functional disorders in shoulder
           movement and post-mastectomy pain syndrome.

           Seromas are the most frequent complications after an ALND. In themselves, they do not
           carry a high risk of morbidity. However, they delay healing of the surgical wound,
           increasing the risk of infection and number of ambulatory visits and furthermore,
           resulting in a deferral in the start of adjuvant therapies such as radio and
           chemotherapy.

           Aspirative drainage continues to be the "gold standard" for the management of this
           post-surgical complication, even though it can lead to complications such as obstruction
           of the drainage, peritubal leakage of the seroma, etc. This may result in pain and
           reduction in mobility of the affected arm.

           Hemopatch® is a hemosthatic sealer made from reabsorbable collagen. It comes in the from
           of patch, with CE marking that is already being used in the clinical setting in Spain
           and the rest of Europe.

           Taking into account the factors that reduce seroma formation after ALND and the
           characteristics of the patch, its application after surgery could be useful in
           preventing seroma formation. More specifically, the patch has proven to act as a

             -  Hemosthatic, improving the first phase of inflammation

             -  Adhesive, reducing the dead space left after ALND

             -  Sealer, decreasing the exudate

        2. Rationale Based on this premise and in the context of a clinical protocol after the
           introduction of the patch in daily clinical practice, it was used on 28 patients that
           underwent ALND, obtaining favourable clinical results. This is a multicentric,
           randomized controlled clinical trial, with the objective of comparing the Hemopatch®
           with the usual technique used (aspirative drainage) in terms of efficacy and safety.

        3. Hypothesis Placing a Hemopatch ® instead of an aspirative drainage in women after
           undergoing ALND during breast cancer surgery may reduce the appearance of seroma and
           consequently the need for a puncture, as well as the complications related to aspirative
           drainage.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective multicentric randomized controlled clinical trial
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: To develop seroma after surgery
time frame: Percentage, through study completion, an average of 2 months
description: Percentage of patients that receive Hemopatch® that develop seroma after surgery and percentage of patients that receive that develop seroma after extraction of the aspirative drainage.
measure: total volumen of the seroma
time frame: from 24 hours until there is no seroma, assessed up to 2 months
description: The initial control will be performed 24 hours after the intervention, maintaining AD if the volume is greater than 30ml. All patients will be seen 7 days after surgery. The follow-up time will be weekly until there is no seroma, measuring the volume of the seroma extracted by puncture,
measure: Seroma punctures
time frame: through study completion, an average of 2 months
description: the total number of punctures needed
measure: complications
time frame: from 24 hours until there is no complications, assessed up to 2 months
description: Other complications collected throughout the study include: bruising (yes / no), pain (yes / no), problems with aspiration drainage (yes / no)
measure: quality of life in patients
time frame: 1 week after surgery with Eortc QLQ-BR23
description: Compare the quality of life in patients after receiving either of these procedures using the Eortc QLQ-BR23 survey
measure: the costs
time frame: through study completion, an average of 1 year
description: Compare the costs of both procedures by quantifying the costs of materials and consult time used in both procedures
measure: body mass index
time frame: weight (kg) / height (m2). In the first consultation
description: body mass index
arm group label: aspirative drainage
arm group type: Other
description: Drainage is the usual treatment after axillary lymphadenectoma for breast cancer
arm group label: Hemopatch
arm group type: Active Comparator
description: The hemopatch group will be the group without drainage and with a product patch
intervention type: Device
intervention name: hemopatch
description: The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma
arm group label: Hemopatch
intervention type: Procedure
intervention name: Aspirative drainage
description: The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma
arm group label: aspirative drainage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
country: Spain
url: http://www.eortc.org
description: Survey of Eortc QLQ- BR23
url: http://www.ncbi.nlm.nih.gov/pubmed/16286909
description: Pathophysiology of seroma in breast cancer. Breast Cancer [Internet]. 2005;12(4):288-93.
citation: Lewis KM, Ikeme S, Olubunmi T, Kuntze CE. Clinical effectiveness and versatility of a sealing hemostatic patch (HEMOPATCH) in multiple surgical specialties. Expert Rev Med Devices. 2018 May;15(5):367-376. doi: 10.1080/17434440.2018.1464909. Epub 2018 Apr 26.
PMID: 29658322
citation: Droeser RA, Frey DM, Oertli D, Kopelman D, Baas-Vrancken Peeters MJ, Giuliano AE, Dalberg K, Kallam R, Nordmann A. Volume-controlled vs no/short-term drainage after axillary lymph node dissection in breast cancer surgery: a meta-analysis. Breast. 2009 Apr;18(2):109-14. doi: 10.1016/j.breast.2009.02.003. Epub 2009 Mar 16.
PMID: 19289285
citation: Aitken DR, Minton JP. Complications associated with mastectomy. Surg Clin North Am. 1983 Dec;63(6):1331-52. doi: 10.1016/s0039-6109(16)43192-0. No abstract available.
PMID: 6359504
citation: Kottayasamy Seenivasagam R, Gupta V, Singh G. Prevention of seroma formation after axillary dissection--a comparative randomized clinical trial of three methods. Breast J. 2013 Sep-Oct;19(5):478-84. doi: 10.1111/tbj.12164. Epub 2013 Jul 19.
PMID: 23865902
citation: Weber WP, Tausch C, Hayoz S, Fehr MK, Ribi K, Hawle H, Lupatsch JE, Matter-Walstra K, Chiesa F, Dedes KJ, Berclaz G, Lelievre L, Hess T, Guth U, Pioch V, Sarlos D, Leo C, Canonica C, Gabriel N, Zeindler J, Cassoly E, Andrieu C, Soysal SD, Ruhstaller T, Fehr PM, Knauer M; Swiss Group for Clinical Cancer Research (SAKK). Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial. Ann Surg Oncol. 2018 Sep;25(9):2632-2640. doi: 10.1245/s10434-018-6556-9. Epub 2018 Jun 8.
PMID: 29948418
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responsible party type: Principal Investigator
investigator affiliation: Fundación para la Investigación del Hospital Clínico de Valencia
investigator full name: Elvira Buch
investigator title: Principal Investigator
mesh term: Breast Neoplasms
sharing ipd: No