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Impact of a Surgical Sealing Patch on Lymphatic Drainage After ALND for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02311543
Recruitment Status : Completed
First Posted : December 8, 2014
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research

Brief Summary:

Axillary lymph node dissection remains an integral part of surgical treatment of primarily node-positive invasive breast cancer. In order to reduce the incidence of clinically relevant seroma, a suction drain is routinely placed into the axillary cavity after axillary lymph node dissection (ALND) by a separate stab incision. The pathogenesis of seroma involves the collection of lymph fluid caused by dissection of lymph vessels and exudate. All coagulation and fibrinolytic factors are produced and secreted by lymphatic endothelial cells and are involved in the sealing of lymphatic capillaries. Local hemostyptic agents may therefore reduce postoperative secretion from lymphatic fistulas caused by ALND.

We propose to conduct a multicenter prospective randomized control trial in Switzerland to evaluate the impact of TachoSil®, a ready-to-use, absorbable surgical patch (consisting of an equine collagen sponge coated with human fibrinogen and human thrombin) on axillary drainage after ALND for breast cancer. We hypothesize that the use of TachoSil® significantly and relevantly reduces the volume and duration of axillary drainage after ALND. This has the potential to increase patients' quality of life, as well as to shorten the length of hospital stay and reduce hospital costs.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: TachoSil® patches Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Lymph Node Dissection for Breast Cancer. A Multicenter Randomized Phase III Trial.
Actual Study Start Date : March 18, 2015
Actual Primary Completion Date : May 23, 2017
Actual Study Completion Date : June 27, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: TachoSil

Arm Intervention/treatment
No Intervention: Arm A: no TachoSil®
After axillary lymph node dissection no surgical sealing patch (TachoSil®) is applied.
Active Comparator: Arm B: TachoSil®
After axillary lymph node dissection, 3 large TachoSil® patches in the dissected axilla are positioned to cover as much of the axillary walls as possible.
Drug: TachoSil® patches
TachoSil® is a sterile, ready-to-use, absorbable surgical patch and consists of an equine collagen sponge coated with human fibrinogen and human thrombin.




Primary Outcome Measures :
  1. Total volume of axillary drainage [ Time Frame: until drain removal (2 - 10 days after surgery) ]
    Total volume of axillary drainage in ml until drain removal.


Secondary Outcome Measures :
  1. Volume of axillary drainage per 24 hours [ Time Frame: until drain removal (2 - 10 days after surgery) ]
    Volume of axillary drainage per 24 hours in ml will be calculated as the total volume of axillary drainage in ml until drain removal divided by the total duration of axillary drainage in days

  2. Total duration of axillary drainage in days [ Time Frame: until drain removal (2 - 10 days after surgery) ]
    Total duration of axillary drainage in days will be calculated from the date of surgery to the date of axillary drain removal

  3. Duration of postoperative hospital stay in days [ Time Frame: between 3-6 days after surgery ]
    Duration of postoperative hospital stay in days will be calculated from the date of surgery to the date of hospital discharge.

  4. Patients with clinically relevant seroma [ Time Frame: until 24 weeks after surgery ]
    Clinically relevant seroma is defined as either causing discomfort or requiring aspiration.

  5. Number of clinically relevant seroma aspirations [ Time Frame: until 24 weeks after surgery ]
    Number of clinically relevant seroma aspirations until 24 weeks after surgery

  6. Total volume of all clinically relevant seroma aspirations in ml [ Time Frame: until 24 weeks after surgery ]
    Total volume of all clinically relevant seroma aspirations in ml until 24 weeks after surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

at registration

  • Patient has given written informed consent before registration
  • Female patients; eligible for primary ALND or sentinel lymph node procedure with frozen section and either:
  • newly diagnosed
  • or recurrent breast cancer in the conserved breast, chest wall or axilla
  • Patients with histo- or cytology proven breast cancer UICC/AJCC stage I-III
  • Age ≥ 18 years
  • Fluency in either German, French, Italian, Spanish, Turkish or English
  • The EQ-5D questionnaire has been completed at registration
  • Patient with child-bearing potential, willing to use effective contraception, not currently pregnant and agreeing not to become pregnant after trial registration and during the 24 weeks after surgery
  • A negative pregnancy test within 14 days prior to inclusion is available for all women with child-bearing potential

Inclusion criteria at randomization

- ALND indicated according to clinical standards, either as single procedure or in combination with breast conserving surgery

Exclusion Criteria at registration:

  • Known hypersensitivity for TachoSil® or fibrin sealant
  • Patients with mastectomy (simultaneously or within 1 month before registration); patients undergoing completion mastectomy at a later day will remain eligible and are evaluable for analysis according to intention to treat. If the axillary drain is still in place at the time of completion mastectomy and a separate drain is inserted underneath the skin flaps, only the axillary drain will be considered
  • Prior axillary dissection (except prior sentinel node procedure)
  • Prior axillary radiotherapy
  • Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent, filling out QoL forms
  • Concurrent treatment with other experimental drugs or treatment in a clinical trial within 30 days prior to trial entry

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311543


Locations
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Switzerland
Kantonsspital Aarau
Aarau, Switzerland, 5001
Kantonsspital Baden
Baden, Switzerland, 5404
Universitätsspital Basel
Basel, Switzerland, 4031
CSSI Bellinzona/Lugano, Ospedale San Giovanni
Bellinzona, Switzerland, 6500
Brustzentrum, Klinik Engeried
Bern, Switzerland, 3012
Kantonsspital Graubünden
Chur, Switzerland, 7000
Spital Thurgau AG, Brustzentrum
Frauenfeld, Switzerland, 8501
Hôpitaux universitaires de Genève
Genève 14, Switzerland, 1211
Centre Hospitalier Universitaire Vaudois CHUV
Lausanne, Switzerland, 1011
CHVC Hôpital de Sion
Sion, Switzerland, 1951
Tumor- und Brustzentrum ZeTuP St. Gallen
St. Gallen, Switzerland, 9006
Kantonsspital St. Gallen
St. Gallen, Switzerland, 9007
Kantonsspital Winterthur, Brustzentrum
Winterthur, Switzerland, 8401
Brust-Zentrum Seefeld
Zürich, Switzerland, 8008
Stadtspital Triemli
Zürich, Switzerland, 8063
UniversitätsSpital Zürich, Klinik für Gynäkologie
Zürich, Switzerland, 8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
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Study Chair: Walter Weber, MD University of Basel
Study Chair: Christoph Tausch, MD Klinik Hirslanden, Zürich
Publications of Results:
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Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT02311543    
Other Study ID Numbers: SAKK 23/13
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Swiss Group for Clinical Cancer Research:
Axillary Lymph Node Dissection (ALND)
Breast Cancer
TachoSil®
Lymphatic Drainage
Surgical Sealing Patch
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases