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Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Several studies and a meta-analysis showed that fibrin sealant patches reduced lymphatic drainage after various lymphadenectomy procedures. Our goal was to investigate the impact of these patches on drainage after axillary dissection for breast cancer.

Methods

In a phase III superiority trial, we randomized patients undergoing breast-conserving surgery at 14 Swiss sites to receive versus not receive three large TachoSil® patches in the dissected axilla. Axillary drains were inserted in all patients. Patients and investigators assessing outcomes were blinded to group assignment. The primary endpoint was total volume of drainage.

Results

Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil® and 70 without). Mean total volume of drainage in the control group was 703 ml [95% confidence interval (CI) 512–895 ml]. Application of TachoSil® did not significantly reduce the total volume of axillary drainage [mean difference (MD) −110 ml, 95% CI −316 to 94, p = 0.30]. A total of eight secondary endpoints related to drainage, morbidity, and quality of life were not improved by use of TachoSil®. The mean total cost per patient did not differ significantly between the groups [34,253 Swiss Francs (95% CI 32,625–35,880) with TachoSil® and 33,365 Swiss Francs (95% CI 31,771–34,961) without, p = 0.584]. In the TachoSil® group, length of stay was longer (MD 1 day, 95% CI 0.3–1.7, p = 0.009), and improvement of pain was faster, although the latter difference was not significant [2 days (95% CI 1–4) vs. 5.5 days (95% CI 2–11); p = 0.2].

Conclusions

TachoSil® reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.

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Acknowledgment

The authors thank Andreas Gyr for his assistance in writing the manuscript and Daniele Oberti for his assistance in coordinating the study. Funding received for this work from the Swiss Cancer League, the Swiss Secretariat for Education, Research and Innovation (SERI), and Takeda Pharmaceuticals International AG.

Author information

Authors and Affiliations

  1. Breast Center, University Hospital Basel, University of Basel, Basel, Switzerland

    Walter Paul Weber MD, Jasmin Zeindler MD & Savas Deniz Soysal MD

  2. Breast Center Zürich, Zurich, Switzerland

    Christoph Tausch MD, Federica Chiesa MD & Uwe Güth MD

  3. SAKK Coordinating Center, Bern, Switzerland

    Stefanie Hayoz PhD, Karin Ribi PhD, Hanne Hawle MD, Estelle Cassoly PhD & Christiane Andrieu PhD

  4. Cantonal Hospital Frauenfeld, Frauenfeld, Switzerland

    Mathias Konrad Fehr MD

  5. IBCSG Coordinating Center, Bern, Switzerland

    Karin Ribi PhD

  6. Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland

    Judith Eva Lupatsch PhD & Klazien Matter-Walstra PhD

  7. Breast Center St. Gallen, Cantonal Hospital St. Gallen, St. Gallen, Switzerland

    Federica Chiesa MD, Thomas Ruhstaller MD & Michael Knauer MD, PhD

  8. Breast Cancer Center, Comprehensive Cancer Center Zurich, University Hospital of Zurich, Zurich, Switzerland

    Konstantin Johannes Dedes MD

  9. Breast Center Bern Lindenhofgruppe, Bern, Switzerland

    Gilles Berclaz MD

  10. Centre du sein, Centre Hospitalier Universitaire Vaudois - CHUV, Lausanne, Switzerland

    Loic Lelièvre MD

  11. Cantonal Hospital Winterthur, Winterthur, Switzerland

    Thomas Hess MD & Uwe Güth MD

  12. ZeTuP St. Gallen, St. Gallen, Switzerland

    Verena Pioch MD

  13. Cantonal Hospital Aarau, Aarau, Switzerland

    Dimitri Sarlos MD

  14. Cantonal Hospital Baden, Baden, Switzerland

    Cornelia Leo MD

  15. IOSI Bellinzona, Bellinzona, Switzerland

    Claudia Canonica MD

  16. City Hospital Triemli, Zurich, Switzerland

    Natalie Gabriel MD

  17. Breast Center Graubünden, Cantonal Hospital Graubünden, Chur, Switzerland

    Peter Martin Fehr MD

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  1. Walter Paul Weber MD
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  2. Christoph Tausch MD
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  9. Federica Chiesa MD
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  23. Savas Deniz Soysal MD
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for the Swiss Group for Clinical Cancer Research (SAKK)

Corresponding author

Correspondence to Walter Paul Weber MD.

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Weber, W.P., Tausch, C., Hayoz, S. et al. 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 25, 2632–2640 (2018). https://doi.org/10.1245/s10434-018-6556-9

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  • DOI: https://doi.org/10.1245/s10434-018-6556-9

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