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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- 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
- 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
- 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.
- Patients with clinically relevant seroma [ Time Frame: until 24 weeks after surgery ]Clinically relevant seroma is defined as either causing discomfort or requiring aspiration.
- Number of clinically relevant seroma aspirations [ Time Frame: until 24 weeks after surgery ]Number of clinically relevant seroma aspirations until 24 weeks after surgery
- 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
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
|Aarau, Switzerland, 5001|
|Baden, Switzerland, 5404|
|Basel, Switzerland, 4031|
|CSSI Bellinzona/Lugano, Ospedale San Giovanni|
|Bellinzona, Switzerland, 6500|
|Brustzentrum, Klinik Engeried|
|Bern, Switzerland, 3012|
|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|
|Zürich, Switzerland, 8008|
|Zürich, Switzerland, 8063|
|UniversitätsSpital Zürich, Klinik für Gynäkologie|
|Zürich, Switzerland, 8091|
|Study Chair:||Walter Weber, MD||University of Basel|
|Study Chair:||Christoph Tausch, MD||Klinik Hirslanden, Zürich|