Impact of a Surgical Sealing Patch on Lymphatic Drainage After ALND for Breast Cancer
Status:
Completed
Trial end date:
2017-06-27
Target enrollment:
Participant gender:
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.