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

• Status: Completed
• Trial end date: 2017-06-27
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research

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