Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy
Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy
Aspirative drainage continues to be the "gold standard" for the management of this
 post-surgical complication, even though it can lead to complications such as obstruction of
 the drainage, peritubal leakage of the seroma, etc. This may result in pain and reduction in
 mobility of the affected arm.

 Based on our positive clinical outcomes and the fact that there is not any published data
 available in the literature regarding this use of the patch, the investigators propose a
 multicentric, randomized controlled clinical trial, with the objective of comparing the
 Hemopatch® with the usual technique used (aspirative drainage) in terms of efficacy and
 safety.

 Hypothesis: Placing a Hemopatch ® instead of an aspirative drainage in women after undergoing
 axillary lymph node dissection during breast cancer surgery may reduce the appearance of
 seroma and consequently the need for a puncture, as well as the complications related to
 aspirative drainage.
1. Introduction:

 In the surgical management of breast cancer, a conservative approach is the "gold
 standard" for the mammary region. For the axillary region, however, this depends on the
 results of the sentinel lymph node biopsy (SLNB) with axillary lymph node dissection
 (ALND) continuing to be an indispensable procedure when the disease reaches this level.

 The complications that arise from this procedure can be divided in two groups: 1) early:
 seromas and nerve lesions and 2) late: lymphedema, functional disorders in shoulder
 movement and post-mastectomy pain syndrome.

 Seromas are the most frequent complications after an ALND. In themselves, they do not
 carry a high risk of morbidity. However, they delay healing of the surgical wound,
 increasing the risk of infection and number of ambulatory visits and furthermore,
 resulting in a deferral in the start of adjuvant therapies such as radio and
 chemotherapy.

 Aspirative drainage continues to be the "gold standard" for the management of this
 post-surgical complication, even though it can lead to complications such as obstruction
 of the drainage, peritubal leakage of the seroma, etc. This may result in pain and
 reduction in mobility of the affected arm.

 Hemopatch® is a hemosthatic sealer made from reabsorbable collagen. It comes in the from
 of patch, with CE marking that is already being used in the clinical setting in Spain
 and the rest of Europe.

 Taking into account the factors that reduce seroma formation after ALND and the
 characteristics of the patch, its application after surgery could be useful in
 preventing seroma formation. More specifically, the patch has proven to act as a

 -  Hemosthatic, improving the first phase of inflammation

 -  Adhesive, reducing the dead space left after ALND

 -  Sealer, decreasing the exudate

 2. Rationale Based on this premise and in the context of a clinical protocol after the
 introduction of the patch in daily clinical practice, it was used on 28 patients that
 underwent ALND, obtaining favourable clinical results. This is a multicentric,
 randomized controlled clinical trial, with the objective of comparing the Hemopatch®
 with the usual technique used (aspirative drainage) in terms of efficacy and safety.

 3. Hypothesis Placing a Hemopatch ® instead of an aspirative drainage in women after
 undergoing ALND during breast cancer surgery may reduce the appearance of seroma and
 consequently the need for a puncture, as well as the complications related to aspirative
 drainage.
Inclusion Criteria:

 -  Diagnosis of breast cancer,

 -  scheduled for surgical treatment including conservative surgery and ALND.

 -  Signed informed consent for ALND.

 Exclusion Criteria:

 -  Selective sentinel node biopsy negative.

 -  Subsidiary mastectomy patients.

 -  Denial of informed consent for axillary lymphadenectomy.