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Drainage is the usual treatment after axillary lymphadenectoma for breast cancer

The hemopatch group will be the group without drainage and with a product patch

The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma

hemopatch

Aspirative drainage

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.

Prospective multicentric randomized controlled clinical trial

Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy

Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy: Randomized, Controlled, Multicenter Clinical Study

Percentage of patients that receive Hemopatch® that develop seroma after surgery and percentage of patients that receive that develop seroma after extraction of the aspirative drainage.

The initial control will be performed 24 hours after the intervention, maintaining AD if the volume is greater than 30ml. All patients will be seen 7 days after surgery. The follow-up time will be weekly until there is no seroma, measuring the volume of the seroma extracted by puncture,

Other complications collected throughout the study include: bruising (yes / no), pain (yes / no), problems with aspiration drainage (yes / no)

Compare the quality of life in patients after receiving either of these procedures using the Eortc QLQ-BR23 survey

Compare the costs of both procedures by quantifying the costs of materials and consult time used in both procedures

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy	NCT04487561	Breast Cancer Breast-conservi... Axillary Lymph ...	hemopatch Aspirative drai...	18 Years - 99 Years	Fundación para la Investigación del Hospital Clínico de Valencia
Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy	NCT04487561	Breast Cancer Breast-conservi... Axillary Lymph ...	hemopatch Aspirative drai...	18 Years - 99 Years	Fundación para la Investigación del Hospital Clínico de Valencia

Spots Global Cancer Trial Database for aspirative drainage