Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy
Condition: Breast Cancer; Breast-conserving Surgery; Axillary Lymph Node Dissection
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): hemopatch; Aspirative drainage
Intervention type(s): Device; Procedure
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective multicentric randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: aspirative drainage; hemopatch; seroma; breast cancer