Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy

Study Overview
=================
Brief 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
-----------------
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 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. 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.

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

Conditions
-----------------
Breast Cancer, Breast-conserving Surgery, Axillary Lymph Node Dissection

Intervention / Treatment
-----------------
* Device: hemopatch
* Procedure: Aspirative drainage


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective multicentric randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: aspirative drainage<br>Drainage is the usual treatment after axillary lymphadenectoma for breast cancer | Procedure: Aspirative drainage<br>* 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<br>|
| Active Comparator: Hemopatch<br>The hemopatch group will be the group without drainage and with a product patch | Device: hemopatch<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To develop seroma after surgery | 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. | Percentage, through study completion, an average of 2 months | 
| total volumen of the seroma | 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, | from 24 hours until there is no seroma, assessed up to 2 months | 
| Seroma punctures | the total number of punctures needed | through study completion, an average of 2 months | 
| complications | Other complications collected throughout the study include: bruising (yes / no), pain (yes / no), problems with aspiration drainage (yes / no) | from 24 hours until there is no complications, assessed up to 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life in patients | Compare the quality of life in patients after receiving either of these procedures using the Eortc QLQ-BR23 survey | 1 week after surgery with Eortc QLQ-BR23 | 
| the costs | Compare the costs of both procedures by quantifying the costs of materials and consult time used in both procedures | through study completion, an average of 1 year | 
| body mass index | body mass index | weight (kg) / height (m2). In the first consultation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aspirative drainage, hemopatch, seroma, breast cancer