Clinical trial NCT04487561: Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy
Official title: Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy: Randomized, Controlled, Multicenter Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Breast-conserving Surgery
Axillary Lymph Node Dissection
Keywords: aspirative drainage
hemopatch
seroma
breast cancer
Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
Sponsor class: OTHER
First posted: 2020-07-27
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective multicentric randomized controlled clinical trial
Primary purpose: OTHER

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: 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.

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.

Primary outcomes:
measure: To develop seroma after surgery
timeFrame: Percentage, through study completion, an average of 2 months
measure: total volumen of the seroma
timeFrame: from 24 hours until there is no seroma, assessed up to 2 months
measure: Seroma punctures
timeFrame: through study completion, an average of 2 months
measure: complications
timeFrame: from 24 hours until there is no complications, assessed up to 2 months
Secondary outcomes:
measure: quality of life in patients
timeFrame: 1 week after surgery with Eortc QLQ-BR23
measure: the costs
timeFrame: through study completion, an average of 1 year
measure: body mass index
timeFrame: weight (kg) / height (m2). In the first consultation
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Clínico Universitario de Valencia
Study officials:
References:
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