Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    222
  • sponsor
    Fundación para la Investigación del Hospital Clínico de Valencia
Updated on 16 September 2021
cancer surgery
cancer
breast cancer
axillary lymph node dissection
seroma
lymph node dissection

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.

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.

Details
Condition axillary lymphadenectomy, Axillary Lymph Node Dissection, breast conserving surgery, cancer, breast, breast carcinoma, Breast Cancer, breast-conserving surgery, Mastectomy, Partial Mastectomy, axillary dissection, Breast Cancer Diagnosis
Treatment Hemopatch, Aspirative drainage
Clinical Study IdentifierNCT04487561
SponsorFundación para la Investigación del Hospital Clínico de Valencia
Last Modified on16 September 2021

Eligibility

Yes No Not Sure

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
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