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Completed

NCT Number: NCT04487561

Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy

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.

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Key information

Conditions

Breast Cancer Axillary Lymph Node Dissection Breast Diseases Breast Neoplasms Breast-conserving Surgery Inflammation Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Seroma Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HEMOPATCH

Device

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

Aspirative drainage

Procedure

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

Primary outcomes

  1. To develop seroma after surgery

    Time frame: Percentage, through study completion, an average of 2 months

    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.

  2. total volumen of the seroma

    Time frame: from 24 hours until there is no seroma, assessed up to 2 months

    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,

  3. Seroma punctures

    Time frame: through study completion, an average of 2 months

    the total number of punctures needed

  4. complications

    Time frame: from 24 hours until there is no complications, assessed up to 2 months

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

Secondary outcomes

  1. quality of life in patients

    Time frame: 1 week after surgery with Eortc QLQ-BR23

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

  2. the costs

    Time frame: through study completion, an average of 1 year

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

  3. body mass index

    Time frame: weight (kg) / height (m2). In the first consultation

    body mass index

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study title

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

Acronym: REDHEMOPACH

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 27, 2020
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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