Hemopatch Implication After Axillary Dissection for Breast Cancer (BreastPatch)

European Institute of Oncology

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Device: Hemopatch® (Baxter)

Study type: Interventional

Funder types: Other

Identifiers

NCT06744998

L2-249

Details and patient eligibility

About

Aim of this randomized study is to assess the value of a different haemostatic sealant, the Hemopatch®, in axillary lymph node dissection (ALND) to reduce the incidence of seroma and seroma-related complications.

Full description

With the de-escalation of axillary lymph node dissection (ALND) to sentinel lymph node biopsy as a surgical procedure staging in breast cancer (BC), the physical and psychological morbidity has been improved significantly. However, ALND is still considered in a relevant number of BC patients as treatment for controlling locoregional axillary disease, and these patients present still important complications related to ALND, such as neuropathy, limitation of shoulder movement, arm lymphedema, and most commonly seroma evolution.

Multiple surgical devices with the intent to improve sealing of lymphatic and blood vessels have demonstrated contrasting results in the incidence of seroma formation after ALND and are no utilized routinary. Non-surgical devices, such as chemical medications, sealing small vessels by stimulating collagen and fibrinogen syntheses, also could improve to sealing of the lymphatic vessels. Additionally, fibrin glue-coated collagen patches and fibrin glue application to the surgical cavity were already tested in ALND patients with contrasting benefit in term of seroma prevention. Unfortunately, none of these studies provided a good solution to eliminate or reduce the incidence of seroma after ALND in BC treatment.

Aim of this randomized study is to assess the value of a different haemostatic sealant, the Hemopatch®, in axillary lymph node dissection (ALND) to reduce the incidence of seroma and seroma-related complications.

Enrollment: 190 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with primary breast cancer
• Mastectomy or breast conserving surgery
• Patients eligible for axillary dissection
• Male or female
• Any age
• Previous (or not) neoadjuvant treatments
• Any breast histotypes

Exclusion criteria

• Previous axillary surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Hemopatch® group

Experimental group

Description:

Hemopatch® application after axillary dissection

Treatment:

Device: Hemopatch® (Baxter)

No Hemopatch® group

No Intervention group

Description:

No Hemopatch® application after axillary dissection