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Hemopatch Implication After Axillary Dissection for Breast Cancer

Hemopatch Implication After Axillary Dissection for Breast Cancer: a Randomized Clinical Study

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06744998
Acronym
BreastPatch
Enrollment
190
Registered
2024-12-20
Start date
2025-02-28
Completion date
2026-03-31
Last updated
2024-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Primary breast cancer, Axillary dissection, Axillary seroma

Brief summary

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.

Detailed 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.

Interventions

DEVICEHemopatch® (Baxter)

HEMOPATCH® is an absorbable collagen pad intended for sealing and hemostasis

Sponsors

European Institute of Oncology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Prospective monocentric controlled randomized surgical trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Axillary seroma evaluation1 weekMeasure of drain output (in cc) in one week

Secondary

MeasureTime frameDescription
Hospital access evaluation1 monthTotal number of hospital accesses per patient within one month post-surgery
Drain duration evaluation1 monthTime until drain removal (in days)

Countries

Italy

Contacts

Primary ContactGiovanni Corso, MD, PhD
giovanni.corso@ieo.it+39 0294375161
Backup ContactMara Negri
mara.negri@ieo.it+39 0257489536

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026