NCT06744998

Hemopatch Implication After Axillary Dissection for Breast Cancer

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Hemopatch® (Baxter)	HEMOPATCH® is an absorbable collagen pad intended for sealing and hemostasis

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2024-12-20
• Last updated: 2024-12-20

Locations

1 site across 1 country: Italy