Hemopatch Implication After Axillary Dissection for Breast Cancer

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06744998
• Lead Sponsor: European Institute of Oncology

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Start: 2025-02
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axillary seroma evaluation	1 week	Measure of drain output (in cc) in one week

Secondary Outcome Measures

Name	Time	Method
Hospital access evaluation	1 month	Total number of hospital accesses per patient within one month post-surgery
Drain duration evaluation	1 month	Time until drain removal (in days)

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy