Hemopatch Implication After Axillary Dissection for Breast Cancer (BreastPatch)

December 17, 2024 updated by: European Institute of Oncology

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20141
        • European Institute of Oncology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemopatch® group
Hemopatch® application after axillary dissection
Device: Hemopatch® (Baxter)
HEMOPATCH® is an absorbable collagen pad intended for sealing and hemostasis
No Intervention: No Hemopatch® group
No Hemopatch® application after axillary dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Axillary seroma evaluation
Time Frame: 1 week
Measure of drain output (in cc) in one week
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital access evaluation
Time Frame: 1 month
Total number of hospital accesses per patient within one month post-surgery
1 month
Drain duration evaluation
Time Frame: 1 month
Time until drain removal (in days)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Giovanni Corso, MD, PhD, European Istitute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L2-249

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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