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Hemopatch Implication After Axillary Dissection for Breast Cancer

NCT ID: NCT06744998

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2026-03-31

Brief Summary

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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

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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

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Breast Cancer

Keywords

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Primary breast cancer Axillary dissection Axillary seroma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective monocentric controlled randomized surgical trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Hemopatch® group

Hemopatch® application after axillary dissection

Group Type EXPERIMENTAL

Hemopatch® (Baxter)

Intervention Type DEVICE

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

No Hemopatch® group

No Hemopatch® application after axillary dissection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hemopatch® (Baxter)

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Giovanni Corso, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

European Istitute of Oncology

Locations

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European Institute of Oncology

Milan, , Italy

Site Status

Countries

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Italy

Central Contacts

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Giovanni Corso, MD, PhD

Role: CONTACT

Phone: +39 0294375161

Email: [email protected]

Mara Negri

Role: CONTACT

Phone: +39 0257489536

Email: [email protected]

Facility Contacts

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Giovanni Corso, MD, PhD

Role: primary

Other Identifiers

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L2-249

Identifier Type: -

Identifier Source: org_study_id