NCT06744998

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 20, 2024

Status Verified

December 1, 2024

Enrollment Period

1.1 years

First QC Date

December 17, 2024

Last Update Submit

December 17, 2024

Conditions

Breast Cancer

Keywords

Primary breast cancerAxillary dissectionAxillary seroma

Outcome Measures

Primary Outcomes (1)

  • Axillary seroma evaluation

    Measure of drain output (in cc) in one week

    1 week

Secondary Outcomes (2)

  • Hospital access evaluation

    1 month

  • Drain duration evaluation

    1 month

Study Arms (2)

Hemopatch® group

EXPERIMENTAL

Hemopatch® application after axillary dissection

Device: Hemopatch® (Baxter)

No Hemopatch® group

NO INTERVENTION

No Hemopatch® application after axillary dissection

Interventions

Hemopatch® (Baxter)DEVICE

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

Hemopatch® group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previous axillary surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Giovanni Corso, MD, PhD

    European Istitute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Corso, MD, PhD

CONTACT

+39 0294375161giovanni.corso@ieo.it

Mara Negri

CONTACT

+39 0257489536mara.negri@ieo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Prospective monocentric controlled randomized surgical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

February 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

December 20, 2024

Record last verified: 2024-12

Locations

IT(1)