Status:

RECRUITING

Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

Lead Sponsor:

Omphis Foundation

Collaborating Sponsors:

Consorci Sanitari del Maresme

Conditions:

Seroma Following Procedure

Eligibility:

FEMALE

18+ years

Phase:

NA

Brief Summary

Axillary lymphadenectomy in breast cancer continues to be a common practice in certain patients. The use of sealants and drains continues to be a source of disagreement among the scientific community....

Detailed Description

A study has been designed to assess whether the sealant reduces the rate of symptomatic seroma measured by the number of evacuating punctures. Likewise, the decrease in volume due to the seroma betwee...

Eligibility Criteria

Inclusion

  • Over 18 years old
  • Conservative surgery for breast cancer with associated axillary lymphadenectomy

Exclusion

  • Mastectomy
  • History of axillary surgery or ipsilateral axillary radiotherapy
  • ASA 4 patients. (ASA 3 patients selected)
  • Lack of adequate cognitive capacity and/or signed informed consent
  • Pregnancy

Key Trial Info

Start Date :

April 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

134 Patients enrolled

Trial Details

Trial ID

NCT05280353

Start Date

April 1 2022

End Date

June 1 2026

Last Update

September 4 2024

Active Locations (1)

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Maresme health consortium

Mataró, Spain