RecruitingNot ApplicableNCT05280353

Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

Seroma Control in Axillary Lymphadenectomy With Glubran 2® Without Drain. Multicenter, Prospective, Randomized Clinical Trial. GALA-ND Study (Glu Axillary Lymphadenectomy Ambulatory- no Drain)


Sponsor

Omphis Foundation

Enrollment

134 participants

Start Date

Apr 1, 2022

Study Type

INTERVENTIONAL

Conditions

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. That is why the study was designed to show whether the sealant reduces seroma after axillary lymphadenectomy without drainage.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria2

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

Exclusion Criteria5

  • 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

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Interventions

OTHERGlubran 2

Application of Glubran 2 sealant (liquid) in axillary hollow


Locations(1)

Maresme health consortium

Mataró, Spain

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NCT05280353


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