Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain (GALA)

Omphis Foundation

Status: Enrolling

Conditions: Seroma Following Procedure

Treatments: Other: Glubran 2

Study type: Interventional

Funder types: Other

Identifiers

NCT05280353

Health consortium maresme

Details and patient eligibility

About

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.

Full 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 between the two groups and the quality of life of the patients is assessed, given that none of them has a drain

Enrollment: 134 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

lymphadenectomy without drainage and with Glubran

Experimental group

Description:

Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain

Treatment:

Other: Glubran 2

Lymphadenectomy without drainage

No Intervention group

Description:

No intervention required, only axillary dissection without drain