Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Seroma Following Procedure

Intervention / Treatment
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* Other: Glubran 2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: MULTICENTRIC, PROSPECTIVE, RANDOMIZED CLINICAL TRIAL
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lymphadenectomy without drainage and with Glubran<br>Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain | Other: Glubran 2<br>* Application of Glubran 2 sealant (liquid) in axillary hollow<br>|
| No Intervention: Lymphadenectomy without drainage<br>No intervention required, only axillary dissection without drain | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in symptomatic seroma | Number of evacuating punctures | Up tp 1 year | 
| Number of participants with treatment-related adverse events | Type and number of adverse events | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroma volume | Volume measured by ultrasound (cm3 ) | Day 7 and 14 after surgery | 
| Milliliters of evacuated seroma in case of puncture | Assess if there are differences in the volume of seroma evacuated (milliliters) between groups | 7, 14 and 30 day after surgery | 
| Demographic characteristics of patients related to seroma | Assess the existence of risk factors (age, sex, obesity,neoadjuvant treatment) related to symptomatic seroma | Up to 1 year | 
| Number of patients with temporary or permanence of disability after operation | Clavien-Dindo classification of morbidity | Up to 1 year | 
| Individual's perception of the position in life of the participants | Assess the quality of life after the intervention measured by the EuroQol five dimensions (EQ-5D-5L questionnaire). Descriptive system for health-related quality of life states in adults, consisting of five dimensions. No quality 0 points. Perfect quality 100 points | Day 7 and 14 after surgery |