Clinical trial NCT05280353: Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain
Official title: Seroma Control in Axillary Lymphadenectomy With Glubran 2® Without Drain. Multicenter, Prospective, Randomized Clinical Trial. GALA-ND Study (Glu Axillary Lymphadenectomy Ambulatory- no Drain)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Seroma Following Procedure
Lead sponsor: Omphis Foundation
Sponsor class: OTHER
Collaborators: name: Consorci Sanitari del Maresme
First posted: 2022-03-15
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: MULTICENTRIC, PROSPECTIVE, RANDOMIZED CLINICAL TRIAL
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in symptomatic seroma
timeFrame: Up tp 1 year
measure: Number of participants with treatment-related adverse events
timeFrame: Up to 1 year
Secondary outcomes:
measure: Seroma volume
timeFrame: Day 7 and 14 after surgery
measure: Milliliters of evacuated seroma in case of puncture
timeFrame: 7, 14 and 30 day after surgery
measure: Demographic characteristics of patients related to seroma
timeFrame: Up to 1 year
measure: Number of patients with temporary or permanence of disability after operation
timeFrame: Up to 1 year
measure: Individual's perception of the position in life of the participants
timeFrame: Day 7 and 14 after surgery
Other outcomes:
Locations:
city: Mataró
country: Spain
facility: Maresme health consortium
Study officials:
affiliation: Health Consortium Maresme
name: Sandra Lopez Gordo, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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