Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

Omphis Foundation134 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

134

Conditions

Seroma Following Procedure

Interventions

Glubran 2OTHER

Application of Glubran 2 sealant (liquid) in axillary hollow

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Maresme health consortium

Mataró, Spain

RECRUITING

Outcomes

Primary Outcomes

Change in symptomatic seroma

Number of evacuating punctures

Time frame: Up tp 1 year

Number of participants with treatment-related adverse events

Type and number of adverse events

Time frame: Up to 1 year

Secondary Outcomes

Seroma volume

Volume measured by ultrasound (cm3 )

Time frame: 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

Time frame: 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

Time frame: Up to 1 year

Number of patients with temporary or permanence of disability after operation

Clavien-Dindo classification of morbidity

Time frame: 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

Time frame: Day 7 and 14 after surgery

Central Contacts

Sandra Lopez Gordo

CONTACT

937 41 77 00 slopezgord@csdm.cat

Data from ClinicalTrials.gov

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