Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain
ConditionSeroma Following Procedure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOmphis Foundation
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years old
Conservative surgery for breast cancer with associated axillary lymphadenectomy
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Glubran 2
Other interventionApplication of Glubran 2 sealant (liquid) in axillary hollow
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: lymphadenectomy without drainage and with GlubranExperimental treatment 1 intervention
Group B: Lymphadenectomy without drainageNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in symptomatic seroma
Number of evacuating punctures
Time frame
Up tp 1 year2
Number of participants with treatment-related adverse events
Type and number of adverse events
Time frame
Up to 1 yearSecondary outcomes
1
Seroma volume
Volume measured by ultrasound (cm3 )
Time frame
Day 7 and 14 after surgery2
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 surgery3
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 year4
Number of patients with temporary or permanence of disability after operation
Clavien-Dindo classification of morbidity
Time frame
Up to 1 yearSponsors and contacts
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Omphis Foundation
Lead sponsor
Consorci Sanitari del Maresme
Collaborator
Source ClinicalTrials.gov