Emanuela Esposito ^1* Claudio Siani ¹ Ivana Donzelli ¹ Anna Crispo ² Sergio Coluccia ² Piergiacomo Di Gennaro ² Assunta Luongo ² Franca Avino ¹ Alfredo Fucito ¹ Ugo Marone ¹ Maria Teresa Melucci ¹ Ruggero Saponara ¹ Raimondo di Giacomo ¹

• ¹ Department of Breast and Thoracic Oncology, G. Pascale National Cancer Institute Foundation (IRCCS), Naples, Italy
• ² Division of Epidemiology and Biostatistics, G. Pascale National Cancer Institute Foundation (IRCCS), Naples, Campania, Italy

In 2018, the National Cancer Institute of Naples has launched the GLUBREAST Trial to verify the efficacy of cyanoacrylate glue to reduce seroma after axillary dissection in breast surgery. The glue is a synthetic sealant (N-Butyl-2-CyanoAcrylate+Metacryloxisulfolane) biocompatible, CE approved for internal human uses and surgical procedures. The assumed mechanism of action in breast surgery is that the glue create a seal coating in the operative field to occlude lymphatic leaks and limit seroma formation. Materials and Methods The trial included one hundred-eighty patients scheduled for breast conserving surgery or radical modified mastectomy. Ninety-one patients were randomized to receive suction drain and sealant glue after axillary dissection (Experimental Arm), whereas eighty-nine patients (Control Arm) received suction drain without glue. Statistics A multivariable mixed effect model on presence of liquid drained and volume drained were calculated. Stratified models by visits were performed. Results The trial ended in June 2022. Older age was associated with a higher volume of seroma drained per day (β 0.30; 95% CI: 0.00-0.60). 5-U increase in Body Mass Index was associated with higher daily drained seroma volume in patients underwent breast conserving surgery (β 5.0; 95% CI: 0.62-9.4), but not in patients underwent mastectomy (β 2.5; 95% CI: -3.6-8.6). We did not find statistically significant differences in presence of liquid drained and volume drained among the study groups. An advantage for the Experimental Arm was observed from 3th and 4th to 5th outpatient visits without reaching a statistical significance (p=0.069 and p=0.072, respectively), so far 5% of patients in the Experimental Group had clinical benefit from the glue.The majority of data in the literature come from case series, thus surgeons need higher level of evidence to drive surgical decision-making and choose proper devices to increase patient quality of life. GLUBREAST trial tested the efficacy of cyanoacrylate sealing glue to prevent seroma in breast surgery. Although only a small number of patients benefited from sealant application, we regret to say this trial has some limitation, i.e. the prolonged presence of suction drain.Further research is warranted to better clarify the benefit of cyanoacrylate glue in breast surgery.