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5 results for “Axillary seroma”
Cyanoacrylate glue in breast surgery: the GLUBREAST Trial Can cyanoacrylate glue reduce seroma after axillary dissection?
<p>In 2018, the National Cancer Institute of Naples has launched the GLUBREAST Trial to verify the efficacy of cyanoacrylate sealing glue to reduce seroma after axillary dissection in breast surgery. The glue is a synthetic sealant, 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. Methods The trial included one hundred-eighty patients scheduled for breast conserving surgery or total mastectomy without reconstruction.Ninety-one 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<br>mastectomy (β 2.5; 95% CI: ‐3.6‐8.6). We did not find statistically significant differences in presence of liquid drained and volume<br>drained among the study groups. An advantage for the Experimental Arm was observed from 3 th and 4 th to 5 th outpatient<br>visits without reaching a statistical significance (p=0.069 and p=0.072, respectively), so far 5% of patients in the Experimental<br>Group had clinical benefit from the glue.Conclusions. Data in the literature come from case series, and surgeons need higher level<br>of evidence to drive surgical decision-making and choose proper devices to increase patient quality of life. GLUBREAST randomized trial tested the efficacy of cyanoacrylate sealing glue to prevent post-operative 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.</p>
Effectivenes of Cyanoacrylate (Glubran 2®) in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection
ClinicalTrials.gov study NCT02141373. IPD Sharing: Not stated. Countries: 1. Publications: 1.
Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure
ClinicalTrials.gov study NCT01731769. IPD Sharing: Not stated. Countries: 1. Publications: 0.
Evaluating Hemopatch in Reducing Seroma Related Complications Following Axillary Lymph Node Dissection: a Pilot Study
ClinicalTrials.gov study NCT04185480. IPD Sharing: NO. Countries: 1. Publications: 0.
Contrast The Role of Avitene And OK-432 in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer
ClinicalTrials.gov study NCT02158299. IPD Sharing: Not stated. Countries: 1. Publications: 0.
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