Cargando…
Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial
BACKGROUND/PURPOSE: Seroma is a common complication after axillary dissection in women with node-positive breast cancer. We aim to determine the effect of Cyanoacrylate on reducing seroma formation in patients undergoing axillary dissection. This a randomized clinical trial. METHODS: This is a singl...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7868378/ https://www.ncbi.nlm.nih.gov/pubmed/33569343 http://dx.doi.org/10.3389/fonc.2020.580861 |
_version_ | 1783648438421815296 |
---|---|
author | Al-Masri, Mahmoud Alawneh, Fade Daoud, Faiez Ebous, Ali Hamdan, Basem Al-Najjar, Hani Al-Masri, Rama Abu Farah, Marwan |
author_facet | Al-Masri, Mahmoud Alawneh, Fade Daoud, Faiez Ebous, Ali Hamdan, Basem Al-Najjar, Hani Al-Masri, Rama Abu Farah, Marwan |
author_sort | Al-Masri, Mahmoud |
collection | PubMed |
description | BACKGROUND/PURPOSE: Seroma is a common complication after axillary dissection in women with node-positive breast cancer. We aim to determine the effect of Cyanoacrylate on reducing seroma formation in patients undergoing axillary dissection. This a randomized clinical trial. METHODS: This is a single-center, randomized, single-blinded, and two-arm parallel study. Women with node-positive breast cancer eligible for axillary dissection were enrolled. Patients with a Body Mass Index (BMI) greater than 35 kg/m(2), those who underwent immediate breast reconstruction, and/or received neoadjuvant chemotherapy were excluded. Patients were randomized in a 1:1 ratio, and were stratified according to their age, BMI, tumor size, and operation type. The primary endpoint was the total seroma volume (the total drained volume and the total aspirated volume after drain removal). Data presented as mean and range when applicable. RESULTS: 111 patients were randomized (Cyanoacrylate 57; control 54). 105 patients were analyzed. Sixty-nine patients underwent breast conserving surgery, and 36 underwent modified radical mastectomy. There was no difference in the total seroma volume between the Cyanoacrylate vs. control arms (1,304 (60–4,950) vs. 1,446 (100–5,223) ml, p=0.458). Wound infection, flap necrosis, number of manual aspirates, and hematoma formation were not statistically different between the two groups. Time to drain removal was shorter in the Cyanoacrylate arm (11.04(3–23) vs. 13.84(3–37) days, p=0.015). The use of Cyanoacrylate was not cost effective ($586.93 (550–748) vs. $29.63 (0–198), p<0.001). Higher seroma volume was correlated with modified radical mastectomy, older age, and BMI more than 30 kg/m(2). CONCLUSION: Cyanoacrylate did not reduce seroma formation and its use was not cost effective. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, identifier NCT02141373. |
format | Online Article Text |
id | pubmed-7868378 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-78683782021-02-09 Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial Al-Masri, Mahmoud Alawneh, Fade Daoud, Faiez Ebous, Ali Hamdan, Basem Al-Najjar, Hani Al-Masri, Rama Abu Farah, Marwan Front Oncol Oncology BACKGROUND/PURPOSE: Seroma is a common complication after axillary dissection in women with node-positive breast cancer. We aim to determine the effect of Cyanoacrylate on reducing seroma formation in patients undergoing axillary dissection. This a randomized clinical trial. METHODS: This is a single-center, randomized, single-blinded, and two-arm parallel study. Women with node-positive breast cancer eligible for axillary dissection were enrolled. Patients with a Body Mass Index (BMI) greater than 35 kg/m(2), those who underwent immediate breast reconstruction, and/or received neoadjuvant chemotherapy were excluded. Patients were randomized in a 1:1 ratio, and were stratified according to their age, BMI, tumor size, and operation type. The primary endpoint was the total seroma volume (the total drained volume and the total aspirated volume after drain removal). Data presented as mean and range when applicable. RESULTS: 111 patients were randomized (Cyanoacrylate 57; control 54). 105 patients were analyzed. Sixty-nine patients underwent breast conserving surgery, and 36 underwent modified radical mastectomy. There was no difference in the total seroma volume between the Cyanoacrylate vs. control arms (1,304 (60–4,950) vs. 1,446 (100–5,223) ml, p=0.458). Wound infection, flap necrosis, number of manual aspirates, and hematoma formation were not statistically different between the two groups. Time to drain removal was shorter in the Cyanoacrylate arm (11.04(3–23) vs. 13.84(3–37) days, p=0.015). The use of Cyanoacrylate was not cost effective ($586.93 (550–748) vs. $29.63 (0–198), p<0.001). Higher seroma volume was correlated with modified radical mastectomy, older age, and BMI more than 30 kg/m(2). CONCLUSION: Cyanoacrylate did not reduce seroma formation and its use was not cost effective. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov, identifier NCT02141373. Frontiers Media S.A. 2021-01-25 /pmc/articles/PMC7868378/ /pubmed/33569343 http://dx.doi.org/10.3389/fonc.2020.580861 Text en Copyright © 2021 Al-Masri, Alawneh, Daoud, Ebous, Hamdan, Al-Najjar, Al-Masri and Abu Farah http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Oncology Al-Masri, Mahmoud Alawneh, Fade Daoud, Faiez Ebous, Ali Hamdan, Basem Al-Najjar, Hani Al-Masri, Rama Abu Farah, Marwan Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial |
title | Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial |
title_full | Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial |
title_fullStr | Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial |
title_full_unstemmed | Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial |
title_short | Effectiveness of Cyanoacrylate in Reducing Seroma Formation in Breast Cancer Patients Post-Axillary Dissection: A Randomized Controlled Trial |
title_sort | effectiveness of cyanoacrylate in reducing seroma formation in breast cancer patients post-axillary dissection: a randomized controlled trial |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7868378/ https://www.ncbi.nlm.nih.gov/pubmed/33569343 http://dx.doi.org/10.3389/fonc.2020.580861 |
work_keys_str_mv | AT almasrimahmoud effectivenessofcyanoacrylateinreducingseromaformationinbreastcancerpatientspostaxillarydissectionarandomizedcontrolledtrial AT alawnehfade effectivenessofcyanoacrylateinreducingseromaformationinbreastcancerpatientspostaxillarydissectionarandomizedcontrolledtrial AT daoudfaiez effectivenessofcyanoacrylateinreducingseromaformationinbreastcancerpatientspostaxillarydissectionarandomizedcontrolledtrial AT ebousali effectivenessofcyanoacrylateinreducingseromaformationinbreastcancerpatientspostaxillarydissectionarandomizedcontrolledtrial AT hamdanbasem effectivenessofcyanoacrylateinreducingseromaformationinbreastcancerpatientspostaxillarydissectionarandomizedcontrolledtrial AT alnajjarhani effectivenessofcyanoacrylateinreducingseromaformationinbreastcancerpatientspostaxillarydissectionarandomizedcontrolledtrial AT almasrirama effectivenessofcyanoacrylateinreducingseromaformationinbreastcancerpatientspostaxillarydissectionarandomizedcontrolledtrial AT abufarahmarwan effectivenessofcyanoacrylateinreducingseromaformationinbreastcancerpatientspostaxillarydissectionarandomizedcontrolledtrial |