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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Seroma | Study protocol

Seroma control in axillary lymphadenectomy with Glubran 2® without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain)

Authors: Sandra López Gordo, Neus Ruiz-Edo, Maria Teresa Fernández-Planas, Sara Viscaya-Martín, Cristina Serra-Serra, Breast Cancer Research Group

Published in: Trials | Issue 1/2024

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Abstract

Background

Seroma after breast cancer surgery is a frequent entity; therefore, different products have been described in literature with the aim to reduce it. The most studied ones have been the sealants products, being tested with aspirative drains. Symptomatic seroma represents the 19% after axillary lymphadenectomy without drains. The aim of this study is to analyze the effect of a sealant in the seroma control after axillary lymphadenectomy without drains and identify the risk factors related to symptomatic seroma.

Methods

This is a prospective, multicenter, international, and randomized clinical trial. Patients undergoing conservative surgery and axillary lymphadenectomy for breast cancer will be randomized to control group (lymphadenectomy without sealant) or interventional group (lymphadenectomy with sealant Glubran 2®). In any of the study groups, drains are placed. Patients who received neoadjuvant treatment are included. Measurements of the study outcomes will take place at baseline; at 7, 14, and 30 days post-surgery; and at 6–12 months. The primary outcome is symptomatic seroma. Secondary outcomes are seroma volume, morbidity, quality of life, and lymphedema.

Discussion

Several studies compare the use of sealant products in axillary lymphadenectomy but generally with drains. We would like to demonstrate that patients who underwent axillary lymphadenectomy could benefit from an axillary sealant without drains and reduce axillary discomfort while maintaining a good quality of life. Assessing the relationship between axillary volume, symptoms, and related risk factors can be of great help in the control of seroma in patients who received breast cancer surgery.

Trial registration

ClinicalTrials.gov, NCT05280353. Registration date 02 August 2022.
Literature
1.
2.
Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance) randomized clinical trial. JAMA. 2017;318(10):918–26.CrossRefPubMedPubMedCentral
3.
van Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011;37(10):829–35.CrossRefPubMed
4.
Srivastava V, Basu S, Shukla VK. Seroma formation after breast cancer surgery: what we have learned in the last two decades. J Breast Cancer. 2012;15(4):373–80.CrossRefPubMedPubMedCentral
5.
Thomson DR, Sadideen H, Furniss D. Wound drainage after axillary dissection for carcinoma of the breast. Cochrane Database Syst Rev. 2013;10:CD006823.
6.
Conversano A, Mazouni C, Thomin A, Gaudin A, Fournier M, Rimareix F, et al. Use of low-thrombin fibrin sealant glue after axillary lymphadenectomy for breast cancer to reduce hospital length and seroma. Clin Breast Cancer. 2017;17(4):293–7.CrossRefPubMed
7.
Chang YT, Shih SL, Loh EW, Tam KW. Effects of fibrin sealant on seroma reduction for patients with breast cancer undergoing axillary dissection: meta-analysis of randomized controlled trials. Ann Surg Oncol. 2020;27(13):5286–95.CrossRefPubMed
8.
Gunn J, Gibson T, Li Z, Diehl N, Bagaria S, McLaughlin S. Symptomatic axillary seroma after sentinel lymph node biopsy: incidence and treatment. Ann Surg Oncol. 2016;23(10):3347–53.CrossRefPubMed
9.
Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004;91(1):54–60.CrossRefPubMed
10.
Vasileiadou K, Kosmidis C, Anthimidis G, Miliaras S, Kostopoulos I, Fahantidis E. Cyanoacrylate adhesive reduces seroma production after modified radical mastectomy or quadrantectomy with lymph node dissection-a prospective randomized clinical trial. Clin Breast Cancer. 2017;17(8):595–600.CrossRefPubMed
11.
Ramos D, Vazquez-Sequeiros E, Abadia P, Pina JD, Moreno I, Die Trill J, et al. Endoscopic management of acute anastomotic leakage after low colorectal anastomosis with cyanoacrylate bioglue (Glubran 2). Endoscopy. 2021;53(4):E136–7.CrossRefPubMed
12.
Hernandez G, Garin O, Pardo Y, Vilagut G, Pont A, Suarez M, et al. Validity of the EQ-5D-5L and reference norms for the Spanish population. Qual Life Res. 2018;27(9):2337–48.CrossRefPubMed
13.
Patrone R, Granata V, Belli A, Palaia R, Albino V, Piccirillo M, et al. The safety and efficacy of Glubran 2 as biliostatic agent in liver resection. Infect Agent Cancer. 2021;16(1):19.CrossRefPubMedPubMedCentral
Metadata
Title
Seroma control in axillary lymphadenectomy with Glubran 2® without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain)
Authors
Sandra López Gordo
Neus Ruiz-Edo
Maria Teresa Fernández-Planas
Sara Viscaya-Martín
Cristina Serra-Serra
Breast Cancer Research Group
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-023-07840-w

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