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

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2024年2月22日

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Sandra López Gordo,
Neus Ruiz-Edo,
Maria Teresa Fernández-Planas,
Sara Viscaya-Martín,
Cristina Serra-Serra,
Carmen Buqueras,
Mireia Recaj,
Raul Guerrero-López,
Lidia Blay-Aulina,
Oscar Aparicio-Rodriguez,
Laura Cusiné,
Xavier Mira,
Montserrat Clos,
Immaculada Alonso,
Jairo Cortés Prados,
Sofía Espinoza Villalobos,
Elena Vallejo-Barnosell,
A. S. Espinoza-Villalobos,
Marta Jimenez,
Aurora Carrasquer-Puyal,
Priscila Giselle Holub,
Maria José Cases Baldo,
E. Garcia de Castro R,
Inmaculada Herrador Garcia,
Emanuela Esposito,
E. Garcia de Castro Rubio,
Marta Lourdes Gonzalez Duaigues

摘要

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.