Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain (GALA)

Seroma Control in Axillary Lymphadenectomy With Glubran 2® Without Drain. Multicenter, Prospective, Randomized Clinical Trial. GALA-ND Study (Glu Axillary Lymphadenectomy Ambulatory- no Drain)

Axillary lymphadenectomy in breast cancer continues to be a common practice in certain patients. The use of sealants and drains continues to be a source of disagreement among the scientific community. That is why the study was designed to show whether the sealant reduces seroma after axillary lymphadenectomy without drainage.

Study Overview

• Status: Recruiting
• Conditions: Seroma Following Procedure
• Intervention / Treatment: Other: Glubran 2

Detailed Description

A study has been designed to assess whether the sealant reduces the rate of symptomatic seroma measured by the number of evacuating punctures. Likewise, the decrease in volume due to the seroma between the two groups and the quality of life of the patients is assessed, given that none of them has a drain

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra Lopez Gordo; Phone Number: 1141 937 41 77 00; Email: slopezgord@csdm.cat

Study Locations

• Spain
  • Mataró, Spain
    • Recruiting
    • Maresme health consortium
    • Contact: Sandra lopez gordo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 18 years old
• Conservative surgery for breast cancer with associated axillary lymphadenectomy

Exclusion Criteria:

• Mastectomy
• History of axillary surgery or ipsilateral axillary radiotherapy
• ASA 4 patients. (ASA 3 patients selected)
• Lack of adequate cognitive capacity and/or signed informed consent
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lymphadenectomy without drainage and with Glubran; Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain	Other: Glubran 2; Application of Glubran 2 sealant (liquid) in axillary hollow
No Intervention: Lymphadenectomy without drainage; No intervention required, only axillary dissection without drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in symptomatic seroma	Number of evacuating punctures	Up tp 1 year
Number of participants with treatment-related adverse events	Type and number of adverse events	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroma volume	Volume measured by ultrasound (cm3 )	Day 7 and 14 after surgery
Milliliters of evacuated seroma in case of puncture	Assess if there are differences in the volume of seroma evacuated (milliliters) between groups	7, 14 and 30 day after surgery
Demographic characteristics of patients related to seroma	Assess the existence of risk factors (age, sex, obesity,neoadjuvant treatment) related to symptomatic seroma	Up to 1 year
Number of patients with temporary or permanence of disability after operation	Clavien-Dindo classification of morbidity	Up to 1 year
Individual's perception of the position in life of the participants	Assess the quality of life after the intervention measured by the EuroQol five dimensions (EQ-5D-5L questionnaire). Descriptive system for health-related quality of life states in adults, consisting of five dimensions. No quality 0 points. Perfect quality 100 points	Day 7 and 14 after surgery

Collaborators and Investigators

• Sponsor: Omphis Foundation
• Collaborators: Consorci Sanitari del Maresme
• Investigators: Principal Investigator: Sandra Lopez Gordo, Doctor, Health Consortium Maresme

Publications and helpful links

General Publications

• Thorpe KE, Zwarenstein M, Oxman AD, Treweek S, Furberg CD, Altman DG, Tunis S, Bergel E, Harvey I, Magid DJ, Chalkidou K. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. J Clin Epidemiol. 2009 May;62(5):464-75. doi: 10.1016/j.jclinepi.2008.12.011.
• 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 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17.
• 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 Jan;91(1):54-60. doi: 10.1002/bjs.4435.
• Giuliano AE, Ballman KV, McCall L, Beitsch PD, Brennan MB, Kelemen PR, Ollila DW, Hansen NM, Whitworth PW, Blumencranz PW, Leitch AM, Saha S, Hunt KK, Morrow M. 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 Sep 12;318(10):918-926. doi: 10.1001/jama.2017.11470.
• 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 Dec;15(4):373-80. doi: 10.4048/jbc.2012.15.4.373. Epub 2012 Dec 31.
• Thomson DR, Sadideen H, Furniss D. Wound drainage after axillary dissection for carcinoma of the breast. Cochrane Database Syst Rev. 2013 Oct 20;2013(10):CD006823. doi: 10.1002/14651858.CD006823.pub2.
• 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 Dec;27(13):5286-5295. doi: 10.1245/s10434-020-08747-5. Epub 2020 Jun 20.
• 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 Oct;23(10):3347-53. doi: 10.1245/s10434-016-5398-6. Epub 2016 Jul 8.
• 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 Dec;17(8):595-600. doi: 10.1016/j.clbc.2017.04.004. Epub 2017 Apr 13.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: March 12, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Seroma
• Other Study ID Numbers: Health consortium maresme

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No