Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain
NCT ID: NCT05280353
Last Updated: 2024-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
134 participants
INTERVENTIONAL
2022-04-01
2026-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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lymphadenectomy without drainage and with Glubran
Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain
Glubran 2
Application of Glubran 2 sealant (liquid) in axillary hollow
Lymphadenectomy without drainage
No intervention required, only axillary dissection without drain
No interventions assigned to this group
Interventions
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Glubran 2
Application of Glubran 2 sealant (liquid) in axillary hollow
Eligibility Criteria
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Inclusion Criteria
* Conservative surgery for breast cancer with associated axillary lymphadenectomy
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Consorci Sanitari del Maresme
OTHER
Omphis Foundation
OTHER
Responsible Party
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Sandra Lopez Gordo
Principal investigator
Principal Investigators
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Sandra Lopez Gordo, Doctor
Role: PRINCIPAL_INVESTIGATOR
Health Consortium Maresme
Locations
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Maresme health consortium
Mataró, , Spain
Countries
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Central Contacts
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Facility Contacts
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Sandra lopez gordo
Role: primary
References
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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.
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.
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.
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.
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.
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.
Lopez Gordo S, Ruiz-Edo N, Fernandez-Planas MT, Viscaya-Martin S, Serra-Serra C; Breast Cancer Research Group. Seroma control in axillary lymphadenectomy with Glubran 2(R) without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain). Trials. 2024 Feb 22;25(1):142. doi: 10.1186/s13063-023-07840-w.
Other Identifiers
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Health consortium maresme
Identifier Type: -
Identifier Source: org_study_id
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