Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

NCT05280353 | Recruiting

• 1 other identifier: Health consortium maresme
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Seroma Following Procedure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Seroma volume

  Day 7 and 14 after surgery

• Milliliters of evacuated seroma in case of puncture

  7, 14 and 30 day after surgery

• Demographic characteristics of patients related to seroma

  Up to 1 year

• Number of patients with temporary or permanence of disability after operation

  Up to 1 year

• Individual's perception of the position in life of the participants

  Day 7 and 14 after surgery

Study Arms (2)

lymphadenectomy without drainage and with Glubran

EXPERIMENTAL

Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain

Other: Glubran 2

Lymphadenectomy without drainage

NO INTERVENTION

No intervention required, only axillary dissection without drain

Interventions

Glubran 2 OTHER

Application of Glubran 2 sealant (liquid) in axillary hollow

lymphadenectomy without drainage and with Glubran

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Omphis Foundation: lead
• Consorci Sanitari del Maresme: collaborator

Study Sites (1)

Maresme health consortium

Mataró, Spain

RECRUITING

Related Publications (10)

• 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.

  PMID: 28898379 BACKGROUND

• 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.

  PMID: 21849243 BACKGROUND

• 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.

  PMID: 23346164 BACKGROUND

• 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.

  PMID: 24158902 BACKGROUND

• 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.

  PMID: 32564232 BACKGROUND

• 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.

  PMID: 27393569 BACKGROUND

• 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.

  PMID: 14716794 BACKGROUND

• 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.

  PMID: 28673765 BACKGROUND

• 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.

  PMID: 19348971 BACKGROUND

• 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.

  PMID: 38388444 DERIVED

MeSH Terms

Interventions

glubran 2

Study Officials

• Sandra Lopez Gordo, Doctor

  Health Consortium Maresme

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra Lopez Gordo

CONTACT

937 41 77 00; slopezgord@csdm.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: MULTICENTRIC, PROSPECTIVE, RANDOMIZED CLINICAL TRIAL

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 15, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)