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Seroma Following ProcedureGALANCT05280353

Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

A study testing Glubran 2 in people with Seroma Following Procedure, run by Omphis Foundation at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Seroma Following Procedure
What is being tested?
Glubran 2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteSpain
Study dates
1 Apr 2022to 1 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sandra Lopez Gordo contact

937 41 77 00 ext. 1141

slopezgord@csdm.cat

Spain1 site, 1 recruiting

  • Maresme health consortium

    Mataró

    Sandra lopez gordo

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read the 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

Being tested
Glubran 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glubran 2Other

    Application of Glubran 2 sealant (liquid) in axillary hollow

Study groups in NCT05280353
Study groupRoleWhat they receive
lymphadenectomy without drainage and with GlubranExperimentalApplication of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain
Receives: Other: Glubran 2
Lymphadenectomy without drainageNo interventionNo intervention required, only axillary dissection without drain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in symptomatic seroma

    Number of evacuating punctures

    Measured: Up tp 1 year

  2. Number of participants with treatment-related adverse events

    Type and number of adverse events

    Measured: Up to 1 year

Secondary outcomes (5)

  1. Seroma volume

    Volume measured by ultrasound (cm3 )

    Measured: Day 7 and 14 after surgery

  2. Milliliters of evacuated seroma in case of puncture

    Assess if there are differences in the volume of seroma evacuated (milliliters) between groups

    Measured: 7, 14 and 30 day after surgery

  3. Demographic characteristics of patients related to seroma

    Assess the existence of risk factors (age, sex, obesity,neoadjuvant treatment) related to symptomatic seroma

    Measured: Up to 1 year

  4. Number of patients with temporary or permanence of disability after operation

    Clavien-Dindo classification of morbidity

    Measured: Up to 1 year

  5. 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

    Measured: Day 7 and 14 after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start1 Apr 2022
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
MULTICENTRIC, PROSPECTIVE, RANDOMIZED CLINICAL TRIAL
Masking
None (open label)
Enrolment
134 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05280353
Sponsor's protocol ID
Health consortium maresme
Acronym
GALA
Status last verified
Sep 2024
First submitted
8 Feb 2022
Last updated
4 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28898379

  • 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.

    PubMed 21849243

  • 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.

    PubMed 23346164

  • 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.

    PubMed 24158902

  • 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.

    PubMed 32564232

  • 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.

    PubMed 27393569

  • 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.

    PubMed 14716794

  • 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.

    PubMed 28673765

  • 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.

    PubMed 19348971

  • 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.

    PubMed 38388444

Questions about this trial

What is this clinical trial studying?

A study testing Glubran 2 in people with Seroma Following Procedure, run by Omphis Foundation at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sandra Lopez Gordo (937 41 77 00 ext. 1141, slopezgord@csdm.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in symptomatic seroma (time frame: Up tp 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05280353, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2024.

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