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

Primary Purpose

Seroma Following Procedure

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Glubran 2
Sponsored by
Omphis Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seroma Following Procedure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Maresme health consortiumRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

lymphadenectomy without drainage and with Glubran

Lymphadenectomy without drainage

Arm Description

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

No intervention required, only axillary dissection without drain

Outcomes

Primary Outcome Measures

Change in symptomatic seroma
Number of evacuating punctures
Number of participants with treatment-related adverse events
Type and number of adverse events

Secondary Outcome Measures

Seroma volume
Volume measured by ultrasound (cm3 )
Milliliters of evacuated seroma in case of puncture
Assess if there are differences in the volume of seroma evacuated (milliliters) between groups
Demographic characteristics of patients related to seroma
Assess the existence of risk factors (age, sex, obesity,neoadjuvant treatment) related to symptomatic seroma
Number of patients with temporary or permanence of disability after operation
Clavien-Dindo classification of morbidity
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

Full Information

First Posted
February 8, 2022
Last Updated
November 24, 2022
Sponsor
Omphis Foundation
Collaborators
Consorci Sanitari del Maresme
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1. Study Identification

Unique Protocol Identification Number
NCT05280353
Brief Title
Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain
Acronym
GALA
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Omphis Foundation
Collaborators
Consorci Sanitari del Maresme

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seroma Following Procedure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
MULTICENTRIC, PROSPECTIVE, RANDOMIZED CLINICAL TRIAL
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lymphadenectomy without drainage and with Glubran
Arm Type
Experimental
Arm Description
Application of Glubran 2 in axillary dissection with the objective of seroma reduction. No drain
Arm Title
Lymphadenectomy without drainage
Arm Type
No Intervention
Arm Description
No intervention required, only axillary dissection without drain
Intervention Type
Other
Intervention Name(s)
Glubran 2
Intervention Description
Application of Glubran 2 sealant (liquid) in axillary hollow
Primary Outcome Measure Information:
Title
Change in symptomatic seroma
Description
Number of evacuating punctures
Time Frame
Up tp 1 year
Title
Number of participants with treatment-related adverse events
Description
Type and number of adverse events
Time Frame
Up to 1 year
Secondary Outcome Measure Information:
Title
Seroma volume
Description
Volume measured by ultrasound (cm3 )
Time Frame
Day 7 and 14 after surgery
Title
Milliliters of evacuated seroma in case of puncture
Description
Assess if there are differences in the volume of seroma evacuated (milliliters) between groups
Time Frame
7, 14 and 30 day after surgery
Title
Demographic characteristics of patients related to seroma
Description
Assess the existence of risk factors (age, sex, obesity,neoadjuvant treatment) related to symptomatic seroma
Time Frame
Up to 1 year
Title
Number of patients with temporary or permanence of disability after operation
Description
Clavien-Dindo classification of morbidity
Time Frame
Up to 1 year
Title
Individual's perception of the position in life of the participants
Description
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
Time Frame
Day 7 and 14 after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Lopez Gordo
Phone
937 41 77 00
Ext
1141
Email
slopezgord@csdm.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Lopez Gordo, Doctor
Organizational Affiliation
Health Consortium Maresme
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maresme health consortium
City
Mataró
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra lopez gordo

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28898379
Citation
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.
Results Reference
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PubMed Identifier
21849243
Citation
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.
Results Reference
background
PubMed Identifier
23346164
Citation
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.
Results Reference
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PubMed Identifier
24158902
Citation
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.
Results Reference
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PubMed Identifier
32564232
Citation
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.
Results Reference
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PubMed Identifier
27393569
Citation
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.
Results Reference
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PubMed Identifier
14716794
Citation
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.
Results Reference
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PubMed Identifier
28673765
Citation
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.
Results Reference
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PubMed Identifier
19348971
Citation
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.
Results Reference
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Use of Glubran 2 ® in Axillary Lymphadenectomy Without Drain

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